A Real-World Evidence Study to Evaluate Oral Health Related Quality of Life Using an Anti-Sensitivity Toothpaste

A Real-World Evidence Study Evaluating Oral Health Related Quality of Life Following the Use of Antisensitivity Toothpaste for Dentine Hypersensitivity Management

The purpose of this study is to evaluate changes in oral health-related quality of life (OHrQoL) in participants suffering from Dentinal Hypersensitivity (DH) symptoms following the use of anti-sensitivity toothpaste for 24 weeks.

Study Overview

• Status: Completed
• Conditions: Dentin Sensitivity
• Intervention / Treatment: Other: Potassium Nitrate + Sodium Fluoride

Detailed Description

This study will be a virtual, prospective, twenty-four weeks, open label study in participants with DH (self-reported symptoms). Participants self-perception of DH will be evaluated by completion of a validated OHrQoL questionnaire (Dentin Hypersensitivity Experience Questionnaire-48 [DHEQ-48]) at baseline, 4, 8, 12, 16, 20 and 24 weeks.

• Study Type: Interventional
• Enrollment (Actual): 655
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Orlando, Florida, United States, 32817
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Provision of consent indicating that the participant has been informed of all pertinent aspects of the study.
• The participant must be able to complete all activities as shown in the Schedule of Activities independently on their smart devices.
• Participant who has tooth sensitivity (self-reported symptoms).

Exclusion Criteria:

• A participant whose sensitivity could be caused by other factors or clinical pathology as established by the screening questionnaire, which also includes:

  • A participant who has been/is on multiple prescription medications to treat severe acid reflux on regular basis or considered surgery for acid reflux
  • A participant with full or partial denture
  • A participant who has undergone treatment within 6 months of screening or is currently under treatment for periodontal or gum disease
  • A participant with active periodontitis
  • A participant with active caries
  • A participant with any chronic and/or severe painful health conditions which lead to regular use pain medications (more than 3 days a week)
• A participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients: potassium nitrate (5 percent [%]), sodium fluoride (0.15% weight/volume [w/v] fluoride ion), water, sorbitol, hydrated silica, glycerin, cocamidopropyl betaine, flavor, xanthan gum, titanium dioxide, sodium saccharin, sodium hydroxide, sucralose, yellow 10, blue 1.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Sensodyne Fresh Mint Toothpaste; Participants will be asked to follow commercial tube instructions as recommended for sensitivity relief: "Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing, Spit out after brushing."

Other: Potassium Nitrate + Sodium Fluoride; Potassium Nitrate 5% weight/weight (w/w) and Sodium Fluoride 0.15% weight/volume (w/v) fluoride ion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Score of DHEQ Section 1 - Impact on Everyday Life (Question [Q]1-3) at Baseline (Day 0)	All the participants scored question No. 1 to 3 ([Q1: On a scale of 1 to 10 how intense were the sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1 is equal to (=) not at all intense and 10= worst imaginable, [Q2: On a scale of 1 to 10 how bothered were you by any sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Not at all bothered and 10= Extremely bothered], [Q3: On a scale of 1 to 10 how well could you tolerate sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Can easily tolerate and 10= Can't tolerate at all]). Section 1 of DHEQ consisted of questions about participant's sensitive teeth and the impact they had on participant's everyday life. Lower is the score, better is the improvement in Oral Health-related Quality of Life (OHrQoL). Baseline was defined as Day 0 value.	Baseline (Day 0)
Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 4	All the participants scored question No. 1 to 3 ([Q1: On a scale of 1 to 10 how intense were the sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= not at all intense and 10= worst imaginable, [Q2: On a scale of 1 to 10 how bothered were you by any sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Not at all bothered and 10= Extremely bothered], [Q3: On a scale of 1 to 10 how well could you tolerate sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Can easily tolerate and 10= Can't tolerate at all]). Section 1 of DHEQ consisted of questions about participant's sensitive teeth and the impact they had on participant's everyday life. Lower is the score, better is the improvement in OHrQoL.	Week 4
Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 8	All the participants scored question No. 1 to 3 ([Q1: On a scale of 1 to 10 how intense are the sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= not at all intense and 10= worst imaginable, [Q2: On a scale of 1 to 10 how bothered are you by any sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Not at all bothered and 10= Extremely bothered], [Q3: On a scale of 1 to 10 how well can you tolerate sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Can easily tolerate and 10= Can't tolerate at all]). Section 1 of DHEQ consisted of questions about participant's sensitive teeth and the impact they had on participant's everyday life. Lower is the score, better is the improvement in OHrQoL.	Week 8
Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 12	All the participants scored question No. 1 to 3 ([Q1: On a scale of 1 to 10 how intense are the sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= not at all intense and 10= worst imaginable, [Q2: On a scale of 1 to 10 how bothered are you by any sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Not at all bothered and 10= Extremely bothered], [Q3: On a scale of 1 to 10 how well can you tolerate sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Can easily tolerate and 10= Can't tolerate at all]). Section 1 of DHEQ consisted of questions about participant's sensitive teeth and the impact they had on participant's everyday life. Lower is the score, better is the improvement in OHrQoL.	Week 12
Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 16	All the participants scored question No. 1 to 3 ([Q1: On a scale of 1 to 10 how intense are the sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= not at all intense and 10= worst imaginable, [Q2: On a scale of 1 to 10 how bothered are you by any sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Not at all bothered and 10= Extremely bothered], [Q3: On a scale of 1 to 10 how well can you tolerate sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Can easily tolerate and 10= Can't tolerate at all]). Section 1 of DHEQ consisted of questions about participant's sensitive teeth and the impact they had on participant's everyday life. Lower is the score, better is the improvement in OHrQoL.	Week 16
Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 20	All the participants scored question No. 1 to 3 ([Q1: On a scale of 1 to 10 how intense are the sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= not at all intense and 10= worst imaginable, [Q2: On a scale of 1 to 10 how bothered are you by any sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Not at all bothered and 10= Extremely bothered], [Q3: On a scale of 1 to 10 how well can you tolerate sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Can easily tolerate and 10= Can't tolerate at all]). Section 1 of DHEQ consisted of questions about participant's sensitive teeth and the impact they had on participant's everyday life. Lower is the score, better is the improvement in OHrQoL.	Week 20
Mean Score of DHEQ Section 1 - Impact on Everyday Life (Q1-3) at Week 24	All the participants scored question No. 1 to 3 ([Q1: On a scale of 1 to 10 how intense are the sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= not at all intense and 10= worst imaginable, [Q2: On a scale of 1 to 10 how bothered are you by any sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Not at all bothered and 10= Extremely bothered], [Q3: On a scale of 1 to 10 how well can you tolerate sensations?] of section 1 of DHEQ on a scale of 1 to 10, where 1= Can easily tolerate and 10= Can't tolerate at all]). Section 1 of DHEQ consisted of questions about participant's sensitive teeth and the impact they had on participant's everyday life. Lower is the score, better is the improvement in OHrQoL.	Week 24
Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Baseline (Day 0)	All participants scored 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 included questions assessing how sensitivity impacts the way a participant acts and feels. Total score was derived from the sum of scores of all 34 questions present in section 2 of the DHEQ. Total scores range from 238 to 34 points, lower is the score, better is the improvement in OHrQoL. Baseline was defined as Day 0 value.	Baseline (Day 0)
Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 4	All participants scored 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 included questions assessing how sensitivity impacts the way a participant acts and feels. Total score was derived from the sum of scores of all 34 questions present in section 2 of the DHEQ. Total scores range from 238 to 34 points, lower is the score, better is the improvement in OHrQoL.	Week 4
Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 8	All participants scored 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 included questions assessing how sensitivity impacts the way a participant acts and feels. Total score was derived from the sum of scores of all 34 questions present in section 2 of the DHEQ. Total scores range from 238 to 34 points, lower is the score, better is the improvement in OHrQoL.	Week 8
Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 12	All participants scored 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 included questions assessing how sensitivity impacts the way a participant acts and feels. Total score was derived from the sum of scores of all 34 questions present in section 2 of the DHEQ. Total scores range from 238 to 34 points, lower is the score, better is the improvement in OHrQoL.	Week 12
Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 16	All participants scored 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 included questions assessing how sensitivity impacts the way a participant acts and feels. Total score was derived from the sum of scores of all 34 questions present in section 2 of the DHEQ. Total scores range from 238 to 34 points, lower is the score, better is the improvement in OHrQoL.	Week 16
Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 20	All participants scored 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 included questions assessing how sensitivity impacts the way a participant acts and feels. Total score was derived from the sum of scores of all 34 questions present in section 2 of the DHEQ. Total scores range from 238 to 34 points, lower is the score, better is the improvement in OHrQoL.	Week 20
Mean Score of DHEQ Section 2 - Total Score (Q1-34) at Week 24	All participants scored 34 questions present in section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Section 2 included questions assessing how sensitivity impacts the way a participant acts and feels. Total score was derived from the sum of scores of all 34 questions present in section 2 of the DHEQ. Total scores range from 238 to 34 points, lower is the score, better is the improvement in OHrQoL.	Week 24
Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Baseline (Day 0)	All participants scored 4 questions present in Domain "Restriction" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of questions Q1-Q4. Domain Restriction score was derived by sum of Q1-Q4 (section 2 DHEQ). Domain Restriction scores range from 28-4, lower is the score, better is the improvement in OHrQoL. Baseline was defined as Day 0 value.	Baseline (Day 0)
Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 4	All participants scored 4 questions present in Domain "Restriction" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of questions Q1-Q4. Domain Restriction score was derived by sum of Q1-Q4 (section 2 DHEQ). Domain Restriction scores range from 28-4, lower is the score, better is the improvement in OHrQoL.	Week 4
Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 8	All participants scored 4 questions present in Domain "Restriction" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of questions Q1-Q4. Domain Restriction score was derived by sum of Q1-Q4 (section 2 DHEQ). Domain Restriction scores range from 28-4, lower is the score, better is the improvement in OHrQoL.	Week 8
Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 12	All participants scored 4 questions present in Domain "Restriction" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of questions Q1-Q4. Domain Restriction score was derived by sum of Q1-Q4 (section 2 DHEQ). Domain Restriction scores range from 28-4, lower is the score, better is the improvement in OHrQoL.	Week 12
Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 16	All participants scored 4 questions present in Domain "Restriction" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of questions Q1-Q4. Domain Restriction score was derived by sum of Q1-Q4 (section 2 DHEQ). Domain Restriction scores range from 28-4, lower is the score, better is the improvement in OHrQoL.	Week 16
Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 20	All participants scored 4 questions present in Domain "Restriction" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of questions Q1-Q4. Domain Restriction score was derived by sum of Q1-Q4 (section 2 DHEQ). Domain Restriction scores range from 28-4, lower is the score, better is the improvement in OHrQoL.	Week 20
Mean Score of DHEQ Section 2 - Restrictions (Q1-4) at Week 24	All participants scored 4 questions present in Domain "Restriction" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Restriction domain consisted of questions Q1-Q4. Domain Restriction score was derived by sum of Q1-Q4 (section 2 DHEQ). Domain Restriction scores range from 28-4, lower is the score, better is the improvement in OHrQoL.	Week 24
Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Baseline (Day 0)	All participants scored 12 questions present in Domain "Adaptation" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of 12 questions (Q5-16). Adaptation domain score was derived by sum of Q5-Q16 (section 2 DHEQ). Domain Adaptation scores range from 84-12, lower is the score, better is the improvement in OHrQoL. Baseline was defined as Day 0 value.	Baseline (Day 0)
Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 4	All participants scored 12 questions present in Domain "Adaptation" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of 12 questions (Q5-16). Adaptation domain score was derived by sum of Q5-Q16 (section 2 DHEQ). Domain Adaptation scores range from 84-12, lower is the score, better is the improvement in OHrQoL.	Week 4
Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 8	All participants scored 12 questions present in Domain "Adaptation" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of 12 questions (Q5-16). Adaptation domain score was derived by sum of Q5-Q16 (section 2 DHEQ). Domain Adaptation scores range from 84-12, lower is the score, better is the improvement in OHrQoL.	Week 8
Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 12	All participants scored 12 questions present in Domain "Adaptation" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of 12 questions (Q5-16). Adaptation domain score was derived by sum of Q5-Q16 (section 2 DHEQ). Domain Adaptation scores range from 84-12, lower is the score, better is the improvement in OHrQoL.	Week 12
Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 16	All participants scored 12 questions present in Domain "Adaptation" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of 12 questions (Q5-16). Adaptation domain score was derived by sum of Q5-Q16 (section 2 DHEQ). Domain Adaptation scores range from 84-12, lower is the score, better is the improvement in OHrQoL.	Week 16
Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 20	All participants scored 12 questions present in Domain "Adaptation" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of 12 questions (Q5-16). Adaptation domain score was derived by sum of Q5-Q16 (section 2 DHEQ). Domain Adaptation scores range from 84-12, lower is the score, better is the improvement in OHrQoL.	Week 20
Mean Score of DHEQ Section 2 - Adaptation (Q5-16) at Week 24	All participants scored 12 questions present in Domain "Adaptation" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Adaptation domain consisted of 12 questions (Q5-16). Adaptation domain score was derived by sum of Q5-Q16 (section 2 DHEQ). Domain Adaptation scores range from 84-12, lower is the score, better is the improvement in OHrQoL.	Week 24
Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Baseline (Day 0)	All participants scored 5 questions present in Domain "Social Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of questions Q17-Q21. Social Impact domain score was derived by sum of Q17-Q21 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL. Baseline was defined as Day 0 value.	Baseline (Day 0)
Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 4	All participants scored 5 questions present in Domain "Social Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of questions Q17-Q21. Social Impact domain score was derived by sum of Q17-Q21 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL.	Week 4
Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 8	All participants scored 5 questions present in Domain "Social Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of questions Q17-Q21. Social Impact domain score was derived by sum of Q17-Q21 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL.	Week 8
Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 12	All participants scored 5 questions present in Domain "Social Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of questions Q17-Q21. Social Impact domain score was derived by sum of Q17-Q21 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL.	Week 12
Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 16	All participants scored 5 questions present in Domain "Social Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of questions Q17-Q21. Social Impact domain score was derived by sum of Q17-Q21 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL.	Week 16
Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 20	All participants scored 5 questions present in Domain "Social Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of questions Q17-Q21. Social Impact domain score was derived by sum of Q17-Q21 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL.	Week 20
Mean Score of DHEQ Section 2 - Social Impact (Q17-21) at Week 24	All participants scored 5 questions present in Domain "Social Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Social Impact domain consisted of questions Q17-Q21. Social Impact domain score was derived by sum of Q17-Q21 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL.	Week 24
Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Baseline (Day 0)	All participants scored 8 questions present in Domain "Emotional Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of questions Q22- Q29. Emotional Impact domain score was derived by sum of Q22-Q29 (section 2 DHEQ). Scores range from 56-8, lower is the score, better is the improvement in OHrQoL. Baseline was defined as Day 0 value.	Baseline (Day 0)
Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 4	All participants scored 8 questions present in Domain "Emotional Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of questions Q22- Q29. Emotional Impact domain score was derived by sum of Q22-Q29 (section 2 DHEQ). Scores range from 56-8, lower is the score, better is the improvement in OHrQoL.	Week 4
Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 8	All participants scored 8 questions present in Domain "Emotional Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of questions Q22- Q29. Emotional Impact domain score was derived by sum of Q22-Q29 (section 2 DHEQ). Scores range from 56-8, lower is the score, better is the improvement in OHrQoL.	Week 8
Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 12	All participants scored 8 questions present in Domain "Emotional Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of questions Q22- Q29. Emotional Impact domain score was derived by sum of Q22-Q29 (section 2 DHEQ). Scores range from 56-8, lower is the score, better is the improvement in OHrQoL.	Week 12
Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 16	All participants scored 8 questions present in Domain "Emotional Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of questions Q22- Q29. Emotional Impact domain score was derived by sum of Q22-Q29 (section 2 DHEQ). Scores range from 56-8, lower is the score, better is the improvement in OHrQoL.	Week 16
Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 20	All participants scored 8 questions present in Domain "Emotional Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of questions Q22- Q29. Emotional Impact domain score was derived by sum of Q22-Q29 (section 2 DHEQ). Scores range from 56-8, lower is the score, better is the improvement in OHrQoL.	Week 20
Mean Score of DHEQ Section 2 - Emotional Impact (Q22-29) at Week 24	All participants scored 8 questions present in Domain "Emotional Impact" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6=Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Emotional Impact domain consisted of questions Q22- Q29. Emotional Impact domain score was derived by sum of Q22-Q29 (section 2 DHEQ). Scores range from 56-8, lower is the score, better is the improvement in OHrQoL.	Week 24
Mean Score of DHEQ Section 2 - Identity (Q30-34) at Baseline (Day 0)	All participants scored 5 questions present in Domain "Identity" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of questions Q30- Q34. Identity domain score was derived by sum of Q30-34 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL. Baseline was defined as Day 0 value.	Baseline (Day 0)
Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 4	All participants scored 5 questions present in Domain "Identity" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of questions Q30- Q34. Identity domain score was derived by sum of Q30-34 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL.	Week 4
Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 8	All participants scored 5 questions present in Domain "Identity" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of questions Q30- Q34. Identity domain score was derived by sum of Q30-34 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL.	Week 8
Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 12	All participants scored 5 questions present in Domain "Identity" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of questions Q30- Q34. Identity domain score was derived by sum of Q30-34 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL.	Week 12
Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 16	All participants scored 5 questions present in Domain "Identity" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of questions Q30- Q34. Identity domain score was derived by sum of Q30-34 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL.	Week 16
Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 20	All participants scored 5 questions present in Domain "Identity" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of questions Q30- Q34. Identity domain score was derived by sum of Q30-34 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL.	Week 20
Mean Score of DHEQ Section 2 - Identity (Q30-34) at Week 24	All participants scored 5 questions present in Domain "Identity" of section 2 of the DHEQ using a 7-point scale, where 7= Strongly agree, 6= Agree, 5= Agree a little, 4= neither agree or disagree, 3= disagree a little, 2= disagree, and 1= strongly disagree. Identity domain consisted of questions Q30- Q34. Identity domain score was derived by sum of Q30-34 (section 2 DHEQ). Scores range from 35-5, lower is the score, better is the improvement in OHrQoL.	Week 24
Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Baseline (Day 0)	All participants scored one question (Q35) of section 2 of DHEQ to asses Domain "Global oral health" using 6-point scale, where 6=Very poor, 5= poor, 4= Fair, 3= Good, 2= Very good, and 1= excellent. Global oral health domain consisted of Q35. Scores range from 6-1, lower is the score, better is the improvement in OHrQoL. Baseline was defined as Day 0 value.	Baseline (Day 0)
Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 4	All participants scored one question (Q35) of section 2 of DHEQ to asses Domain "Global oral health" using 6-point scale, where 6=Very poor, 5= poor, 4= Fair, 3= Good, 2= Very good, and 1= excellent. Global oral health domain consisted of Q35. Scores range from 6-1, lower is the score, better is the improvement in OHrQoL.	Week 4
Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 8	All participants scored one question (Q35) of section 2 of DHEQ to asses Domain "Global oral health" using 6-point scale, where 6=Very poor, 5= poor, 4= Fair, 3= Good, 2= Very good, and 1= excellent. Global oral health domain consisted of Q35. Scores range from 6-1, lower is the score, better is the improvement in OHrQoL.	Week 8
Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 12	All participants scored one question (Q35) of section 2 of DHEQ to asses Domain "Global oral health" using 6-point scale, where 6=Very poor, 5= poor, 4= Fair, 3= Good, 2= Very good, and 1= excellent. Global oral health domain consisted of Q35. Scores range from 6-1, lower is the score, better is the improvement in OHrQoL.	Week 12
Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 16	All participants scored one question (Q35) of section 2 of DHEQ to asses Domain "Global oral health" using 6-point scale, where 6=Very poor, 5= poor, 4= Fair, 3= Good, 2= Very good, and 1= excellent. Global oral health domain consisted of Q35. Scores range from 6-1, lower is the score, better is the improvement in OHrQoL.	Week 16
Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 20	All participants scored one question (Q35) of section 2 of DHEQ to asses Domain "Global oral health" using 6-point scale, where 6=Very poor, 5= poor, 4= Fair, 3= Good, 2= Very good, and 1= excellent. Global oral health domain consisted of Q35. Scores range from 6-1, lower is the score, better is the improvement in OHrQoL.	Week 20
Mean Score of DHEQ Section 2 - Global Oral Health Score (Q35) at Week 24	All participants scored one question (Q35) of section 2 of DHEQ to asses Domain "Global oral health" using 6-point scale, where 6=Very poor, 5= poor, 4= Fair, 3= Good, 2= Very good, and 1= excellent. Global oral health domain consisted of Q35. Scores range from 6-1, lower is the score, better is the improvement in OHrQoL.	Week 24
Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Baseline (Day 0)	All participants scored 4 questions present in Domain "Effect on Life Overall" of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not at all. Effect on Life Overall domain consisted of Q36 - 39. Effect on Life Overall domain score was derived by sum of Q36-39 (section 2 DHEQ). Scores range from 20-0, lower is the score, better is the improvement in OHrQoL. Baseline was defined as Day 0 value.	Baseline (Day 0)
Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 4	All participants scored 4 questions present in Domain "Effect on Life Overall" of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not at all. Effect on Life Overall domain consisted of Q36 - 39. Effect on Life Overall domain score was derived by sum of Q36-39 (section 2 DHEQ). Scores range from 20-0, lower is the score, better is the improvement in OHrQoL.	Week 4
Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 8	All participants scored 4 questions present in Domain "Effect on Life Overall" of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not at all. Effect on Life Overall domain consisted of Q36 - 39. Effect on Life Overall domain score was derived by sum of Q36-39 (section 2 DHEQ). Scores range from 20-0, lower is the score, better is the improvement in OHrQoL.	Week 8
Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 12	All participants scored 4 questions present in Domain "Effect on Life Overall" of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not at all. Effect on Life Overall domain consisted of Q36 - 39. Effect on Life Overall domain score was derived by sum of Q36-39 (section 2 DHEQ). Scores range from 20-0, lower is the score, better is the improvement in OHrQoL.	Week 12
Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 16	All participants scored 4 questions present in Domain "Effect on Life Overall" of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not at all. Effect on Life Overall domain consisted of Q36 - 39. Effect on Life Overall domain score was derived by sum of Q36-39 (section 2 DHEQ). Scores range from 20-0, lower is the score, better is the improvement in OHrQoL.	Week 16
Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 20	All participants scored 4 questions present in Domain "Effect on Life Overall" of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not at all. Effect on Life Overall domain consisted of Q36 - 39. Effect on Life Overall domain score was derived by sum of Q36-39 (section 2 DHEQ). Scores range from 20-0, lower is the score, better is the improvement in OHrQoL.	Week 20
Mean Score of DHEQ Section 2 - Effect of Life Overall Score (Q36 - 39) at Week 24	All participants scored 4 questions present in Domain "Effect on Life Overall" of section 2 of the DHEQ using a 5-point scale, 4= Very Much, 3= Quite a bit, 2= somewhat, and 1= a little, 0=not at all. Effect on Life Overall domain consisted of Q36 - 39. Effect on Life Overall domain score was derived by sum of Q36-39 (section 2 DHEQ). Scores range from 20-0, lower is the score, better is the improvement in OHrQoL.	Week 24

Collaborators and Investigators

• Sponsor: HALEON
• Investigators: Study Director: GSK Clinical Trials, OBVIO HEALTH USA, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): August 31, 2021
• Primary Completion (Actual): May 13, 2022
• Study Completion (Actual): May 13, 2022

Study Registration Dates

• First Submitted: July 6, 2021
• First Submitted That Met QC Criteria: July 6, 2021
• First Posted (Actual): July 15, 2021

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: April 17, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Stomatognathic Diseases; Tooth Diseases; Hypersensitivity; Dentin Sensitivity; Physiological Effects of Drugs; Anti-Infective Agents, Local; Anti-Infective Agents; Protective Agents; Cariostatic Agents; Listerine; Fluorides; Sodium Fluoride
• Other Study ID Numbers: 216953

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
• IPD Sharing Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
• IPD Sharing Access Criteria: Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No