A Real-World Evidence Study Evaluating Oral Health Related Quality Of Life With Use Of A Stannous Fluoride Anti-Sensitivity Toothpaste For Dentin Hypersensitivity Management

This study will evaluate the impact of long-term use of a desensitizing toothpaste containing 0.454 percent (%) stannous fluoride (SnF2) on oral health related quality of life (OHrQoL) in a population of self-reported dentin hypersensitivity (DH) sufferers. Data generated will provide real world information on the DH experience and DH management with a daily use anti-sensitivity treatment.

Study Overview

• Status: Completed
• Conditions: Dentin Sensitivity
• Intervention / Treatment: Other: Stannous fluoride

Detailed Description

This will be a decentralized, prospective, 24-week, monadic design, open label, study in a DH population. The study will evaluate changes in OHrQoL in participants with self-reported DH symptoms over 24 weeks of use of a DH treatment (anti-sensitivity toothpaste). OHrQoL will be measured using a validated questionnaire, the Dentin Hypersensitivity Experience Questionnaire (DHEQ-48), completed by study participants at Baseline, and Weeks 4, 8, 12, 16, 20, 24.

• Study Type: Interventional
• Enrollment (Actual): 536
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10001
      • ObvioHealth Virtual Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participant who has provided consent indicating they have been informed of all pertinent aspects of the study.
• All genders who, at the time of screening, are aged between 18 and 65 years (inclusive).
• Participant who is willing to complete all the assigned activities.
• Participant who is able to independently complete all the assigned activities on their smart devices.
• Participant who has tooth sensitivity (self-reported symptoms).

Exclusion Criteria:

• Participant whose sensitivity could be caused by other factors or clinical pathology than DH, as self-reported on the screening questionnaire, which include:

  1. Participant who has been/is on multiple prescription medications to treat severe acid reflux on a regular basis or has had surgery for acid reflux.
  2. Participant with full or partial denture(s).
  3. Participant who has undergone treatment for periodontal or gum disease within 6 months of screening or is currently undergoing treatment for periodontal or gum disease.
  4. Participant who has been informed by a Dental Health Care Professional (DHCP) that they have active periodontitis.
  5. Participant who has been informed by a DHCP that they have active caries.
  6. Participant with any chronic and/or severe painful health condition(s) which lead to regular use of pain relief medications (more than 3 days a week).
• Participant with known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.

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: Anti-sensitivity toothpaste; Participants will use the anti-sensitivity toothpaste according to the instructions on the commercial pack and their normal oral healthcare habits for 24 weeks.	Other: Stannous fluoride; Anti-sensitivity toothpaste containing 0.454% Stannous Fluoride

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in DHEQ Total Score (Section 2, Question [Q]1-34) at Weeks 4, 8, 12, 16, 20 and 24	The DHEQ is a condition-specific measure of OHrQoL in relation to DH which contains total 34 questions in section 2, each with the scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranges from 34 to 238, where lower score indicates improvement in the symptoms. Change from Baseline is defined as score at indicated post-Baseline timepoint minus score at Baseline.	Baseline and Weeks 4, 8, 12, 16, 20, 24
Change from Baseline in DHEQ Restrictions Domain (Q1-4) Score at Weeks 4, 8, 12, 16, 20 and 24	Restrictions domain in DHEQ evaluates the ways in which any sensations in teeth affect participant's daily life. This contains 4 questions each with the scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranges from 4 to 28, where lower score indicates improvement in the symptoms. Change from Baseline is defined as score at indicated post-Baseline timepoint minus score at Baseline.	Baseline and Weeks 4, 8, 12, 16, 20, 24
Change from Baseline in DHEQ Adaptation Domain Score (Q5-16) at Weeks 4, 8, 12, 16, 20 and 24	Adaptation domain in DHEQ evaluates 'the ways in which the sensations in teeth have forced participants to change things in their daily life'; 'things they do in their daily life to avoid experiencing the sensations in their teeth'. This contains 12 questions each with the scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranges from 12 to 84, where lower score indicates improvement in the symptoms. Change from Baseline is defined as score at indicated post-Baseline timepoint minus score at Baseline.	Baseline and Weeks 4, 8, 12, 16, 20, 24
Change from Baseline in DHEQ Social Impact Domain (Q17-21) Score at Weeks 4, 8, 12, 16, 20 and 24	Social Impact domain in DHEQ evaluates the way the sensations affect participants when they are with other people or in certain situations. This contains 5 questions each with the scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranges from 5 to 35, where lower score indicates improvement in the symptoms. Change from Baseline is defined as score at indicated post-Baseline timepoint minus score at Baseline.	Baseline and Weeks 4, 8, 12, 16, 20, 24
Change from Baseline in DHEQ Emotional Impact Domain (Q22-29) Score at Weeks 4, 8, 12, 16, 20 and 24	Emotional Impact Domain in DHEQ evaluates the way the sensations in participant's teeth make them feel. This contains 8 questions each with the scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranges from 8 to 56, where lower score indicates improvement in the symptoms. Change from Baseline is defined as score at indicated post-Baseline timepoint minus score at Baseline.	Baseline and Weeks 4, 8, 12, 16, 20, 24
Change from Baseline in DHEQ Identity Domain (Q30-34) Score at Weeks 4, 8, 12, 16, 20 and 24	Identity Domain in DHEQ evaluates what the sensations in participant's teeth mean for them. This contains 5 questions each with the scale ranging from 1 (strongly disagree) to 7 (strongly agree). Thus, the total score ranges from 5 to 35, where lower score indicates improvement in the symptoms. Change from Baseline is defined as score at indicated post-Baseline timepoint minus score at Baseline.	Baseline and Weeks 4, 8, 12, 16, 20, 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Impact on Everyday Life (Section 1, Q1-3) at Weeks 4, 8, 12, 16, 20 and 24	DHEQ section 1 consist of 3 questions about teeth sensation and its impact on everyday life. Participants will score Q1 (how intense are the sensations?) on a scale of 1 (not at all intense) to 10 (worst imaginable); Q2 (how bothered are you by any sensations?) on a scale of 1 (not at all bothered) to 10 (extremely bothered); Q3 (how well can you tolerate sensations?) on a scale of 1 (can easily tolerate) to 10 (can't tolerate at all). The total score for each question ranging from 3 to 30; where lower score indicates less sensitivity and less impact on everyday life. Change from Baseline is defined as score at indicated post-Baseline timepoint minus score at Baseline.	Baseline and Weeks 4, 8, 12, 16, 20, 24
Change from Baseline in Global Oral Health (Section 2, Q35) Score at Weeks 4, 8, 12, 16, 20 and 24	Global Oral Health will be evaluated using a single question which asks about overall health of participant's mouth, teeth, and gums. The scale ranges from 1 (excellent) to 6 (Very poor), where lower score indicates improvement in the symptoms. Change from Baseline is defined as score at indicated post-Baseline timepoint minus score at Baseline.	Baseline and Weeks 4, 8, 12, 16, 20, 24
Change from Baseline in Effect on Life Overall (Section 2, Q36-39) Score at Weeks 4, 8, 12, 16, 20 and 24	Effect on Life will be evaluated using 4 questions which asks how much the sensations in teeth affect participant's life overall. The scale ranges from 0 (not at all) to 4 (Very much), where lower score indicates improvement in the symptoms. Change from Baseline is defined as score at indicated post-Baseline timepoint minus score at Baseline.	Baseline and Weeks 4, 8, 12, 16, 20, 24
Percentage of Participants who 'Agree' (Score 5-7) With Each Item (statement) in the 5 DHEQ Domains (Section 2, Q1-34) at Baseline and Week 24	The DHEQ consists of 5 domains namely- Restrictions, Adaptation, Social Impact, Emotional Impact and Identity with total 34 questions about the ways in which any sensations in teeth affect participants in their daily life. The scale ranges from 1(strongly disagree) to 7(strongly agree) and scores 5 to 7 indicates agreement with the statement mentioned in the question, where 5=Agree a little, 6=Agree and 7=Strongly agree.	Baseline and Week 24
Change from Baseline in Numeric Pain Rating Scale (NPRS) Score at Weeks 1, 2, 4, 8, 12, 16, 20 and 24	NPRS is the 11-point segmented numeric version of a Visual Analogue Scale from which the respondent selects the score (0-10) that best reflects the intensity of their pain, where 0=no pain and 10=worst possible pain. Higher scores are indicative of greater pain intensity. Change from Baseline is defined as score at indicated post-Baseline timepoint minus score at Baseline.	Baseline and Weeks 1, 2, 4, 8, 12, 16, 20, 24
Satisfaction Numeric Rating Scale (NRS) Score at Week 24	Participants will rate their satisfaction with the DH treatment using NRS. It is an 11-point ordinal scale used to assess satisfaction with the overall management of the condition for which the individual sought help from treatment. It ranges from 0 (completely dissatisfied) to 10 (completely satisfied), with higher scores indicative of greater satisfaction.	Week 24
Oral Hygiene Questionnaire (OHQ) Responses at Baseline	Participants will describe their oral hygiene habits at Baseline by completion of an OHQ.	Baseline

Collaborators and Investigators

• Sponsor: HALEON

Study record dates

Study Major Dates

• Study Start (Actual): September 21, 2023
• Primary Completion (Actual): April 25, 2024
• Study Completion (Actual): April 25, 2024

Study Registration Dates

• First Submitted: September 13, 2023
• First Submitted That Met QC Criteria: September 13, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2024
• Last Update Submitted That Met QC Criteria: April 30, 2024
• Last Verified: April 1, 2024

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; Protective Agents; Cariostatic Agents; Fluorides; Tin Fluorides
• Other Study ID Numbers: 300058

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual participant data and study documents can be requested for further research from ww.clinical-trial-register@haleon.com
• IPD Sharing Time Frame: IPD will be made available within 6 months of publishing the results of the primary endpoints, 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No