- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03965039
A Clinical Study to Assess the Effects of Various Dentifrice Technologies on Dentinal Hypersensitivity
October 26, 2020 updated by: Procter and Gamble
A Randomized Clinical Study to Assess the Effects of Various Dentifrice Technologies on Dentinal Hypersensitivity
The objective of this study is to evaluate the efficacy (changes in dentinal hypersensitivity) and safety (oral soft tissue evaluation) after use of one of four dentifrices in subjects with pre-existing hypersensitivity over an 11-week period.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nevada
-
Las Vegas, Nevada, United States, 89146
- Silverstone Research Group
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- be at least 18 years of age;
- provide written informed consent prior to participation and be given a signed copy of the informed consent form;
- sign a Confidentiality Disclosure Agreement (CDA);
- be in good general health as determined by the Investigator/designee;
- agree not to participate in any other oral/dental product studies during the course of this study;
- agree to delay any dentistry (including dental prophylaxis) until the study has been completed;
- agree to refrain from the use of any non-study oral hygiene products*;
- exhibit adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect);
- have an absence of extensive calculus above the gum line;
- agree to return for all scheduled visits and follow study procedures; and
- have two teeth with a Schiff sensitivity score > 1 in response to air challenge and a Yeaple probe score of 10-20 g in response to tactile challenge. (If these two eligible teeth are located in the same quadrant, they have to be separated by 2 other teeth.)
Exclusion Criteria:
- having taken anti-inflammatory, analgesic, or psychotropic drugs, chronically;
- chronic medical debilitating disease associated with constant or intermittent episodes of daily pain;
- any home-care bleaching, whitening products or have had a professional bleaching treatment within 4 weeks of the Baseline visit;
- dental prophylaxis within 2 weeks prior to Baseline visit;
- having received professional desensitizing treatment or having used over-the-counter desensitizing products within 6 weeks of the Baseline visit;
- having periodontal surgery, orthodontic treatment, or teeth restored in the preceding three months;
- having teeth or periodontium with pathology or defects likely to cause pain;
- having a history of allergies or hypersensitivity to ingredients in commercial dental products or cosmetics;
- self-reported pregnancy or lactation;
- having self-reported eating disorders, uncontrolled gastroesophageal reflux disease (GERD or Acid Reflux), excessive dietary or environmental exposure to acids, or other systemic conditions that are predisposing to dentinal hypersensitivity;
- history or presence of kidney disorders, kidney stones, have celiac disease, inflammatory bowel disease (ulcerative colitis or Crohn's disease), chronic pancreatitis, have had intestinal or weight-loss surgery, or if have stomach or intestinal problems that keep them from absorbing certain foods or nutrients;
- any diseases or condition that might interfere with the safe participation in the study;
- inability to undergo study procedures;
- having severe xerostomia;
- having had active caries within the 12 months;
- having high risk for caries development (rampant caries, multiple dental restorations, crowns with compromised margin) per examiners discretion;
teeth will be excluded from study measurements if they:
- have deep, defective, or facial restorations;
- have full crowns, extensive caries, cracked enamel, or are abutment teeth for fixed or removable prosthesis;
- present with tendency for spontaneous bleeding;
- have been scaled/root planed or restored within the past 3 months.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Marketed stannous fluoride toothpaste
Brush twice daily
|
Marketed stannous fluoride (0.454%) toothpaste
|
Active Comparator: Marketed potassium nitrate toothpaste
Brush Twice Daily
|
Marketed potassium nitrate (5%) toothpaste
|
Placebo Comparator: Marketed sodium monofluorophosphate toothpaste
Brush Twice Daily
|
Marketed sodium monofluorophosphate (0.76%) toothpaste
|
Experimental: Experimental dipotassium oxalate toothpaste
Brush Twice Daily
|
Experimental dipotassium oxalate (3%) toothpaste
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Air Challenge
Time Frame: 4 weeks
|
The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge.
The examiner will record the Schiff Index score corresponding to the response to the air challenge.
The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
The higher the Schiff score, the more sensitive the tooth.
The least square mean will be calculated for this measure.
|
4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Baseline Air Challenge
Time Frame: Baseline
|
The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge.
The examiner will record the Schiff Index score corresponding to the response to the air challenge.
The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
The higher the Schiff score, the more sensitive the tooth.
|
Baseline
|
Air Challenge
Time Frame: 3 days
|
The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge.
The examiner will record the Schiff Index score corresponding to the response to the air challenge.
The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
The higher the Schiff score, the more sensitive the tooth.
The least square mean will be calculated for this measure.
|
3 days
|
Air Challenge
Time Frame: 2 weeks
|
The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge.
The examiner will record the Schiff Index score corresponding to the response to the air challenge.
The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
The higher the Schiff score, the more sensitive the tooth.
The least square mean will be calculated for this measure.
|
2 weeks
|
Air Challenge
Time Frame: 8 weeks
|
The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge.
The examiner will record the Schiff Index score corresponding to the response to the air challenge.
The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
The higher the Schiff score, the more sensitive the tooth.
The least square mean will be calculated for this measure.
|
8 weeks
|
Air Challenge
Time Frame: 11 weeks
|
The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge.
The examiner will record the Schiff Index score corresponding to the response to the air challenge.
The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
The higher the Schiff score, the more sensitive the tooth.
The least square mean will be calculated for this measure.
All subjects will have been on three weeks use of a marketed sodium monofluophosphate toothpaste (from week 8 to week 11).
|
11 weeks
|
Baseline Yeaple Probe
Time Frame: Baseline
|
Tactile Threshold will be measured using a Yeaple probe.
Testing is performed beginning at 10 g.
The examiner records tactile scores for responding teeth.
After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g.
The higher the tactile threshold, the less sensitive the tooth.
Each successive challenge increases until a "yes" response is repeated.
If a second "yes" is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive "yes" responses and will be recorded as the threshold on the Tactile Sensitivity Score form.
|
Baseline
|
Tactile Threshold
Time Frame: 3 days
|
Tactile Threshold will be measured using a Yeaple probe.
Testing is performed beginning at 10 g.
The examiner records tactile scores for responding teeth.
After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g.
The higher the tactile threshold, the less sensitive the tooth.
Each successive challenge increases until a "yes" response is repeated.
If a second "yes" is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive "yes" responses and will be recorded as the threshold on the Tactile Sensitivity Score form.
The least square mean will be calculated for this measure.
|
3 days
|
Tactile Threshold
Time Frame: 2 weeks
|
Tactile Threshold will be measured using a Yeaple probe.
Testing is performed beginning at 10 g.
The examiner records tactile scores for responding teeth.
After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g.
The higher the tactile threshold, the less sensitive the tooth.
Each successive challenge increases until a "yes" response is repeated.
If a second "yes" is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive "yes" responses and will be recorded as the threshold on the Tactile Sensitivity Score form.
The least square mean will be calculated for this measure.
|
2 weeks
|
Tactile Threshold
Time Frame: 4 weeks
|
Tactile Threshold will be measured using a Yeaple probe.
Testing is performed beginning at 10 g.
The examiner records tactile scores for responding teeth.
After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g.
The higher the tactile threshold, the less sensitive the tooth.
Each successive challenge increases until a "yes" response is repeated.
If a second "yes" is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive "yes" responses and will be recorded as the threshold on the Tactile Sensitivity Score form.
The least square mean will be calculated for this measure.
|
4 weeks
|
Tactile Threshold
Time Frame: 8 weeks
|
Tactile Threshold will be measured using a Yeaple probe.
Testing is performed beginning at 10 g.
The examiner records tactile scores for responding teeth.
After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g.
The higher the tactile threshold, the less sensitive the tooth.
Each successive challenge increases until a "yes" response is repeated.
If a second "yes" is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive "yes" responses and will be recorded as the threshold on the Tactile Sensitivity Score form.
The least square mean will be calculated for this measure.
|
8 weeks
|
Tactile Threshold
Time Frame: 11 weeks
|
Tactile Threshold will be measured using a Yeaple probe.
Testing is performed beginning at 10 g.
The examiner records tactile scores for responding teeth.
After treatment, testing begins at 10 g and increases by 10 g to a maximum of 50 g.
The higher the tactile threshold, the less sensitive the tooth.
Each successive challenge increases until a "yes" response is repeated.
If a second "yes" is not obtained, the force setting is increased to the next step and continued until a force is found which elicits two consecutive "yes" responses and will be recorded as the threshold on the Tactile Sensitivity Score form.
The least square mean will be calculated for this measure.
All subjects will have been on three weeks use of a marketed sodium monofluorophosphate toothpaste (from week 8 to week 11).
|
11 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 8, 2019
Primary Completion (Actual)
October 3, 2019
Study Completion (Actual)
October 3, 2019
Study Registration Dates
First Submitted
May 23, 2019
First Submitted That Met QC Criteria
May 23, 2019
First Posted (Actual)
May 28, 2019
Study Record Updates
Last Update Posted (Actual)
October 30, 2020
Last Update Submitted That Met QC Criteria
October 26, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019079
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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