Clinical trial NCT01133379: Tooth Sensitivity Relief by Two Mouthrinses
Official title: Evaluation of the Efficacy of Two Potassium Oxalate Containing Mouthrinses for Relieving Dentinal Hypersensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentin Sensitivity
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2010-05-28
Enrollment: 174
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study is for people with sensitive teeth and involves going to the dentist for 6 visits over 8 weeks. During the first 2 weeks, everyone will just brush their teeth two times a day with the fluoride toothpaste provided.

Then you will be assigned to a mouthwash group if you qualify to continue in the study. Two groups will get mouthwash with a certain amount of an experimental ingredient and one group will get a mouthwash with no experimental ingredients. You will have an equal chance of being assigned to any one of the three groups.

For the next 6 weeks, you will rinse with your assigned mouthwash after brushing. A dentist will look at your mouth, teeth, tongue and gums and check for sensitive teeth. The investigators will see if the mouthwash helps to reduce tooth sensitivity during the study.

Detailed description: This is a double-blind, randomized, parallel group, single center, controlled clinical trial design. Approximately 200 generally healthy adults meeting the necessary inclusion/exclusion criteria will be enrolled so that 180 subjects (60 per treatment group) would reasonably be expected to complete the study. Subjects will have their oral soft/hard tissues assessed and will be evaluated for sensitivity levels at Screening (visit 1), Baseline (visit 2), Week 1, Week 2, Week 4 \& Week 6. During the first two weeks of the study, subjects will be instructed to brush their teeth for one minute in their usual manner, twice daily using the provided standard fluoride toothpaste. Subjects will return for the Baseline exam and, upon qualification with entry criteria, will be assigned to one of three treatment groups. Qualified subjects will be instructed to brush their teeth two times daily for one minute in their usual manner using the provided standard fluoride toothpaste. Subjects will be instructed to rinse twice daily, after brushing, with the provided mouthrinse for 60 seconds using 10 ml or 20 ml (depending on the treatment group), for 6 consecutive weeks.

Eligibility criteria: Inclusion Criteria:

* Males and females at least 18 years of age in good general and oral health without any known allergy to commercial dental products or cosmetics.
* Evidence of a personally signed and dated informed consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial
* Willingness to use the assigned products according to instructions, availability for appointments, and likelihood of completing the clinical trial.
* A minimum of 2 natural premolars, canines, and/or incisors teeth with decay-free scorable facial/buccal surfaces which must present cervical abrasion, and/or erosion and/or gingival recession.
* A minimum of two eligible teeth (premolars, canines and/or incisors) with a Screening (-2 weeks Baseline) and Baseline tactile sensitivity score between 10 - 50 grams after application of the Yeaple probe and a cold air stimulus VAS score of 30 - 80 mm on a 100 mm VAS scale will be followed as study teeth during the trial.
* No more than two eligible teeth per quadrant each separated by 2 other teeth must be selected.Absence of significant oral soft tissue pathology, based on the dentist's visual examination and at the discretion of the investigator.
* Adequate oral hygiene (i.e. brush teeth daily and exhibit no signs of oral neglect).
* Absence of severe marginal gingivitis, moderate/advanced periodontitis (ADA Type III, IV) based on a clinical examination and discretion of the Investigator.
* Absence of extensive supragingival calculus.

Exclusion Criteria:

* Volunteers who report history or presence of kidney disorders, kidney stones, eating disorders, uncontrolled GERD, excessive dietary or environmental exposure to acids, or other systemic conditions that are predisposing to dentinal hypersensitivity.
* Volunteers with chronic medical debilitating disease associated with constant or intermittent episodes of daily pain.
* Long-term daily use (≥ 7 consecutive days) of analgesics and any other drugs that at the discretion of the Investigator would compromise the response of the hypersensitivity assessments.
* Volunteers who have been using any home-care bleaching, whitening products or have had a professional bleaching treatment within 4 weeks of the Screening visit.
* Use of desensitizing agents whether prescribed or over-the-counter within eight weeks prior to screening visit (any sensitivity toothpastes such as Crest Sensitivity, Sensodyne, Crest Pro-Health, Colgate Sensitivity Relief, any mouthwash and oral care products used for the treatment of dentinal hypersensitivity).
* Volunteers who during the study will receive dental treatment which may affect their dentinal hypersensitivity condition (i.e. oral prophylaxis). Emergency treatment will be allowed.
* Those requiring antibiotic premedication prior to invasive dental procedures.
* Participation in a dental clinical trial involving oral care products within the past 30 days.
* Women who are pregnant, nursing or plan to become pregnant during the course of the study.
* Teeth that are grossly carious, orthodontically banded, abutment teeth for fixed or removable prostheses, crowned teeth, or third molars will not be included in the study.
* Periodontal surgery and orthodontic treatment within previous 3 months.
* Extensive restorative treatment (i.e. extensively restored teeth or teeth with restoration(s) extending into the test area) at the discretion of the Investigator.
* Dental prophylaxis within 2 weeks prior to Screening visit.
* Teeth or periodontium with pathology or defect likely to cause pain.
* Teeth with clinical mobility \> grade 1.

Primary outcomes:
measure: Mean Tactile Sensitivity Score at Week 6
timeFrame: 6 Weeks
measure: Mean Tactile Sensitivity Score at Week 4
timeFrame: 4 Weeks
measure: Mean Tactile Sensitivity Score at Week 2
timeFrame: 2 Weeks
measure: Mean Tactile Sensitivity Score at Week 1
timeFrame: 1 Week
Secondary outcomes:
measure: Mean Tactile Sensitivity VAS Score at Week 1
timeFrame: 1 Week
measure: Mean Tactile Sensitivity VAS Score at Week 2
timeFrame: 2 Weeks
measure: Mean Tactile Sensitivity VAS Score at Week 4
timeFrame: 4 Weeks
measure: Mean Tactile Sensitivity VAS Score at Week 6
timeFrame: 6 Weeks
measure: Mean Cold Air Stimulus VAS Score at Week 1
timeFrame: 1 Week
measure: Mean Cold Air Stimulus VAS Score at Week 2
timeFrame: 2 Weeks
measure: Mean Cold Air Stimulus VAS Score at Week 4
timeFrame: 4 Weeks
measure: Mean Cold Air Stimulus VAS Score at Week 6
timeFrame: 6 Weeks
measure: Global Subjective VAS Score at Week 1
timeFrame: 1 Week
measure: Global Subjective VAS Score at Week 2
timeFrame: 2 Weeks
measure: Global Subjective VAS Score at Week 4
timeFrame: 4 Weeks
measure: Global Subjective VAS Score at Week 6
timeFrame: 6 Weeks
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: BioSci Research America, Inc.
state: Nevada
Study officials:
affiliation: Johnson & Johnson Consumer and Personal Products Worldwide
name: Angela Hee
role: STUDY_DIRECTOR
References: