Clinical trial NCT02113579: Test on a New Experimental Mouth Rinse for Relieving Tooth Sensitivity
Official title: Assessment of a Potassium Oxalate Containing Formulation for the Relief of Dentinal Hypersensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentin Sensitivity
Keywords: Tooth Sensitivity
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2014-04-14
Enrollment: 375
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is for people with sensitive teeth and involves going to the dentist for 4 visits over 6 weeks. At each visit the dentist will look at the mouth, teeth, tongue and gums of participants, and check for sensitive teeth.

During the first 2 weeks, participants will brush their teeth 2 times a day with the fluoride toothpaste provided.

Then, if they qualify to continue in the study, participants will be assigned to one of two treatment groups for the last 4 weeks. Both groups will use assigned toothpaste currently sold on the market. Both groups will each have an investigative mouth rinse to use as well. Participants will have an equal chance of being assigned to any one of the three groups.

For the next 4 weeks, participants will use their assigned products according to the directions provided. At Visit 1, participants will be supervised while they brush their teeth to ensure they understand the directions. They will also have supervised use of the products at Visit 2.

Results will be analyzed to assess whether the mouthwashes help to reduce tooth sensitivity during the study.

Detailed description: This study will consist of run-in and treatment phases. To qualify for the study, participants must meet the inclusion/exclusion criteria and return tactile sensitivity scores within protocol-specified parameters at both the screening and baseline visits.

Run-in will consist of a 2-week period during which participants will use a sodium fluoride dentifrice. At the start of the first phase, participants will attend a Screening Visit. They will participate in the informed consent process, complete a medical/dental history, and be evaluated for tactile sensitivity to Yeaple probe and response to a cold air stimulus.

Participants who qualify through screening will begin a run-in period that will last approximately two weeks. The run-in period will be followed by a Baseline visit. Participants who continue to qualify through Baseline will be randomly assigned to one of two treatment groups.

During the four-week treatment period, all participants will brush their teeth twice daily for at least one minute in their usual manner, with their assigned toothpaste. After brushing, participants will rinse with water, and then rinse with 10 mL of their assigned experimental mouth rinse for 60 seconds.

The study duration is approximately six weeks with each participant visiting the clinical site four times.

Adverse events will be observed and collected by querying each participant at each visit for new or continuing symptoms.

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 study
* Females of childbearing potential must be using a medically-acceptable method of birth control for at least one month prior to Visit 1 and agree to continue using this method during their participation in the study. Acceptable methods for this study include:
* Abstinence
* Birth control pills, patches, vaginal rings, implants or injections
* Intrauterine device
* Double barrier method (condom/diaphragm or cervical cap with spermicide)
* Bilateral tubal ligation
* Hysterectomy
* Ovariectomy
* Male partner vasectomy
* Willingness to use the assigned products according to instructions, availability for appointments, and likelihood of completing the clinical study.
* 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 cold air stimulus Visual Analogue Scale (VAS) score of 40 - 80 mm on a 100 mm VAS scale, tactile sensitivity score between 10 - 30 grams after application of the Yeaple probe and a tactile (Yeaple probe) VAS of 40 -80 mm on a 100 mm VAS scale.
* 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 absence of extensive calculus above the gum line.

Exclusion Criteria:

* Volunteers who report 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.
* Volunteers with 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.
* 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 with a known allergy to study products' ingredients.
* Those requiring antibiotic premedication prior to invasive dental procedures.
* Participation in a dental clinical study involving oral care products within the past 30 days.
* Self reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study results)
* 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.
* Relative, partner or staff of any clinical research site personnel
* Participation in any clinical study within 30 days of Visit 1.

Primary outcomes:
measure: Percentage of Subjects With Reduction From Baseline by at Least 30% in Mean Cold Air VAS Stimulus Score at Week 4
timeFrame: 4 Weeks
Secondary outcomes:
measure: Mean Cold Air Stimulus VAS Score at Week 4
timeFrame: 4 Weeks
measure: Mean Tactile Sensitivity Score at Week 4
timeFrame: 4 Weeks
measure: Mean Cold Air Stimulus VAS Score at Week 2
timeFrame: 2 Weeks
measure: Mean Tactile Sensitivity Score at Week 2
timeFrame: 2 Weeks
measure: Percentage of Subjects With Reduction From Baseline by at Least 30% in Mean Cold Air VAS Stimulus Score at Week 2
timeFrame: 2 Weeks
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: Global Subjective VAS Score at Week 2
timeFrame: 2 Weeks
measure: Global Subjective VAS Score at Week 4
timeFrame: 4 Weeks
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: Salus Research, Inc.
state: Indiana
city: Las Vegas
country: United States
facility: Silverstone
state: Nevada
Study officials:
affiliation: Johnson & Johnson Consumer and Personal Products Worldwide
name: Michael Lynch
role: STUDY_DIRECTOR
References: