Test on a New Experimental Mouth Rinse for Relieving Tooth Sensitivity

NCT02113579 | Completed Results

• 1 other identifier: KOXDHY0009
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 2

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.

Conditions

Dentin Sensitivity

Keywords

Tooth Sensitivity

Outcome Measures

Primary Outcomes (1)

• Percentage of Subjects With Reduction From Baseline by at Least 30% in Mean Cold Air VAS Stimulus Score at Week 4

  Tooth sensitivity was measured using a Cold Air Stimulus. When being assessed, participants rated their perception of the pain/discomfort experienced when cold air was directed at the exposed root of each tooth by marking a single vertical line on a Visual Analogue Scale (VAS) scale from 0 to 100 mm, where 0 = No Pain/Discomfort and 100 = Intense Pain/Discomfort. The dental recorder measured the length of the line from 0 to the participant's line and recorded the VAS score in mm. The score for each participant was calculated by averaging the scores for all study teeth for that participant. A participant was considered an individual success if the participant's mean cold air stimulus VAS score at Week 4 was at least 30% lower than the participant's mean baseline cold air stimulus VAS score.

  4 Weeks

Secondary Outcomes (9)

• Mean Cold Air Stimulus VAS Score at Week 4

  4 Weeks

• Mean Tactile Sensitivity Score at Week 4

  4 Weeks

• Mean Cold Air Stimulus VAS Score at Week 2

  2 Weeks

• Mean Tactile Sensitivity Score at Week 2

  2 Weeks

• Percentage of Subjects With Reduction From Baseline by at Least 30% in Mean Cold Air VAS Stimulus Score at Week 2

  2 Weeks

Study Arms (2)

KOX

EXPERIMENTAL

After brushing for at least one-minute using at least one-inch strip of toothpaste, rinse with water and then rinse 60 seconds with 10mL of mouth rinse, twice daily. Fluoride Toothpaste / Crest® Cavity Protection Regular and Experimental Mouth Rinse 12027-033

Device: Experimental Mouth Rinse 12027-033

PLA

PLACEBO COMPARATOR

After brushing for at least one-minute using at least one-inch strip of toothpaste, rinse with water and then rinse 60 seconds with 10mL of mouth rinse, twice daily. Fluoride Toothpaste/Crest® Cavity Protection Regular and Placebo Mouth Rinse

Other: Placebo Mouth Rinse

Interventions

Experimental Mouth Rinse 12027-033 DEVICE

After brushing for at least one-minute using at least one-inch strip of toothpaste, rinse with water and then rinse 60 seconds with 10mL of mouth rinse, twice daily.

Also known as: Fluoride Toothpaste / Crest® Cavity Protection Regular

KOX

Placebo Mouth Rinse OTHER

After brushing for at least one-minute using at least one-inch strip of toothpaste, rinse with water and then rinse 60 seconds with 10mL of mouth rinse, twice daily.

Also known as: Fluoride Toothpaste/Crest® Cavity Protection Regular

PLA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Consumer and Personal Products Worldwide: lead

Study Sites (2)

Salus Research, Inc.

Fort Wayne, Indiana, 46825, United States

Location

Silverstone

Las Vegas, Nevada, 89121, United States

Location

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Michael Lynch, DMD, PhD/Study Director
• Organization: Johnson & Johnson Consumer and Personal Products Worldwide

mlynch23@its.jnj.com

908-433-6423 USA EST

Study Officials

• Michael Lynch

  Johnson & Johnson Consumer and Personal Products Worldwide

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2014
• First Posted: April 14, 2014
• Study Start: March 1, 2014
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: June 10, 2015
• Results First Posted: June 10, 2015

Record last verified: 2015-05

Locations

US (2)