Tooth Sensitivity Relief by Two Mouthrinses

NCT01133379 | Completed Results

• 1 other identifier: KOXDHY0001
• Study Type: interventional
• Target: 174
• Locations: 1 country
• Sites: 1

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.

Conditions

Dentin Sensitivity

Outcome Measures

Primary Outcomes (4)

• Mean Tactile Sensitivity Score at Week 6

  Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit.

  6 Weeks

• Mean Tactile Sensitivity Score at Week 4

  Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit.

  4 Weeks

• Mean Tactile Sensitivity Score at Week 2

  Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit.

  2 Weeks

• Mean Tactile Sensitivity Score at Week 1

  Tooth sensitivity was measured using a Yeaple probe. The force at which discomfort was felt by the participant was recorded on a scale of 10-80 grams. The score for each participant was calculated by averaging the scores for all study teeth for that participant, at each visit.

  1 Week

Secondary Outcomes (12)

• Mean Tactile Sensitivity VAS Score at Week 1

  1 Week

• Mean Tactile Sensitivity VAS Score at Week 2

  2 Weeks

• Mean Tactile Sensitivity VAS Score at Week 4

  4 Weeks

• Mean Tactile Sensitivity VAS Score at Week 6

  6 Weeks

• Mean Cold Air Stimulus VAS Score at Week 1

  1 Week

Study Arms (3)

PO-019

EXPERIMENTAL

1.40% Potassium Oxalate Sensitive Mouthwash without fluoride (12027-019)

Device: 12027-019

PO-020

EXPERIMENTAL

1.40% Potassium Oxalate Sensitive Mouthwash with fluoride (12027-020)

Device: 12027-020

PO-021

SHAM COMPARATOR

Vehicle Control Mouthrinse (without potassium oxalate and without fluoride) (12027-021)

Device: 12027-021

Interventions

12027-019 DEVICE

Rinse with 10 mL for 60 seconds twice daily after brushing in your usual manner for 1 minute using at least a one-inch strip of the assigned toothpaste.

Also known as: 1.40% Potassium Oxalate Sensitive Mouthwash without fluoride

PO-019

12027-020 DEVICE

Rinse with 20 mL for 60 seconds twice daily after brushing in your usual manner for 1 minute using at least a one-inch strip of the assigned toothpaste.

Also known as: 1.40% Potassium Oxalate Sensitive Mouthwash with fluoride

PO-020

12027-021 DEVICE

Rinse with 10 mL for 60 seconds twice daily after brushing in your usual manner for 1 minute using at least a one-inch strip of the assigned toothpaste

Also known as: Vehicle Control Mouthrinse

PO-021

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 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Consumer and Personal Products Worldwide: lead

Study Sites (1)

BioSci Research America, Inc.

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

• Angela Hee

  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, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2010
• First Posted: May 28, 2010
• Study Start: May 1, 2010
• Primary Completion: July 1, 2010
• Study Completion: July 1, 2010
• Last Updated: July 9, 2015
• Results First Posted: July 9, 2015

Record last verified: 2015-06

Locations

US (1)