Tooth Sensitivity Relief by Two Mouthrinses

NCT ID: NCT01133379

Last Updated: 2015-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 174 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2010-07-31

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.

Conditions

Dentin Sensitivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

PO-019

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

Group Type: EXPERIMENTAL

12027-019

Intervention Type: 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.

PO-020

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

Group Type: EXPERIMENTAL

12027-020

Intervention Type: 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.

PO-021

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

Group Type: SHAM_COMPARATOR

12027-021

Intervention Type: 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

Interventions

12027-019

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.

Intervention Type: DEVICE

12027-020

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.

Intervention Type: DEVICE

12027-021

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

Intervention Type: DEVICE

Other Intervention Names

1.40% Potassium Oxalate Sensitive Mouthwash without fluoride; 1.40% Potassium Oxalate Sensitive Mouthwash with fluoride; Vehicle Control Mouthrinse

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Consumer and Personal Products Worldwide

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Angela Hee

Role: STUDY_DIRECTOR

Johnson & Johnson Consumer and Personal Products Worldwide

Locations

BioSci Research America, Inc.

Las Vegas, Nevada, United States

Countries

United States

Other Identifiers

KOXDHY0001

Identifier Type: -

Identifier Source: org_study_id