A Test on a New Experimental Mouth Rinse for Relieving Tooth Sensitivity

NCT01727258 | Completed Results

• 1 other identifier: KOXDHY0008
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

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 subjects, and check for sensitive teeth. During the first 2 weeks, participants will brush their teeth two times a day with the fluoride toothpaste provided. Then, if they qualify to continue in the study, participants will be assigned to a treatment group. All the groups will get toothpaste currently sold on the market, and one group will get a mouthwash with an experimental ingredient to use as well. Subjects will have an equal chance of being assigned to any one of the three groups. For the next 4 weeks, subjects will use their assigned products according to the directions provided. At Visit 1 subjects will be supervised while they brush their teeth to ensure they understand the directions. They will also have supervised use of the product at Visit 2. We will see if the mouthwash helps to reduce tooth sensitivity during the study.

Conditions

Dentin Sensitivity

Keywords

Tooth Sensitivity

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  2 weeks

Secondary Outcomes (4)

• Mean Tactile Sensitivity VAS Score at Week 2

  2 weeks

• Mean Tactile Sensitivity VAS Score at Week 4

  4 weeks

• Mean Cold Air Stimulus VAS Score at Week 2

  2 weeks

• Mean Cold Air Stimulus VAS Score at Week 4

  4 weeks

Study Arms (3)

Mouth Rinse

EXPERIMENTAL

Twice daily for 28 days, brush in usual manner for at least one minute using at least a one-inch strip of Fluoride Toothpaste provided. Rinse with water after brushing teeth. Then rinse for 60 seconds with 10 mL of the experimental Mouth Rinse 12027-033 (KOX).

Device: Mouth Rinse; Drug: Fluoride Toothpaste

Fluoride Toothpaste

ACTIVE COMPARATOR

Twice daily for 28 days, brush in usual manner for at least one minute using at least a one-inch strip of the Fluoride Toothpaste (NEG) provided.

Drug: Fluoride Toothpaste

Potassium Nitrate Toothpaste

ACTIVE COMPARATOR

Twice daily for 28 days, brush in usual manner for at least one minute using at least a one-inch strip of the Potassium Nitrate Toothpaste (POS) provided.

Drug: Potassium Nitrate Toothpaste

Interventions

Mouth Rinse DEVICE

Mouth rinse 12027-033 used twice daily for 28 days after brushing.

Mouth Rinse

Fluoride Toothpaste DRUG

Fluoride Toothpaste used daily for 28 days.

Also known as: Colgate® Cavity Protection Regular

Fluoride Toothpaste; Mouth Rinse

Potassium Nitrate Toothpaste DRUG

Potassium Nitrate Toothpaste used daily for 28 days.

Also known as: Sensodyne® Original

Potassium Nitrate Toothpaste

Eligibility Criteria

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

You may qualify if:

• 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
• Adequate oral hygiene (i.e. brush teeth daily and exhibit no signs of oral neglect

You may not qualify if:

• Medical condition or history, or use of drugs or treatments that could possibly compromise the safety of the research subject or the interpretation of results, per protocol or in the opinion of the investigator
• Use of home-care bleaching, whitening products or professional bleaching treatment within a protocol-specified time period
• Use of desensitizing agents within a protocol-specified time period
• Participation in a dental clinical trial involving oral care products within a protocol-specified time period

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

• Michael Lynch, DMD, PhD

  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: SINGLE
• Who Masked: INVESTIGATOR
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2012
• First Posted: November 15, 2012
• Study Start: December 1, 2012
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: June 10, 2015
• Results First Posted: June 10, 2015

Record last verified: 2015-04

Locations

US (1)