Study of an Experimental Toothbrush for Treatment and Prevention of Gingivitis

NCT01224158 | Completed Results FDA Device

• 1 other identifier: TBRGBP0016
• Study Type: interventional
• Target: 153
• Locations: 1 country
• Sites: 1

Brief Summary

This study is 6 weeks long with 6 visits to a clinical site. People participating in this study will be asked to brush their teeth two times a day with a provided toothbrush. For one of those six weeks people will be asked to rinse with a mouthwash. During that time, people will use the mouthwash two times a day and will not be allowed to brush their teeth at all. The mouth, teeth, tongue and gums will be looked at by a dentist. At each visit, people will rinse with a pink liquid that will dye their mouths pink. The dye is temporary and will go away by the end of the day. They may also be asked to complete a short questionnaire about their experience.

Conditions

Dental Devices, Home Care

Outcome Measures

Primary Outcomes (1)

• Whole-mouth Mean Modified Gingival Index (MGI) Score at Day 42

  Gingivitis was assessed by the Modified Gingival Index on the buccal and lingual marginal gingiva and interdental papillae of all scorable teeth by the dental examiner using following scale score range from 0 to 4, where 0 - Normal (absence of inflammation); 1 - Mild inflammation (slight change in color, little change in texture) of any portion of the gingival unit; 2 - Mild inflammation of the entire gingival unit; 3 - Moderate inflammation (moderate glazing, redness, edema, and/or hypertrophy) of the gingival unit; 4 - Severe inflammation (marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration) of the gingival unit.

  Day 42

Secondary Outcomes (5)

• Whole-mouth Mean Modified Gingival Index (MGI) Score at Day 28

  Day 28

• Whole-mouth Mean Rustogi Modified Navy Plaque Index (RMNPI) Score at Day 42

  Day 42

• Whole-Mouth Mean Rustogi Modified Navy Plaque Index (RMNPI) Score at Day 28

  Day 28

• Hard-to-reach Mean Rustogi Modified Navy Plaque Index (RMNPI) at Day 28 and 42

  Day 28 and 42

• Mean Rustogi Modified Navy Plaque Index (RMNPI) at Day 28 and 42 for Each Hard-to-reach Area

  Day 28 and 42

Study Arms (2)

PR-009577 Toothbrush

EXPERIMENTAL

Experimental Power Toothbrush

Device: Experimental Power Toothbrush

PR-000172 Toothbrush

ACTIVE COMPARATOR

Flat trimmed Manual Toothbrush

Device: Flat trimmed Manual Toothbrush

Interventions

Experimental Power Toothbrush DEVICE

Following a placebo mouthwash phase, Subjects will be asked to brush their teeth (twice per day with the experimental toothbrush and toothpaste provided) moving to the next quadrant of the mouth at 30-second intervals.

Also known as: Not yet marketed

PR-009577 Toothbrush

Flat trimmed Manual Toothbrush DEVICE

Following a placebo mouthwash phase, Subjects will be asked to brush their teeth (twice per day using the toothbrush and toothpaste provided) in their usual manner.

Also known as: Reach®

PR-000172 Toothbrush

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females at least 18 years of age and in good general and oral health.
• 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.
• Good general and oral health with manual dexterity.
• Willingness to refrain from all oral hygiene procedures within 18-24 hours prior to the study visit.
• A minimum of twenty scorable teeth with at least one scorable molar in each quadrant.
• A whole-mouth mean plaque level greater than 0.60 at Day 0.
• Whole-mouth-mean gingivitis level greater than or equal to 1.75 at Day 0.
• Absence of orthodontic bands, appliances, bridges, numerous crowns, extensive large restorations, excessive caries, removable orthodontic appliances or partial dentures.
• Absence of significant oral soft tissue pathology, excluding gingivitis, based on the visual oral examination and at the discretion of the examiner.
• Adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect).
• Absence of moderate/advanced periodontitis.
• Absence of extensive supragingival calculus.
• Absence of ulcerations on lips and oral mucosa.

You may not qualify if:

• Currently taking steroids, antibiotic medication or any other medication within the previous month that may interfere with the efficacy evaluations.
• Those requiring antibiotic premedication prior to dental treatment.
• Participation in a dental clinical trial involving oral care products currently or within the past 28 days.
• Dental prophylaxis within one week prior to enrollment into the study.
• Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the subject inappropriate for entry into this trial.
• Physical limitations or restrictions that might preclude use of normal oral hygiene procedures (i.e., toothbrushing, etc.).
• Self-reported pregnant or lactating women.

Sponsors & Collaborators

• Johnson & Johnson Consumer and Personal Products Worldwide: lead

Study Sites (1)

BioSci Research America

Las Vegas, Nevada, 89121, United States

Location

Limitations and Caveats

No study limitations were reported.

Results Point of Contact

• Title: Director Oral Health, Medical Affair & Clinical Research
• Organization: Johnson & Johnson Consumer and Personal Products Worldwide

ClinicalTrialDisclosure@its.jnj.com

844-434-4210

Study Officials

• Marcelo Araujo

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

Study Record Dates

• First Submitted: October 15, 2010
• First Posted: October 19, 2010
• Study Start: September 13, 2010
• Primary Completion: October 29, 2010
• Study Completion: October 29, 2010
• Last Updated: December 4, 2019
• Results First Posted: December 4, 2019

Record last verified: 2019-11

Locations

US (1)