Clinical trial NCT01224158: Study of an Experimental Toothbrush for Treatment and Prevention of Gingivitis
Official title: Efficacy of an Experimental Toothbrush on the Treatment and Prevention of Gingivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Devices, Home Care
Lead sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
Sponsor class: INDUSTRY
First posted: 2010-10-19
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Detailed description: This is a 42-day, randomized, observer-blind, parallel group, single-center clinical trial. Generally healthy adults will be recruited from a database of known plaque formers. A sufficient number of subjects meeting the necessary inclusion/exclusion criteria will be enrolled into two groups, so that 140 subjects (70 per treatment group) would reasonably be expected to complete the study.

The study will have a pre-experimental phase, which will last 2 weeks followed by an experimental phase that is 4 weeks in duration. At the start of the pre-experimental phase (Day 0), subjects will undergo an initial oral exam, during which gingivitis and pre-brushing plaque evaluations will be performed. Supragingival plaque levels will be assessed on all scorable teeth according to the Rustogi Modified Navy Plaque Index (RMNPI) and gingivitis will be scored according to the Modified Gingival Index (MGI). Subjects with a whole mouth mean plaque level \> 0.60 and a whole mouth mean MGI ≥ 1.75 will then brush their teeth with their assigned toothbrush using American Dental Association (ADA) Accepted fluoride toothpaste. They will be provided with written and verbal instructions to use their toothbrush twice a day, for the next 7 days (Normalization period), allowing the participants to get familiar with the assigned test product. During the second visit (Day 7), the subjects will return the products to the clinical site, and start the experimental gingivitis phase, during which they will only be allowed to use a placebo rinse (W002194-0221P) as means of oral hygiene. The objective of the experimental gingivitis phase is to standardize the levels of plaque and gingivitis in both groups.

At visit 3 (Day 14), subjects will undergo a second gingivitis and pre-brushing plaque evaluation and receive their assigned brush, instructions and diary. They will brush with their assigned toothbrush for two weeks (14 days), using an ADA accepted fluoride toothpaste. During the fourth visit (Day 28), the subjects will return to the site and undergo a third gingivitis and post-brushing plaque evaluation. At the last visit (Day 42), the study participants will undergo final gingivitis and post-brushing plaque evaluations and return all used products.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Whole-mouth Mean Modified Gingival Index (MGI) Score at Day 42
timeFrame: Day 42
Secondary outcomes:
measure: Whole-mouth Mean Modified Gingival Index (MGI) Score at Day 28
timeFrame: Day 28
measure: Whole-mouth Mean Rustogi Modified Navy Plaque Index (RMNPI) Score at Day 42
timeFrame: Day 42
measure: Whole-Mouth Mean Rustogi Modified Navy Plaque Index (RMNPI) Score at Day 28
timeFrame: Day 28
measure: Hard-to-reach Mean Rustogi Modified Navy Plaque Index (RMNPI) at Day 28 and 42
timeFrame: Day 28 and 42
measure: Mean Rustogi Modified Navy Plaque Index (RMNPI) at Day 28 and 42 for Each Hard-to-reach Area
timeFrame: Day 28 and 42
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: BioSci Research America
state: Nevada
Study officials:
affiliation: Johnson & Johnson Consumer and Personal Products Worldwide
name: Marcelo Araujo
role: STUDY_DIRECTOR
References: