Status:
COMPLETED
Study of an Experimental Toothbrush for Treatment and Prevention of Gingivitis
Lead Sponsor:
Johnson & Johnson Consumer and Personal Products Worldwide
Conditions:
Dental Devices, Home Care
Eligibility:
All Genders
18+ years
Phase:
NA
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 week...
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 s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 13 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 29 2010
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT01224158
Start Date
September 13 2010
End Date
October 29 2010
Last Update
December 4 2019
Active Locations (1)
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1
BioSci Research America
Las Vegas, Nevada, United States, 89121