N/A
N=153
Study of an Experimental Toothbrush for Treatment and Prevention of Gingivitis
Dental Devices, Home Care
Bottom Line
View on ClinicalTrials.gov: NCT01224158 ↗Enrolled (actual)
153
Serious AEs
0.0%
Results posted
Dec 2019
Primary outcome: Primary: Whole-mouth Mean Modified Gingival Index (MGI) Score at Day 42 — 1.880; 1.770 Unit on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Experimental Power Toothbrush (Device); Flat trimmed Manual Toothbrush (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Whole-mouth Mean Modified Gingival Index (MGI) Score at Day 42 |
1.880; 1.770 | — |
| SECONDARY Whole-mouth Mean Modified Gingival Index (MGI) Score at Day 28 |
1.957; 1.868 | — |
| SECONDARY Whole-mouth Mean Rustogi Modified Navy Plaque Index (RMNPI) Score at Day 42 |
0.146; 0.131 | — |
| SECONDARY Whole-Mouth Mean Rustogi Modified Navy Plaque Index (RMNPI) Score at Day 28 |
0.164; 0.148 | — |
| SECONDARY Hard-to-reach Mean Rustogi Modified Navy Plaque Index (RMNPI) at Day 28 and 42 |
0.232; 0.209; 0.208; 0.186 | — |
| SECONDARY Mean Rustogi Modified Navy Plaque Index (RMNPI) at Day 28 and 42 for Each Hard-to-reach Area |
0.298; 0.271; 0.273; 0.246; 0.413; 0.399 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01224158). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.