N/A
N=158
A Clinical Trial to Test the Effect of Marketed Mouth Rinses on Decreasing Plaque and Gum Inflammation
Plaque · Gingivitis
Bottom Line
View on ClinicalTrials.gov: NCT02233998 ↗Enrolled (actual)
158
Serious AEs
0.0%
Results posted
Jul 2015
Primary outcome: Primary: Whole Mouth Mean Modified Gingival Index (MGI) at Week 3 — 2.004; 1.770; 1.807 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mouth Rinse 1 (Other); Mouth Rinse 2 (Other); Mouth Rinse 3 (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Consumer and Personal Products Worldwide
- Primary completion
- Sep 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Whole Mouth Mean Modified Gingival Index (MGI) at Week 3 |
2.004; 1.770; 1.807 | <0.001 sig |
| PRIMARY Whole Mouth Mean Plaque Index (PI) at Week 3 |
2.434; 1.965; 2.055 | <0.001 sig |
| SECONDARY Whole Mouth Mean Gingival Bleeding Index (BI) at Week 3 |
0.098; 0.067; 0.072 | <0.001 sig |
| SECONDARY Change From Baseline in the Percentage of Healthy Sites (Modified Gingival Index (MGI) Scores of 0 or 1) at Week 3 |
5.5; 27.5; 24.3 | <0.001 sig |
| SECONDARY Change From Baseline in the Percentage of Virtually Plaque-Free Sites (Plaque Index (PI) Scores of 0 or 1) at Week 3 |
3.2; 20.9; 18.3 | <0.001 sig |
| SECONDARY Change From Baseline in the Percentage of Non-Bleeding Sites (Gingival Bleeding Index (BI) Scores of 0) at Week 3 |
0.3; 2.5; 2.1 | <0.001 sig |
| SECONDARY Change From Baseline in the Percentage of Problem Sites (Modified Gingival Index (MGI) Scores of ≥ 3) at Week 3 |
-0.6; 0.9; 0.3 | 0.016 sig |
| SECONDARY Change From Baseline in the Percentage of Problem Sites (Plaque Index (PI) Scores of ≥ 3) at Week 3 |
0.1; 23.5; 18.9 | <0.001 sig |
| SECONDARY Change From Baseline in the Percentage of Problem Sites (Plaque Index (PI) Scores of ≥ 2) at Week 3 |
3.2; 20.9; 18.3 | <0.001 sig |
Summary
The reduction of existing plaque and gum inflammation will be evaluated using two marketed mouth rinses along with tooth brushing after 21 days of use compared to a placebo mouth rinse.
165 healthy volunteers will be enrolled in this three week study. Volunteers who qualify to be in this study will have an equal chance of being assigned to one of the three treatment groups. Volunteers will have a total of three visits including 1) Screening/Baseline Day 1 2) Day 11 (after 10 days of use) and 3) Day 22 (after 21 days of use). Volunteers will maintain a diary at home to record each treatment use and will be asked to come to the clinic without brushing or use their product for at least 8 hours, but no more than 18 hours. Examinations for oral hard/soft tissue, gingivitis, bleeding and plaque assessments will be completed at Screening/Baseline and repeated at Clinic Visit 3, which is Day 22.
Eligibility Criteria
Inclusion Criteria
- Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel's assessment;
- 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;
- Males and females 18 years of age or older, in good general and oral health without any known allergy to commercial dental products;
- A minimum of 20 natural teeth with scorable facial and lingual surfaces. Teeth that are grossly carious, extensively restored, orthodontically banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion, or third molars will not be included in the tooth count;
- A mean gingival index ≥ 1.95 according to the Modified Gingival Index;
- A mean plaque index ≥ 1.95 according to the Turesky modification of the Quigley-Hein Plaque Index scored on six surfaces per tooth;
- Absence of significant oral soft tissue pathology, excluding plaque-induced gingivitis, based on a visual examination and at the discretion of the Investigator;
- Absence of moderate/advanced periodontitis based on a clinical examination (ADA Type III, IV).
- Absence of fixed or removable orthodontic appliance or removable partial dentures;
- Able to read and understand the local language;
- Male or non-pregnant, non-lactating female, by self-report;
- Male and female subjects with reproductive potential must agree to practice a medically acceptable form of birth control during the study and for 30 days following the last dose of investigational product. Females must have used such birth control for at least 3 months prior to the Baseline visit.
Medically acceptable forms of birth control that may be used by the subject and/or his/her partner include:
- Abstinence from reproductive intercourse when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptom-thermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception;
- Established use of hormonal methods of contraception (oral, injected, implanted, patch or vaginal ring);
- Intrauterine device (IUD) or intrauterine system (IUS);
- Barrier methods of contraception with spermicide: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository;
- Surgical sterilization (e.g., vasectomy that has been confirmed effective by sperm count check, tubal occlusion, hysterectomy, bilateral salpingectomy); and
- A female subject who is postmenopausal (i.e., amenorrheic for at least 12 months prior to the Baseline visit) is not considered of reproductive potential.
- Willing for this to be the only investigational product used during this time period; and
- Willing and able to comply with all study procedures and attend the scheduled visits for the duration of the study.
Exclusion Criteria
Subjects presenting with any of the following will not be included in the study:
- History of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes and mouth rinses and red food dye;
- Dental prophylaxis within 2 weeks prior to Screening visit;
- Antibiotic, anti-inflammatory or anticoagulant therapy during the study or within one month prior to the baseline exam;
- Regular use of chemotherapeutic antiplaque/antigingivitis products such as triclosan, essential oil, cetylpyridinium chloride, or chlorhexidine containing mouth rinses within three weeks prior to baseline;
- Self-reported pregnancy or lactation (this criterion is due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study results);
- Significant unstable or uncontrolled medical condition which may interfere with a subject's participation in the study, at the discretion of
Data sourced from ClinicalTrials.gov (NCT02233998). 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.