N/A
N=100
Efficacy of a Commercial Dentifrice Containing Ilex Rotunda Thunb Extract for Dental Plaque and Gingivitis
Gingivitis · Dental Plaque
Bottom Line
View on ClinicalTrials.gov: NCT02313558 ↗Enrolled (actual)
100
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcome: Primary: Plaque Assessment After 6 Weeks of Dentifrice Use — 2.98; 3.04 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dentifrice Containing Ilex Rotunda Thunb (Drug); Control dentifrice (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Sun Yat-sen University
- Primary completion
- Nov 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Plaque Assessment After 6 Weeks of Dentifrice Use |
2.98; 3.04 | — |
| PRIMARY Gingivitis Assessment After 6 Weeks of Dentifrice Use |
1.22; 1.30 | — |
| PRIMARY Plaque Assessment After 12 Weeks of Dentifrice Use |
2.53; 2.93 | — |
| PRIMARY Gingivitis Assessment After 12 Weeks of Dentifrice Use |
1.13; 1.30 | — |
Summary
The objective of the present study was to compare the anti-plaque and anti-gingivitis effects of a commercially available dentifrice containing 0.6% Ilicis Rotundae Cortex extract to those of a control dentifrice without any active ingredient in 12 weeks of home use.
Eligibility Criteria
Inclusion Criteria
- Patients had to be aged 18 and 70 (inclusive) years in good oral and general health.
- Patients had to possess at least 20 uncrowned permanent natural teeth (excluding third molars).
- Patients should have a whole mouth mean plaque score of at least 1.5(Turesky modification of the Quigley-Hein Plaque Index 12-13) and a whole mouth mean gingivitis score of or greater than 1.0(Löe-Silness Gingival Index14).
Exclusion Criteria
- Patients were excluded from the study if they had moderate to advanced periodontal disease, 5 or more decayed untreated dental sites at screening, other disease of the hard or soft oral tissues. 2. Patients were excluded from the study if they began taking medications that can influence the study outcome, antibiotics or antimicrobial drugs, within one month prior to the start of the study or if they started taking them during the course of the study.
- Pregnant or lactating women, patients who were participating in any other clinical study or who had participated in a study within one month prior to enrollment of study, were not allowed to participate in the study.
- Patients were excluded from the study if they presented orthodontic bands; or partial or removable dentures; or received a dental prophylaxis anytime during the past two weeks prior to the baseline examination; or a history of alcohol or drug abuse; or used the study dentifrice within the last 3 months.
- Patients with a history of allergies to the test products, or allergies to oral care/personal care consumer products or their ingredients, or patients with existing medical conditions, which prohibits them eating and drinking for periods up to four hours, were also excluded from the study.
Data sourced from ClinicalTrials.gov (NCT02313558). 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.