Overview

Efficacy of a Commercial Dentifrice Containing Ilex Rotunda Thunb Extract for Dental Plaque and Gingivitis

Status:
Completed
Trial end date:
2014-11-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Sun Yat-sen University
Collaborator:
West China College of Stomatology
Criteria
Inclusion Criteria:

1. Patients had to be aged 18 and 70 (inclusive) years in good oral and general health.

2. Patients had to possess at least 20 uncrowned permanent natural teeth (excluding third
molars).

3. 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:

1. 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.

3. 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.

4. 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.

5. 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.