Status:
COMPLETED
Efficacy of a Commercial Dentifrice Containing Ilex Rotunda Thunb Extract for Dental Plaque and Gingivitis
Lead Sponsor:
Sun Yat-sen University
Collaborating Sponsors:
West China College of Stomatology
Conditions:
Gingivitis
Dental Plaque
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief 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 contro...
Detailed Description
This 12-week, randomized, double-blind, parallel-group study was conducted at the State Key Laboratory of Oral Diseases, Sichuan University, Chengdu, China. The clinical study protocol and informed-co...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2014
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02313558
Start Date
March 1 2013
End Date
November 1 2014
Last Update
June 26 2015
Active Locations (1)
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1
West China College of Stomatology
Chengdu, Sichuan, China, 610041