Clinical trial NCT02313558: Efficacy of a Commercial Dentifrice Containing Ilex Rotunda Thunb Extract for Dental Plaque and Gingivitis
Official title: Efficacy of a Commercial Dentifrice Containing Ilex Rotunda Thunb Extract for Dental Plaque and Gingivitis: A 3-month Clinical Study in Adults in China
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gingivitis
Dental Plaque
Keywords: dentifrice
gingivitis
dental plaque
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: West China College of Stomatology
First posted: 2014-12-10
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 control dentifrice without any active ingredient in 12 weeks of home use.

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-consent forms were reviewed and approved by the institutional review board at the West China College of Stomatology at Sichuan University.

Prospective patients aged 18 to 70 years in good oral and general health were examined during the screening visit.Patients were included according to inclusion and exclusion criteria.

The study participants refrained from all oral hygiene procedures for at least 12 hours as well as from eating, drinking and smoking for 4 hours prior to the baseline examinations. Eligible patients were randomly assigned to receive a commercially available dentifrice containing 0.6% Ilicis Rotundae Cortex extract (experimental group) or a dentifrice without any active ingredient (control group). Random assignment to groups was performed externally by another dentist, using a computer-generated randomization sequence; all other study personnel were neither involved in the randomization process nor aware of treatment assignments in any outcome evaluation.

All dentifrices were supplied in their original packaging (the experimental and control dentifrices were identical in appearance \[including size, color, and shape\] and taste). The dentifrices were covered to mask their identity and provided with a unique code that was not decoded until the conclusion of the study. The test product was distributed in a separate area, and all other study personnel and study participants were blinded to treatment assignment.

Patients were provided with their assigned product and the same soft-bristled toothbrush for unsupervised brushing for 12 weeks. Patients were instructed to brush their teeth twice a day (in the morning and in the evening) for 1 minute, using enough toothpaste to cover the entire brush, and to refrain from any other oral hygiene procedures throughout the duration of the study. There were no restrictions regarding diet or smoking habits during the course of the study. Patients were requested to return to the clinic after 6 weeks and 12 weeks for follow-ups, having refrained from all oral hygiene procedures for at least 12 hours before, and from eating, drinking and smoking for 4 hours before, the scheduled visit.

Patients were evaluated at baseline, after 6 weeks, and after 12 weeks of use. At each point, patients received oral examinations of their hard and soft tissues, followed by an evaluation of gingivitis and dental plaque. Patients were asked whether they had the presence of adverse events such as any discomfort while brushing and alterations in taste. All examinations were performed by the same investigator throughout the study. However, after each examination, the gingivitis and plaque scores were kept by the facilitator, and the investigator did not have access to the scores of the patients.

Dental plaque examination: Supra-gingival plaque on the facial and lingual surfaces of each tooth was scored according to the Turesky modification of the Quigley-Hein Plaque Index.

Gingivitis examination: Gingivitis was scored according to the Löe-Silness Gingival Index.

Adverse Events: Clinical evaluations by an investigator at each scheduled visit included assessments of both oral hard and soft tissue. Patients were interviewed during these examinations for any adverse events or changes in their health status. All patients underwent their final clinical examination at the conclusion of the study.

Eligibility 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.

Primary outcomes:
measure: Plaque Assessment After 6 Weeks of Dentifrice Use
timeFrame: 6 weeks after dentifrice use
measure: Gingivitis Assessment After 6 Weeks of Dentifrice Use
timeFrame: 6 weeks after dentifrice use
measure: Plaque Assessment After 12 Weeks of Dentifrice Use
timeFrame: 12 weeks after dentifrice use
measure: Gingivitis Assessment After 12 Weeks of Dentifrice Use
timeFrame: 12 weeks after dentifrice use
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China College of Stomatology
state: Sichuan
Study officials:
affiliation: Sun Yat-sen University
name: Hongchun Liu, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mankodi S, Chaknis P, Panagakos FS, DeVizio W, Proskin HM. Comparative investigation of a dentifrice containing triclosan/copolymer/sodium fluoride and specially-designed silica and a dentifrice containing 0.243% sodium fluoride in a silica base for the control of established supra-gingival plaque and gingivitis: a 6-month clinical study. Am J Dent. 2011 Jul;24 Spec No A:21A-27A.