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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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 brus
Sponsor: Sun Yat-sen University

Current Primary Outcome:

  • Plaque Assessment After 6 Weeks of Dentifrice Use [ Time Frame: 6 weeks after dentifrice use ]

    After 6 weeks 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. Third molars and those teeth with cervical restorations or prosthetic crowns were excluded from the scoring procedure. Plaque was disclosed and scored on each tooth surface according to the following criteria: 0 = No plaque; 1 = Separate flecks of plaque at the cervical margin of the tooth; 2 = A thin, continuous band of plaque (up to 1 mm) at the cervical margin of the tooth; 3 = A band of plaque wider than 1 mm, but covering less than 1/3 of the side of the crown of the tooth; 4 = Plaque covering at least 1/3, but less than 2/3 of the side of the crown of the tooth; 5 = Plaque covering 2/3 or more of the side of the crown of the tooth.

    Whole-mouth mean scores were obtained by averaging the values obtained over all scoreable surfaces in the mouth.

  • Gingivitis Assessment After 6 Weeks of Dentifrice Use [ Time Frame: 6 weeks after dentifrice use ]
    After 6 weeks gingivitis was scored according to the Löe-Silness Gingival Index. Each tooth was scored on facial and lingual surfaces. Third molars and those teeth with cervical restorations or prosthetic crowns were excluded from the scoring procedure. The gingiva adjacent to each tooth surface was scored as follows: 0 = Absence of inflammation; 1 = Mild inflammation: slight change in color and little change in texture; 2 = Moderate inflammation: moderate glazing, redness, edema, hypertrophy. Tendency to bleed upon probing; 3

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: Sun Yat-sen University

    Dates:
    Date Received: December 7, 2014
    Date Started: March 2013
    Date Completion:
    Last Updated: May 29, 2015
    Last Verified: May 2015