Efficacy of a Commercial Dentifrice Containing Ilex Rotunda Thunb Extract for Dental Plaque and Gingivitis
Condition: Gingivitis; Dental Plaque
MeSH terms: Gingivitis; Dental Plaque
Study type: Interventional

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.
    

Intervention name(s): Dentifrice Containing Ilex Rotunda Thunb; Control dentifrice
Intervention type(s): Drug; Drug
Intervention description(s): Use the dentifrice to brush teeth twice a day for 12 weeks; Use the dentifrice to brush teeth twice a day for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: dentifrice; gingivitis; dental plaque