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

NCT02313558 | Completed Results DMC

• 1 other identifier: Dentifrice-36
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Gingivitis; Dental Plaque

Keywords

dentifrice; gingivitis; dental plaque

Outcome Measures

Primary Outcomes (4)

• Plaque Assessment After 6 Weeks of 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.

  6 weeks after dentifrice use

• Gingivitis Assessment After 6 Weeks of 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 = Severe inflammation: marked redness and hypertrophy. Tendency for spontaneous bleeding.

  6 weeks after dentifrice use

• Plaque Assessment After 12 Weeks of Dentifrice Use

  After 12 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.

  12 weeks after dentifrice use

• Gingivitis Assessment After 12 Weeks of Dentifrice Use

  After 12 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 = Severe inflammation: marked redness and hypertrophy. Tendency for spontaneous bleeding. Whole-mouth mean scores were obtained by averaging the values obtained over all scoreable surfaces in the mouth.

  12 weeks after dentifrice use

Study Arms (2)

Dentifrice Containing Ilex Rotunda Thunb

EXPERIMENTAL

use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks

Drug: Dentifrice Containing Ilex Rotunda Thunb

control dentifrice

PLACEBO COMPARATOR

use the control dentifrice to brush teeth twice daily for 12 weeks

Drug: Control dentifrice

Interventions

Dentifrice Containing Ilex Rotunda Thunb DRUG

Use the dentifrice to brush teeth twice a day for 12 weeks

Dentifrice Containing Ilex Rotunda Thunb

Control dentifrice DRUG

Use the dentifrice to brush teeth twice a day for 12 weeks

control dentifrice

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• \. 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.
• \. 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.
• \. 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.
• \. 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• West China College of Stomatology: collaborator

Study Sites (1)

West China College of Stomatology

Chengdu, Sichuan, 610041, China

Location

Related Publications (1)

• 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.

  PMID: 22216654 BACKGROUND

MeSH Terms

Conditions

Gingivitis; Dental Plaque

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Dental Deposits; Tooth Diseases

Limitations and Caveats

The major limitation is the lack of a positive control,that is used to determine whether the dentifrice was more or less effective than it. The adoption of an inactive control is possible when the true efficacy of the dentifrice is assessed.

Results Point of Contact

• Title: Dr. Hongchun Liu
• Organization: Guanghua School of Stomatology, Sun Yat-sen University,

hongchun751@sina.com

0086-0-13826189071

Study Officials

• Hongchun Liu, Ph.D.

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D.

Study Record Dates

• First Submitted: December 7, 2014
• First Posted: December 10, 2014
• Study Start: March 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: June 26, 2015
• Results First Posted: January 13, 2015

Record last verified: 2015-05

Locations

CN (1)