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

Primary Purpose

Gingivitis, Dental Plaque

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dentifrice Containing Ilex Rotunda Thunb
Control dentifrice
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gingivitis focused on measuring dentifrice, gingivitis, dental plaque

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • West China College of Stomatology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Dentifrice Containing Ilex Rotunda Thunb

control dentifrice

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 7, 2014
Last Updated
May 29, 2015
Sponsor
Sun Yat-sen University
Collaborators
West China College of Stomatology
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1. Study Identification

Unique Protocol Identification Number
NCT02313558
Brief Title
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

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
Collaborators
West China College of Stomatology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis, Dental Plaque
Keywords
dentifrice, gingivitis, dental plaque

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Dentifrice Containing Ilex Rotunda Thunb
Arm Type
Experimental
Arm Description
use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks
Arm Title
control dentifrice
Arm Type
Placebo Comparator
Arm Description
use the control dentifrice to brush teeth twice daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Dentifrice Containing Ilex Rotunda Thunb
Intervention Description
Use the dentifrice to brush teeth twice a day for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Control dentifrice
Intervention Description
Use the dentifrice to brush teeth twice a day for 12 weeks
Primary Outcome Measure Information:
Title
Plaque Assessment After 6 Weeks of Dentifrice Use
Description
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.
Time Frame
6 weeks after dentifrice use
Title
Gingivitis Assessment After 6 Weeks of Dentifrice Use
Description
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.
Time Frame
6 weeks after dentifrice use
Title
Plaque Assessment After 12 Weeks of Dentifrice Use
Description
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.
Time Frame
12 weeks after dentifrice use
Title
Gingivitis Assessment After 12 Weeks of Dentifrice Use
Description
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.
Time Frame
12 weeks after dentifrice use

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hongchun Liu, Ph.D.
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
West China College of Stomatology
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
22216654
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.
Results Reference
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Efficacy of a Commercial Dentifrice Containing Ilex Rotunda Thunb Extract for Dental Plaque and Gingivitis

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