Efficacy of a Commercial Dentifrice Containing Ilex Rotunda Thunb Extract for Dental Plaque and Gingivitis: A 3-month Clinical Study in Adults in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Gingivitis Assessment After 12 Weeks of Dentifrice Use
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
- •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.
研究组 & 干预措施
Dentifrice Containing Ilex Rotunda Thunb
use the dentifrice containing Ilex Rotunda Thunb to brush teeth twice daily for 12 weeks
干预措施: Dentifrice Containing Ilex Rotunda Thunb (Drug)
control dentifrice
use the control dentifrice to brush teeth twice daily for 12 weeks
干预措施: Control dentifrice (Drug)
结局指标
主要结局
Gingivitis Assessment After 12 Weeks of Dentifrice Use
时间窗: 12 weeks after 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.
Plaque Assessment After 6 Weeks of Dentifrice Use
时间窗: 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.
Plaque Assessment After 12 Weeks of Dentifrice Use
时间窗: 12 weeks after 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 6 Weeks of Dentifrice Use
时间窗: 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 = Severe inflammation: marked redness and hypertrophy. Tendency for spontaneous bleeding.
次要结局
未报告次要终点
研究者
Liu Hongchun
Ph.D.
Sun Yat-sen University