Short-term Effect of 2% Atorvastatin Dentifrice as an Adjunct to Periodontal Therapy: A Randomized Double-blind Clinical Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Change in Periodontal Inflammation Surface Area (PISA)
研究概览
简要总结
Periodontal disease (PD) is an inflammatory, infectious and destructive condition of the tissues surrounding the teeth. However, even if bacteria are required to initiate periodontal disease, the immune response is responsible for most of the destruction of the periodontal tissues. Statins may be used to control the immune response to periodontal pathogens, a factor that has not yet been managed clinically and even less massively.
Recently it has been reported the pharmacological effectiveness of topically used statins. For periodontal disease, at least four well conducted clinical trials have been published using a topically statin formula for pocket irrigation in adult populations with chronic periodontal disease, observing surprising clinical results in all of them (with clinical and statistical significance) and no adverse reactions.
The purpose of the present study is asses the effectiveness of a medicated 2% atorvastatin dentifrice, as complement to non-surgical conventional periodontal treatment. Clinical examination will be made at the beginning and after one month of treatment.
详细描述
An medicated 2% atorvastatin dentifrice (2 mg x every 0.1 ml of dentifrice) will be prepared for dental brushing. It will be used as a base a fluoride dentifrice, to which will be added atorvastatin in the prescribed amount. Medicated prototypes and placebos will be dosed in 5 ml syringes indicating each 0.5 ml measures to facilitate dispensing the product and ensure proper use. Thus, each syringe will be for 10 doses of toothpaste (10 brushings). 6 syringes will be provided to each patient, so that they have enough for a month of treatment, during which they will have to brush 2 times a day.
Sample size:
A clinical trial with two parallel groups (1:1) will be conducted, where there will be 2 groups of 19 patients each. The estimated sample size was based on the difference in attachment level achieved in the study Goodson et al (Goodson, Haffajee, Socransky, Kent, Teles, Hasturk, Bogren, Van Dyke, Wennstrom, Lindhe. Control of periodontal infections: A randomized controlled trial I. The primary outcome attachment gain and pocket depth reduction at Treated sites. J Clin Periodontol 2012, 39: 526-536), with a power of 90%, a significance level of 0.05 two-tailed.
Treatments and protocols:
Patients will be treated at the Department of Periodontology of Health Care Center, Universidad de Los Andes in San Bernardo, Santiago, Chile.
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, Investigator)
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients included in the study will be those fully agreeing to participate by signing an informed consent, which has been submitted to and approved, together with the study protocol by the Ethics Committee of the Faculty of Dentistry of Universidad de Los Andes.
- •The target population consists of 38 adult patients who consult the Service of Periodontology at the Universidad de Los Andes.
- •The eligible population are those that meet the following criteria:
- •more than 35 years of age.
- •with at least 14 natural teeth in mouth (excluding third molars).
- •have some degree of periodontal disease.
排除标准
- •Will be excluded those who:
- •Relate migration plans.
- •Presence of limiting disease for the understanding and execution of the study or are hospitalized.
- •Received periodontal treatment in the last year.
- •Completed antibiotic therapy or Non Steroidal Anti-inflammatory Drugs (NSAIDs) in the last two weeks.
- •Are using calcium channel blockers, phenytoin, cyclosporine or any associated drug that may affect gingival tissue.
- •Have autoimmune pathology.
- •Require antibiotic prophylaxis for periodontal treatment.
- •Patients requiring treatment with NSAIDs for postoperative pain control after the procedure done.
- •Patients on statin therapy for dyslipidemia.
- •Pregnant patients.
研究组 & 干预措施
Medicated 2% atorvastatin dentifrice
A group of 19 patients received non surgical periodontal therapy accompanied by instruction for oral hygiene, using a medicated 2% atorvastatin dentifrice 2 times a day for two minutes each time, for 30 days.
干预措施: Medicated 2% atorvastatin dentifrice (Drug)
Non-medicated dentifrice
A group of 19 patients received non surgical periodontal therapy accompanied by instruction for oral hygiene, using a non-medicated dentifrice as placebo 2 times a day for two minutes each time, for 30 days.
干预措施: Non-medicated dentifrice (Drug)
结局指标
主要结局
Change in Periodontal Inflammation Surface Area (PISA)
时间窗: baseline and 1 month later of intervention
PISA will be computed through an Excel spreadsheet, using data of clinical attachment level, gingival recession and bleeding on probing. Change in PISA: baseline measure minus 1 month later measure.
次要结局
- Change in Clinical Attachment Level (CAL)(baseline and 1 month after intervention)
- Change in Mean Pocket Depth (PD)(baseline and 1 month later)
- Change in Gingival Index(baseline and 1 month after intervention)
- Change in Bleeding on Probing Index (BOP)(baseline and 1 month after intervention)
研究者
Dr. David Rosenberg
Associate Professor of the Faculty of Dentistry
Universidad de los Andes, Chile