Efficacy of Locally Delivered Rosemary Extract Gel as an Adjunct to Non-Surgical Periodontal Therapy in Management of Periodontitis (A Randomized Controlled Clinical Trial With Microbiological Analysis)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- probing depth
研究概览
简要总结
Rosemary extract is known for its antibacterial, anti-inflammatory and anti-oxidant properties that make it a promising therapeutic aid as a local delivery drug in deep periodontal pockets in adjunct to non-surgical periodontal therapy in management of periodontitis. These properties are due to the high content of phenolic compounds such as carnosic acid, urolic acid, rosmarinic acid or chlorogenic acid. Rosemary extract was previously investigated and proved its effectiveness against periodontopathogens in-vitro. Thus, its selected for this study to be administered in a gel form to assess its efficacy in management of periodontitis.
详细描述
Forty eight patients with deep periodontal pockets more than 5 mm will be randomly assigned into 2 equal groups. The test group will receive the rosemary extract gel in adjunct to non-surgical periodontal therapy, while the control group will receive placebo gel.
Clinical evaluation of the clinical parameters including probing depth, gingival index, plaque index and clinical attachment level will be recorded.
Microbiological analysis using PCR test will be performed using perio-papers.
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
- 25 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Both genders aged between 25-45 years.
- •Healthy adult patients as evidenced by Burket's oral medicine health history questionnaire.
- •Stage III grade B periodontitis with at least two non-adjacent sites in posterior teeth with PD ≥ 6 mm, CAL ≥ 5 mm showing BOP and ≤ 4 teeth lost due to periodontitis.
- •Patients ready to comply with oral hygiene measures.
排除标准
- •Pregnant or lactating females.
- •Drug abusers.
- •Patients taking antibiotics or performed any periodontal treatment in the previous 6 months.
- •Patients who have a known allergy or hypersensitivity to rosemary, its constituents, or other members of the Lamiaceae family.
- •Patients with parafunctional habits.
研究组 & 干预措施
Rosemary extract gel
rosemary extract gel will be applied in deep periodontal pockets with a concentration 5%.
干预措施: Herbal therapy (Drug)
placebo gel
a placebo gel will be applied in deep periodontal pockets in stage III periodontitis patients as an adjunct to non-surgical periodontal therapy.
干预措施: Placebo Drug (Drug)
结局指标
主要结局
probing depth
时间窗: change from baseline at 3 months
Will be measured from the gingival margin to the bottom of the periodontal pocket to the nearest mm. with use of UNC 15 periodontal probe.
次要结局
- microbiological analysis(The bacterial load in the GCF sample will be assessed at baseline, 1 week and 1 month post-operatively.)
- clinical attachment level, plaque index and gingival index(change from baseline at 3 months)
研究者
Roba abdelhamid mohamed elhady
Resident dentist at department of oral medicine and periodontology
Ain Shams University