Efficiency of Flurbiprofen 2.5% in Comparison to 98% Aloe Vera Gel as an Adjunctive Therapy to Scaling and Root Planning in the Initial Treatment of Stage III Chronic Periodontitis in Smoking Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- clinical attachment level
研究概览
简要总结
This study aims to evaluate clinically the efficacy of flurbiprofen gel in comparison to Aloe Vera gel as adjunctive to SRP in the reduction of periodontal pockets in patients with chronic periodontitis in smoking patients.
All patients will receive SRP prior to treatment.
- Group 1: one site will receive flurbiprofen while the contralateral site will receive a placebo
- Group 2: one site will receive aloe vera while the contralateral site will receive a placebo
- Group 3: one site will receive flurbiprofen while the contralateral site will receive aloe vera Researchers will compare the inter and intra-groups differences to check if there's a variation in the periodontal parameters measured.
详细描述
Complete medical and dental histories as well as informed consent will be collected from eligible participants, and periodontal charting will be done for them.
Medical history and laboratory screening for all patients will be carried out at baseline. All participants will undergo scaling and root planning. The selected patients will be allocated into three groups with the help of a computerized randomizer (Randomizer.org) and sites will be assigned as control or test based on a coin flip method:
- Group 1 (G1): 20 patients who received treatment involving the application of flurbiprofen gel as an adjunct to scaling and root planing. Specifically, on the test site of each patient, one milliliter of 2.5% flurbiprofen gel was applied, while on the contralateral side, placebo gel was administered as the control intervention.
- Group 2 (G2): 20 patients who received treatment involving the application of aloe Vera gel as an adjunct to scaling and root planing. Specifically, on the test site of each patient, one milliliter of 98% aloe Vera was applied, while on the contralateral side, placebo gel was administered as the control intervention.
- Group 3 (G3): The intervention involved applying flurbiprofen gel on one site, while the contralateral side received an application of 98% aloe vera.
The clinical examiner will not be informed of the treatment groups' distribution.
Patients will be informed on self-performed plaque control measures. In the 4th week, 8th week, 12th week, 6 months week clinical examination will be performed to measure the periodontal pocket depth, gingival index, plaque index, clinical attachment level (CAL),and bleeding on probing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
scaling and root planing + 2.5% flurbiprofen on one site and placebo on contralateral site
Following scaling and root planing, the prepared 2.5% flurbiprofen was injected subgingivally in the selected deep pocket and the same was done with a placebo on the contralateral site
干预措施: 2.5% flurbiprofen (Drug)
scaling and root planing + 2.5% flurbiprofen on one site and placebo on contralateral site
Following scaling and root planing, the prepared 2.5% flurbiprofen was injected subgingivally in the selected deep pocket and the same was done with a placebo on the contralateral site
干预措施: Placebo (Other)
scaling and root planing + 98% aloe vera on one site and placebo on contralateral site
Following scaling and root planing, the prepared aloe vera was injected subgingivally in the selected deep pocket and the same was done with a placebo on the contralateral site
干预措施: 98% aloe vera (Drug)
scaling and root planing + 98% aloe vera on one site and placebo on contralateral site
Following scaling and root planing, the prepared aloe vera was injected subgingivally in the selected deep pocket and the same was done with a placebo on the contralateral site
干预措施: Placebo (Other)
scaling and root planing + 2.5% flurbiprofen on one site and 98% aloe vera on contralateral site
Following scaling and root planing, the prepared 2.5% flurbiprofen was injected subgingivally in the selected deep pocket while the same was done with 98% aloe vera on the contralateral site
干预措施: 2.5% flurbiprofen (Drug)
scaling and root planing + 2.5% flurbiprofen on one site and 98% aloe vera on contralateral site
Following scaling and root planing, the prepared 2.5% flurbiprofen was injected subgingivally in the selected deep pocket while the same was done with 98% aloe vera on the contralateral site
干预措施: 98% aloe vera (Drug)
结局指标
主要结局
clinical attachment level
时间窗: 6 months
used to assess the loss of periodontal tissue support in periodontitis. It is the distance from the cemento-enamel junction (fixed point on the tooth) to the depth of the pocket
Probing Depth
时间窗: 6 months
used to detect the depth of the periodontal pocket. It is the distance from the gingival margin to the base of the pocket.
次要结局
- Gingival index(6 months)
- Bleeding on Probing(6 months)
- Plaque index(6 months)