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临床试验/CTRI/2025/06/088488
CTRI/2025/06/088488尚未招募2 期

The efficacy of adjunct use of supragingival air polishing therapy with erythritol powder compared to conventional SRP alone during phase 1 periodontal therapy

Sri Ramachandra Institute of Higher Education and Research1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2025年6月24日最近更新:
适应症

试验速览

阶段
2 期
状态
尚未招募
入组人数
24
试验地点
1
主要终点
To assess the reduction in bleeding on probing, Clinical attachment loss and Pocket probing Depth.

研究概览

简要总结

A total of 12 patients with Grade 2 periodontitis  were choosen for this split mouth study, randomly quadrants were selected for test and control groups in this single centred, clinical trial. Each group including 12 quadrants were randomly selected for test and control group. Test group will be  treated with scaling and root planning with erythritol powder supragingival air polishing as adjunct.Control group will be treated with Scaling and root planning alone. Every patient who satisfies the requirements for inclusion will be progressively included to the experiment . Using an envelope system and a computer generated table, Each patient will be randomly assigned to receive either the test group (scaling and root planning with erythritol powder supragingival air polishing as adjunct) and Control group(Scaling and root planning alone). Patients in the test group will be treated with conventional SRP with supragingival erythritol air polishing device using Prophyjet air polishing device for 5 seconds  each tooth. To assess the changes in the clinical periodontal parameters( Bleeding on probing, plaque index, Probing depth, clinical attachment loss and PISA) and microbial analysis using plaque samples at baseline and 3 weeks follow up period. The non- surgical periodontal therapy for the assigned patients will be performed in the department of periodontology, prior to therapy, all study participants underwent a comprehensive diagnostic evaluation that comprised a radiograph of the afflicted area, intraoral photos, and routine blood parameter checks, bleeding time, clotting time .A comprehensive oral prophylaxis were then carried out . The modified plaque index( Silness and Loe, 1964) , the modified sulcus bleeding index ( Mombelli et al., 1987 ) will be done to quantify oral hygiene at baseline for all the patients prior to oral prophylaxis. Using the UNC-15 probe, the probing pocket depth and clinical attachment loss will be assessed. Clinical parameters( Bleeding on probing, plaque index, Probing depth, clinical attachment loss and PISA) and microbial analysis will be assessed at baseline and 4 weeks following the initial instrumentation.

研究设计

研究类型
Interventional
分配方式
Computer generated randomization
盲法
Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • •1.Patients with periodontitis had completed comprehensive periodontal therapy at least three months and were in their maintenance period.
  • •2.Periodontal PD not more than 5 mm.
  • •3.Remaining more than 20 teeth.
  • •4.Without systemic disease.
  • •No smoking.

排除标准

  • •1.Subjects who use tobacco in any form.
  • •2.Subjects who have periodontal disease and are undergoing orthodontic treatment previously underwent maxillofacial surgery.
  • •3.Subjects who have taken antibiotics in the past 6 months.
  • •Subjects who Have taken analgesics in past 1week.
  • •Pregnant and lactating women.
  • •6.Subjects with a previous history of surgical periodontal therapy 7.Patients unable to maintain sufficient oral hygiene were also excluded from the study.

结局指标

主要结局

To assess the reduction in bleeding on probing, Clinical attachment loss and Pocket probing Depth.

时间窗: Baseline and 3 weeks

次要结局

  • Reduction in microbial(Porphyromonas gingivalis) load(Baseline and 3 weeks)

研究者

申办方类型
Other [Dental College and research institute]

研究点 (1)

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