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临床试验/CTRI/2022/06/043334
CTRI/2022/06/043334已完成不适用

Comparative evaluation of Herbal Gel as an adjunct to non-surgical periodontal therapy in stage III periodontitis: Clinico-radiographic study.

Nill1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2022年2月7日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
22
试验地点
1
主要终点
Clinical Attachment Level (CAL)

研究概览

简要总结

This study will be conducted to evaluate and compare the effects of Herbal gel in combination with non- surgical periodontal treatment and non-surgical periodontal treatment alone in a treatment of stage III periodontitis patients, clinically and radiographically by RVG.

A total of 22 subjects including both male and female visiting the Department of Periodontics and implantology at VSPM Dental College and research centre Nagpur will be recruited. Study will be divided into 2 groups

Group I – Stage III periodontitis to be treated with non-surgical periodontal therapy (NSPT).

Group II – Stage III periodontitis to be treated with non-Surgical Periodontal Therapy (NSPT) followed by Herbal gel placement subgingivally.

Prior to initiating the study, its purpose and design will be explained and informed consent will be signed by every patient. Probing pocket depth and clinical attachment level will be measured using UNC #15 probe and custom-made acrylic stent made to compare the measurement at each recall visit. Clinical procedure will consist of Non-Surgical Periodontal Therapy in both groups. Group I patients will be treated by Non-Surgical Periodontal Therapy only. Group II patients will be treated by Non-Surgical Periodontal Therapy and Herbal gel subgingivally, then periodontal pack is given. Patients will be instructed to refrain from chewing hard or sticky foods, brushing near the treated areas, or using any interdental aids for 1 week. Patients will be recalled at 3 months and 6 months postoperatively.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
20.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • Patients with stage III periodontitis as assessed by PPD ≥ 5mm and CAL> 6mm.
  • Patients with at least one pair of IBDs in either maxillary or mandibular arch.

排除标准

  • Patients with history of systemic diseases, allergies or drug usage.
  • Individual had a prior use of non-steroidal anti-inflammatory drugs or antimicrobial drugs in the last 3 months.
  • Pregnant or lactating women.
  • Patient who has undergone periodontal treatment in last 6 months.

结局指标

主要结局

Clinical Attachment Level (CAL)

时间窗: Baseline, 6 Months

Bone Fill

时间窗: Baseline, 6 Months

次要结局

  • PPD (Probing Pocket Depth)(PI (Plaque Index))

研究者

发起方
Nill
申办方类型
Other [none]

研究点 (1)

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