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临床试验/NCT06505759
NCT06505759招募中1 期

Evaluation of 2%Bromelain Gel With 0.2%Chlorhexidine Gel as Subgingival Local Drug Delivery Following Scaling and Root Planing in Stage II/III and Grade B Periodontitis -Randomized Control Clinical Trail

Krishnadevaraya College of Dental Sciences & Hospital1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2024年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
招募中
发起方
入组人数
36
试验地点
1
主要终点
Probing pocket Depth (PPD)

研究概览

简要总结

The current study is a prospective randomised study Evaluation of 2%Bromelain Gel With 0.2%Chlorhexidine Gel as Subgingival Local Drug Delivery Following Scaling and Root Planing in Stage II/III and Grade B Periodontitis

详细描述

36 sites with periodontal pocket depth measuring 4-6mm were selected. The sites selected were divided into

  1. Group I (Control)- 12 sites with Probing depth of ≥5mm treated with scaling and root planing alone.
  2. Group II -12 sites with Probing depth of ≥5mm treated with scaling and root planing followed by placement of bromelain gel.
  3. Group III -12 sites with Probing depth of ≥5mm treated with scaling and root planing followed by placement of chlorhexidine gel.

periodontal pack was placed and patient was recalled at 1week,4th week and 12th week

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
None

入排标准

年龄范围
30 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patient with have chronic periodontitis in the age group between 30-50 years.
  • Patients having ≥20 teeth.
  • .Patients with radiographic evidence of bone loss in atleast two teeth.
  • Patients who are systematically healthy.
  • Patients with localized pockets with probing depth of ≤ 5mm.
  • Patients who are cooperative and able to attend the hospital for regular follow-up.

排除标准

  • Patients who have received any surgical or nonsurgical therapy during past 6months
  • Pregnant or lactating females.
  • Use of systemic antibiotics in the past 6 months.
  • Patient who are not willing to give a written informed consent

研究组 & 干预措施

GROUP 1-SRP alone

Active Comparator

control group is treated with SRP alone

干预措施: SRP (Procedure)

GROUP 2-0.2% BROMELAIN gel

Experimental

test group is treated with bromelain gel

干预措施: Bromelain gel (Drug)

GROUP 3-0.2% CHLORHEXIDINE gel

Active Comparator

test group is treated with chlorhexidine gel

干预措施: chlorhexidine gel (Drug)

结局指标

主要结局

Probing pocket Depth (PPD)

时间窗: 3 months

measured using a UNC-15 probe (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA

Relative attachment level (RAL)

时间窗: 3 months

(university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA)

次要结局

  • Gingival index(3 month)
  • Modified Sulcus Bleeding Index(3 months)
  • Plaque Index(3 months)

研究者

发起方
Krishnadevaraya College of Dental Sciences & Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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