跳至主要内容
临床试验/CTRI/2024/08/073139
CTRI/2024/08/073139尚未招募Phase 3 4

Evaluation of Effectiveness of Mangosteen gel as an Adjunct to One-Stage Full-Mouth Disinfection in Periodontitis: A Clinical Study

Sharad Pawar Dental College SawangiMeghe1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年9月16日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
30
试验地点
1
主要终点
Use of Mangosteen adjunct to Full Mouth Disinfection may lead to better outcomes

研究概览

简要总结

Full-mouth disinfection is a treatment method for periodontitis. The aim of this treatment is to manage periodontal pockets by preventing infection of periodontal pathogens and intraoral bacterial reservoirs, such as tonsils, tongue, and other mucous membranes, that could lead to a disease recurrence. In this method, the entire mouth is disinfected in a single session, which includes scaling and root planing (SRP) and the use of antimicrobial agents such as chlorhexidine (CHX). In this study, 30 patients will be equally distributed in two different groups. Group A (n=15) will be alloted with conventional Full-mouth disinfection(FMD) and Group B(n=15) will undergo application of Mangosteen gel in periodontal pockets adjunt to conventional FMD. Expected outcomes will be the group with adjunct use of Mangosteen gel will give better results.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

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

入选标准

  • Generalized interproximal attachment loss involving at least three teeth apart from molars and first incisors.
  • Amount of microbial deposits inconsistent with the severity of periodontal tissue destruction.
  • Patients with a minimum number of 20 teeth.
  • Patients with clinical attachment loss and probing depths (PDs) ≥ 4 mm at 2 sites of a minimum of 12 teeth.
  • The patients included in the study should be systemically healthy.
  • Patients with no history of periodontal therapy in the preceding 6 months or under any antibiotic therapy.
  • Patients motivated to have the therapy and willing to complete the follow-up.

排除标准

  • Patients with a known or suspected allergy
  • Patients who have undergone periodontal therapy in the last 6 months.
  • Patients with any systemic disorder affecting periodontal health.
  • Patients with infectious conditions other than periodontitis.
  • Chronic alcoholics
  • Patients consuming tobacco in any form and smokers.
  • Immuno-compromised and systemically-unhealthy patients.
  • Pregnant or lactating females.

结局指标

主要结局

Use of Mangosteen adjunct to Full Mouth Disinfection may lead to better outcomes

时间窗: Assesment will be done at baseline, 3 months, 6 months

次要结局

  • N/A(N/A)

研究者

发起方
Sharad Pawar Dental College SawangiMeghe
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Shivani Thakre

Sharad Pawar Dental College

研究点 (1)

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