跳至主要内容
临床试验/CTRI/2025/08/093008
CTRI/2025/08/093008尚未招募4 期

A comparative study to evaluate and assess the efficacy of oral probiotics on oral halitosis in uncontrolled diabetics with and without periodontitis: a clinico- microbiological randomized controlled trial

Mac Fonseca1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年9月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Improvement of Oral Halitosis

研究概览

简要总结

The study is a randomised controlled trial to evaluate the clinical effect of Oral Probiotics as an adjunct to scaling and root planing(SRP) in the treatment of Oral Halitosis in Diabetic patients with and without Periodontitis The Objectives of the study are1)To evaluate the clinical effect of Oral Probiotic as an adjunct therapy to SRP on Oral Halitosis in a)Diabetic patients without Periodontitis b)Diabetic patients with Periodontitis 2)To evaluate the clinical effect of SRP on microbiological parameters of P. gingivalis in plaque samples at baseline and in six weeks                            3)To evaluate the clinical effect of only SRP on Oral Halitosis in

a)Diabetic patients without Periodontitis       b)Diabetic patients with Periodontitis IV. To evaluate the effect of the intervention on the Glycated haemoglobin after 3 months V.To compare the clinical parameters on test and control groups

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, Investigator and Outcome Assessor Blinded

入排标准

年龄范围
35.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Confirmed diagnosis of type 2 Diabetes mellitus Clinically perceptible halitosis Atleast 20 teeth present Localised or Generalised periodontitis in group.

排除标准

  • Patients taking any other medications Patients with known allergies or hypersensitivity reactions Pregnant and lactating women Subjects who underwent periodontal treatment within a period of 6 months H/O antibiotic intake at least 3 months prior H/O use of mouthwashes within 4 weeks before the start of the study.

结局指标

主要结局

Improvement of Oral Halitosis

时间窗: Baseline, 1 month and 3 months

次要结局

  • Change in Microbiological assay(P gingivalis)
  • Reduction in HbA1c(Baseline and 3 months)
  • Reduction in Plaque index(Baseline and 3 months)
  • Reduction in gingival index(Baseline and 3 months)

研究者

发起方
Mac Fonseca
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Mac Fonseca

Goa Dental College and Hospital

研究点 (1)

Loading locations...

相似试验