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
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
Mac Fonseca
Goa Dental College and Hospital
