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
Overview
- Phase
- Phase 4
- Status
- Not yet recruiting
- Sponsor
- Mac Fonseca
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Improvement of Oral Halitosis
Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Coin toss, Lottery, toss of dice, shuffling cards etc
- Masking
- Participant, Investigator and Outcome Assessor Blinded
Eligibility Criteria
- Ages
- 35.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Confirmed diagnosis of type 2 Diabetes mellitus Clinically perceptible halitosis Atleast 20 teeth present Localised or Generalised periodontitis in group.
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Improvement of Oral Halitosis
Time Frame: Baseline, 1 month and 3 months
Secondary Outcomes
- 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)
Investigators
Mac Fonseca
Goa Dental College and Hospital