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A clinical and microbiological randomized trial to compare the effect of oral probiotics on bad breath in diabetic patients, with and without periodontitis

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 - NIL

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/08/093008
Enrollment
60
Registered
2025-08-13
Start date
Unknown
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K053- Chronic periodontitis Health Condition 2: R196- Halitosis Health Condition 3: E119- Type 2 diabetes mellitus without complications

Interventions

Intervention1: Diabetic Patients(HbA1c 8%) who have Oral Halitosis with Periodontitis and treated with Oral Prophylaxis and a chewable Oral Probiotic: Blood investigations to evaluate the glycated hae

Sponsors

Mac Fonseca
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Improvement of Oral HalitosisTimepoint: Baseline, 1 month and 3 months

Secondary

MeasureTime frame
Change in Microbiological assay(P gingivalis) Timepoint: Baseline and 3 months;Reduction in HbA1cTimepoint: Baseline and 3 months;Reduction in Plaque indexTimepoint: Baseline and 3 months;Reduction in gingival indexTimepoint: Baseline and 3 months

Countries

India

Contacts

Public ContactDr James Samuel

Goa Dental College and Hospital

scorpian5mac@gmail.com8975249860

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026