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Probiotic Therapy in Diabetes Patients With Periodontitis

Probiotic Therapy as an Adjunct Treatment in Periodontitis Patients with Type 2 Diabetes Mellitus: A Randomized Controlled Clinical Trial - NIL

Status
Active, not recruiting
Phases
Phase 3Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/083180
Enrollment
40
Registered
2025-03-24
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Health Condition 1: K056- Periodontal disease, unspecified

Interventions

Intervention1: Probiotic Tablet (Orabiome) - Each tablet contains 1 billion cfu of levilactobacillus brevis CD2: 1 tablet BD for 14 days Control Intervention1: Placebo (contains all ingredients except

Sponsors

Department of Periodontology Ahmedabad Dental College and Hospital
Lead Sponsor
Next Gen Pharma India Pvt Ltd
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 1) Patients with Type 2 Diabetes Mellitus and HbA1c more than 7. 3) Moderate to severe periodontal disease. 4) Probing depth more than 4mm. 5) Patients who can provide informed consent.

Exclusion criteria

Exclusion criteria: 1) Pregnancy or lactating women. 2) Patients who have taken antibiotics within last 3 months. 3) Patients with known allergy to probiotics or to tablet contents. 4) Patients who have received periodontal therapy in past 6 months.

Design outcomes

Primary

MeasureTime frame
Clinical parameters (Gingival Index, Plaque Index, Probing Pocket Depth, Clinical Attachment Level)Timepoint: Baseline, 1 month and 3 months

Secondary

MeasureTime frame
1) Clinical Parameters - HbA1c and PPBS 2) Microbiological assessment of gram negative pathogensTimepoint: Baseline, 1 month and 3 months

Countries

India

Contacts

Public ContactDivya ManojBhai Rathi

Ahmedabad Dental College and Hospital

drmishalshah@yahoo.com9913602125, 9909218929

Outcome results

None listed

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