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Effect of Oral Probiotics Along With Gum Cleaning Treatment in Patients With Advanced Gum Disease in Nepal

Effectiveness of Adjunctive Oral Probiotic in Stage III Periodontitis A Quasi Experimental Study in Nepal - NIL

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/06/112984
Enrollment
96
Registered
2026-06-18
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-22

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

Interventions

Intervention1: Scaling and root planing with adjunctive oral probiotics: Scaling and root planing will be performed under standardized clinical conditions. Participants in the intervention group will

Sponsors

NIL
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients aged 25 to 55 years diagnosed with Stage III periodontitis according to the 2018 AAP/EFP classification, with probing pocket depth of 5 mm or more in at least four sites and clinical attachment loss of 5 mm or more in at least two non-adjacent teeth. Participants must be systemically healthy or medically stable ASA I or II, have a minimum of 20 natural teeth, be willing to comply with study procedures and follow-up visits, and provide written informed consent.

Exclusion criteria

Exclusion criteria: History of periodontal therapy or professional prophylaxis within the last 6 months. Use of systemic antibiotics or anti-inflammatory drugs within the last 3 months. Current or past smokers or tobacco users. Pregnant or lactating women. Known allergy or hypersensitivity to probiotics or any ingredient in the study formulation. Presence of systemic conditions known to affect periodontal disease progression, including uncontrolled diabetes, osteoporosis, immunodeficiency, or immunosuppressive therapy. Patients with aggressive periodontitis, gingival recession more than 3 mm as the primary lesion, or periodontitis associated with other syndromes. Non-compliance or inability to maintain oral hygiene instructions during the study.

Design outcomes

Primary

MeasureTime frame
The primary outcome has been revised to specify the main outcome used for sample size calculation. The revised primary outcome is change in clinical attachment level from baseline to 12 weeks. The time points have been revised as baseline and 12 weeks after intervention.Timepoint: Change in clinical attachment level following scaling and root planing with adjunctive oral probiotic therapy compared with scaling and root planing alone

Secondary

MeasureTime frame
Change in probing pocket depthTimepoint: Baseline, 4 weeks, 8 weeks, and 12 weeks after intervention

Countries

Nepal

Contacts

Public ContactShristi Kafle

Chitwan Medical College

kafle.shristi@gmail.com9849073212

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 29, 2026