NCT07532694

Diode Laser-Assisted Periodontal Therapy in Kidney Transplant Recipients

Periodontal Status in Kidney Transplant Patients and the Effectiveness of Adjunctive Diode Laser Therapy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Military Hospital 103 · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

Summary

This randomized controlled trial evaluates the efficacy of diode laser-assisted non-surgical periodontal therapy in kidney transplant recipients with periodontitis. Eighty participants will be allocated to two parallel groups: scaling and root planing (SRP) with adjunctive diode laser therapy or SRP alone. Clinical periodontal parameters, blood biomarkers, radiographic findings, and subgingival microbiome profiles will be assessed at baseline and during follow-up. The study aims to determine whether adjunctive diode laser therapy provides superior clinical and biological improvement compared with SRP alone.

Detailed description

* This is a prospective, parallel-group, randomized controlled clinical trial in kidney transplant recipients diagnosed with periodontitis. * Participants will be randomized in a 1:1 ratio to receive either SRP with adjunctive diode laser therapy (intervention arm) or SRP alone (control arm). * Follow-up visits are scheduled at baseline, 1 month, 3 months, and 6 months after treatment. * Main clinical outcomes include clinical attachment level (CAL), probing pocket depth (PPD), plaque-related indices, gingival inflammation (GI), bleeding on probing (BOP), and oral hygiene status (OHI-S). * Systemic laboratory outcomes include platelet count, urea, creatinine, and C-reactive protein (CRP). * Subgingival plaque samples will undergo next-generation sequencing of 16S ribosomal RNA (16S rRNA) at baseline and 1 month after treatment to evaluate microbiome changes. * Alveolar bone changes will be assessed radiographically according to the study imaging protocol.

Conditions

• Periodontitis
• Kidney Transplant Recipients

Interventions

Type	Name	Description
PROCEDURE	Scaling and Root Planing	Conventional non-surgical periodontal therapy performed according to the study protocol in both groups.
DEVICE	Diode Laser	Adjunctive diode laser application to periodontal pockets after SRP in the experimental arm. Device specifications, wavelength, power settings, mode, fiber size, number of applications, and treatment sessions should match the approved protocol exactly.

Timeline

• Start date: 2025-12-09
• Primary completion: 2026-06-09
• Completion: 2026-06-09
• First posted: 2026-04-16
• Last updated: 2026-04-16

Locations

2 sites across 1 country: Vietnam