Diode Laser-Assisted Periodontal Therapy in Kidney Transplant Recipients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Scaling and Root Planing, Diode Laser.
- Who it may be relevant to
- Registry conditions: Periodontitis, Kidney Transplant Recipients. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Vietnam
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Periodontal Status in Kidney Transplant Patients and the Effectiveness of Adjunctive Diode Laser Therapy
Overview
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.
Interventions
- 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.
Primary outcome measures
- Change in clinical attachment level (CAL) [Time frame: Baseline, 1 month, 3 months, and 6 months]
- Change in probing pocket depth (PPD) [Time frame: Baseline, 1 month, 3 months, and 6 months]
Secondary outcome measures (8)
- Change in bleeding on probing (BOP) [Time frame: Baseline, 1 month, 3 months, and 6 months]
- Change in gingival index (GI) [Time frame: Baseline, 1 month, 3 months, and 6 months]
- Change in plaque index (PlI) [Time frame: Baseline, 1 month, 3 months, and 6 months]
- Change in OHI-S [Time frame: Baseline, 1 month, 3 months, and 6 months]
- Change in platelet count [Time frame: Baseline, 1 month, 3 months, and 6 months]
- Change in C-reactive protein (CRP) [Time frame: Baseline, 1 month, 3 months, and 6 months]
- Change in subgingival microbiome composition by 16S rRNA sequencing [Time frame: Baseline and 1 month]
- Radiographic change in alveolar bone status [Time frame: Baseline and 6 months]
Eligibility criteria
Inclusion criteria
- Kidney transplant recipients aged 18 years or older.
- Diagnosis of periodontitis according to the study case definition.
- Medically stable and able to undergo non-surgical periodontal treatment.
- Willing and able to provide written informed consent and attend follow-up visits.
Exclusion criteria
- \- Periodontal treatment or systemic antibiotic use within the predefined exclusion window in the protocol.
- Acute oral infection requiring urgent treatment.
- Pregnancy or lactation, if excluded by the approved protocol.
- Serious systemic condition or clinical instability judged by investigators to preclude study participation.
- Inability to comply with study procedures or follow-up schedule.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Vietnam · 2 centers
- 103 Military Hospital — Hanoi
- Vietnam Military Medical University — Hanoi
Identifiers
NCT: NCT07532694 · MH103-KTR-PERIOLASER-RCT-2026