Diode Laser-Assisted Periodontal Therapy in Kidney Transplant Recipients (KTRs)

April 9, 2026 updated by: VietThang Dinh, Military Hospital 103

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Vietnam
    • Hadong
      • Hanoi, Hadong, Vietnam, 100000
        • Recruiting
        • 103 Military Hospital
        • Contact:
    • QUẬN HÀ ĐÔNG
      • Hanoi, QUẬN HÀ ĐÔNG, Vietnam, 100000
        • Recruiting
        • Vietnam Military Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SRP + diode laser
Participants receive full-mouth scaling and root planing combined with adjunctive diode laser treatment according to the study protocol.
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.
Active Comparator: SRP alone
Participants receive full-mouth scaling and root planing alone according to the study protocol
Procedure: Scaling and Root Planing
Conventional non-surgical periodontal therapy performed according to the study protocol in both groups.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in clinical attachment level (CAL)
Time Frame: Baseline, 1 month, 3 months, and 6 months
Mean change in CAL, measured in millimeters.
Baseline, 1 month, 3 months, and 6 months
Change in probing pocket depth (PPD)
Time Frame: Baseline, 1 month, 3 months, and 6 months
Mean change in CAL, measured in millimeters.
Baseline, 1 month, 3 months, and 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in bleeding on probing (BOP)
Time Frame: Baseline, 1 month, 3 months, and 6 months
Percentage of sites with BOP.
Baseline, 1 month, 3 months, and 6 months
Change in gingival index (GI)
Time Frame: Baseline, 1 month, 3 months, and 6 months
Mean GI score
Baseline, 1 month, 3 months, and 6 months
Change in plaque index (PlI)
Time Frame: Baseline, 1 month, 3 months, and 6 months
Mean plaque index score.
Baseline, 1 month, 3 months, and 6 months
Change in OHI-S
Time Frame: Baseline, 1 month, 3 months, and 6 months
Mean simplified oral hygiene index score.
Baseline, 1 month, 3 months, and 6 months
Change in platelet count
Time Frame: Baseline, 1 month, 3 months, and 6 months
Platelet count from peripheral blood test.
Baseline, 1 month, 3 months, and 6 months
Change in C-reactive protein (CRP)
Time Frame: Baseline, 1 month, 3 months, and 6 months
CRP concentration.
Baseline, 1 month, 3 months, and 6 months
Change in subgingival microbiome composition by 16S rRNA sequencing
Time Frame: Baseline and 1 month
Relative abundance and diversity metrics of subgingival microbiota.
Baseline and 1 month
Radiographic change in alveolar bone status
Time Frame: Baseline and 6 months
Radiographic change in alveolar bone status assessed according to the study imaging protocol
Baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Military Hospital 103

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2025

Primary Completion (Estimated)

June 9, 2026

Study Completion (Estimated)

June 9, 2026

Study Registration Dates

First Submitted

April 2, 2026

First Submitted That Met QC Criteria

April 9, 2026

First Posted (Actual)

April 16, 2026

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 9, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MH103-KTR-PERIOLASER-RCT-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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