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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 9, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 9, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 9, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 16, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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