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NCT Number: NCT07532694

Diode Laser-Assisted Periodontal Therapy in Kidney Transplant Recipients

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.

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Key information

Conditions

Periodontitis Kidney Transplant Recipients Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

103 Military Hospital, Hanoi, Hadong, Vietnam

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About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Scaling and Root Planing

Procedure

Conventional non-surgical periodontal therapy performed according to the study protocol in both groups.

Diode laser

Device

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 outcomes

  1. Change in clinical attachment level (CAL)

    Time frame: Baseline, 1 month, 3 months, and 6 months

    Mean change in CAL, measured in millimeters.

  2. Change in probing pocket depth (PPD)

    Time frame: Baseline, 1 month, 3 months, and 6 months

    Mean change in CAL, measured in millimeters.

Secondary outcomes

  1. Change in bleeding on probing (BOP)

    Time frame: Baseline, 1 month, 3 months, and 6 months

    Percentage of sites with BOP.

  2. Change in gingival index (GI)

    Time frame: Baseline, 1 month, 3 months, and 6 months

    Mean GI score

  3. Change in plaque index (PlI)

    Time frame: Baseline, 1 month, 3 months, and 6 months

    Mean plaque index score.

  4. Change in OHI-S

    Time frame: Baseline, 1 month, 3 months, and 6 months

    Mean simplified oral hygiene index score.

  5. Change in platelet count

    Time frame: Baseline, 1 month, 3 months, and 6 months

    Platelet count from peripheral blood test.

  6. Change in C-reactive protein (CRP)

    Time frame: Baseline, 1 month, 3 months, and 6 months

    CRP concentration.

  7. Change in subgingival microbiome composition by 16S rRNA sequencing

    Time frame: Baseline and 1 month

    Relative abundance and diversity metrics of subgingival microbiota.

  8. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Thang V Dinh, Principal Investigator

CONTACT

[email protected]

+84971349066

Sponsors and collaborators

Lead sponsor

Military Hospital 103

Other

Registry information

Official study title

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

Acronym: KTRs

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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