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RecruitingNCT07532694KTRsUpdated Apr 16, 2026

Diode Laser-Assisted Periodontal Therapy in Kidney Transplant Recipients

An interventional study of Scaling and Root Planing and Diode Laser in Periodontitis and Kidney Transplant Recipients, sponsored by Military Hospital 103. Recruiting at 2 sites in Vietnam. Per ClinicalTrials.gov, last updated 2026-04-16.

Sponsored by Military Hospital 103 · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Periodontitis
  • Kidney Transplant Recipients

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Keywords

  • diode laser
  • scaling and root planing
  • periodontal therapy
  • kidney transplantation
  • 16S rRNA
  • microbiome
  • C-reactive protein
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • 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 · Device: Diode Laser

  • Active comparator
    SRP alone

    Participants receive full-mouth scaling and root planing alone according to the study protocol

    Procedure: Scaling and Root Planing

Interventions

  • ProcedureScaling and Root Planing

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

  • DeviceDiode 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.

05

What researchers measure

Primary outcomes

  1. Change in clinical attachment level (CAL)

    Mean change in CAL, measured in millimeters.

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

  2. Change in probing pocket depth (PPD)

    Mean change in CAL, measured in millimeters.

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

Secondary outcomes

  1. Change in bleeding on probing (BOP)

    Percentage of sites with BOP.

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

  2. Change in gingival index (GI)

    Mean GI score

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

  3. Change in plaque index (PlI)

    Mean plaque index score.

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

  4. Change in OHI-S

    Mean simplified oral hygiene index score.

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

  5. Change in platelet count

    Platelet count from peripheral blood test.

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

  6. Change in C-reactive protein (CRP)

    CRP concentration.

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

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

    Relative abundance and diversity metrics of subgingival microbiota.

    Time frame: Baseline and 1 month

  8. Radiographic change in alveolar bone status

    Radiographic change in alveolar bone status assessed according to the study imaging protocol

    Time frame: Baseline and 6 months

06

Study locations

2 of 2 sites recruiting
  • 103 Military Hospital
    Hanoi, Hadong 100000, Vietnam
    Recruiting
  • Vietnam Military Medical University
    Hanoi, QUẬN HÀ ĐÔNG 100000, Vietnam
    Recruiting
07

References and documents

Related links

Study documents

  • Study protocol · Apr 9, 2026

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT07532694
Lead sponsor
Military Hospital 103
Responsible party
VietThang Dinh (Principal Investigator, Military Hospital 103) — Principal investigator
First posted
Apr 16, 2026
Start date
Dec 9, 2025
Primary completion
Jun 9, 2026 (estimated)
Completion
Jun 9, 2026 (estimated)
Last update
Apr 16, 2026

Study contacts

Thang V Dinh, Principal Investigator
Contact
bsdinhthang277@gmail.com
+84971349066

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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