Kidney Transplant Recipients, Periodontitis
Conditions
Keywords
diode laser, scaling and root planing, periodontal therapy, kidney transplantation, 16S rRNA, microbiome, C-reactive protein
Brief 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.
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
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.
Sponsors
Military Hospital 103
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Single or double masking only if the protocol truly supports it; otherwise choose None (Open Label). Recommended: Outcomes Assessor masked, if examiner blinding is feasible.
Eligibility
Sex/Gender
ALL
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
* \- 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in clinical attachment level (CAL) | Baseline, 1 month, 3 months, and 6 months | Mean change in CAL, measured in millimeters. |
| Change in probing pocket depth (PPD) | Baseline, 1 month, 3 months, and 6 months | Mean change in CAL, measured in millimeters. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in bleeding on probing (BOP) | Baseline, 1 month, 3 months, and 6 months | Percentage of sites with BOP. |
| Change in gingival index (GI) | Baseline, 1 month, 3 months, and 6 months | Mean GI score |
| Change in plaque index (PlI) | Baseline, 1 month, 3 months, and 6 months | Mean plaque index score. |
| Change in OHI-S | Baseline, 1 month, 3 months, and 6 months | Mean simplified oral hygiene index score. |
| Change in platelet count | Baseline, 1 month, 3 months, and 6 months | Platelet count from peripheral blood test. |
| Change in C-reactive protein (CRP) | Baseline, 1 month, 3 months, and 6 months | CRP concentration. |
| Change in subgingival microbiome composition by 16S rRNA sequencing | Baseline and 1 month | Relative abundance and diversity metrics of subgingival microbiota. |
| Radiographic change in alveolar bone status | Baseline and 6 months | Radiographic change in alveolar bone status assessed according to the study imaging protocol |
Countries
Vietnam
Contacts
CONTACTThang V Dinh, Principal Investigator
Outcome results
None listed