Diode Laser-Assisted Periodontal Therapy in Kidney Transplant Recipients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorMilitary Hospital 103
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
- 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.
Trial design
Design model
Parallel
Treatments tested in this trial
Scaling and Root Planing
Procedure/SurgeryConventional non-surgical periodontal therapy performed according to the study protocol in both groups.
Diode Laser
DeviceAdjunctive 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.
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: SRP + diode laserExperimental treatment 2 interventions
Group B: SRP aloneActive comparator 1 intervention
Trial outcomes
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 months2
Change in probing pocket depth (PPD)
Mean change in CAL, measured in millimeters.
Time frame
Baseline, 1 month, 3 months, and 6 monthsSecondary outcomes
1
Change in bleeding on probing (BOP)
Percentage of sites with BOP.
Time frame
Baseline, 1 month, 3 months, and 6 months2
Change in gingival index (GI)
Mean GI score
Time frame
Baseline, 1 month, 3 months, and 6 months3
Change in plaque index (PlI)
Mean plaque index score.
Time frame
Baseline, 1 month, 3 months, and 6 months4
Change in OHI-S
Mean simplified oral hygiene index score.
Time frame
Baseline, 1 month, 3 months, and 6 monthsSponsors and contacts
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Source ClinicalTrials.gov