Periodontal Status in Kidney Transplant Patients and the Effectiveness of Adjunctive Diode Laser Therapy
Phase: NA
Conditions: Periodontitis, Kidney Transplant Recipients
Sponsor: Military Hospital 103

MH103-KTR-PERIOLASER-RCT-2026 | Page 1 
STUDY PROTOCOL 
Diode Laser-Assisted Periodontal Therapy in Kidney 
Transplant Recipients 
Official Title 
Diode Laser-Assisted Periodontal Therapy in Kidney 
Transplant Recipients 
Unique Protocol ID 
MH103-KTR-PERIOLASER-RCT-2026 
NCT Number 
NCT number not yet assigned 
Protocol Version 
Version 1.0 
Document Date 
09 April 2026 
Sponsor / Responsible Institution Military Hospital 103 / Vietnam Military Medical 
University 
Study Setting 
Military Hospital 103, Hanoi, Vietnam 
1. Protocol Synopsis 
Item 
Description 
Study design 
Single-center study with two components: (1) a cross-sectional assessment 
of periodontal status in kidney transplant recipients and (2) a randomized 
controlled, parallel-group clinical trial in transplant recipients with mild-to-
moderate periodontitis. 
Population 
Adult kidney transplant recipients followed at Military Hospital 103; 
intervention phase limited to those with mild-to-moderate periodontitis and 
at least one functional sextant. 
Planned sample size 
80 participants total (40 per group), allowing for attrition from the 
minimum calculated sample size of 36 per group. 
Study arms 
Arm A: scaling and root planing (SRP) plus adjunctive diode laser therapy. 
Arm B: SRP alone. 
Follow-up 
Baseline, 1 month, 3 months, and 6 months after treatment.  
Main periodontal variables 
Plaque Index (PlI), Gingival Index (GI), Bleeding on Probing (BOP), 
Probing Depth (PD/PPD), Clinical Attachment Loss (CAL), Oral Hygiene 
Index-Simplified (OHI-S), and radiographic bone status. 
Laboratory / ancillary variables 
Blood tests (including CRP, urea, creatinine, and hematologic parameters), 
radiographs, and subgingival microbiological analysis using 16S rRNA-
based sequencing according to the proposal. 

MH103-KTR-PERIOLASER-RCT-2026 | Page 2 
Item 
Description 
Study duration 
December 2025 to June 2026 
2. Background and Rationale 
Periodontitis is a chronic inflammatory condition initiated by dysbiotic dental biofilm and characterized by 
destruction of the supporting tissues of the teeth. Kidney transplant recipients may be particularly vulnerable 
because of long-term immunosuppression, altered host defense, and frequent coexisting metabolic disorders. 
The uploaded proposal states that no Vietnamese study has systematically described periodontal status in 
kidney transplant recipients while also evaluating adjunctive diode laser therapy in this population. The study 
therefore combines an epidemiologic phase with a randomized treatment phase to address both disease burden 
and treatment response. 
Adjunctive diode laser therapy is expected to improve decontamination of periodontal pockets, reduce 
inflammation and bleeding, and support soft-tissue healing when added to standard non-surgical periodontal 
treatment. 
3. Objectives 
To evaluate the effectiveness of adjunctive diode laser therapy combined with SRP compared with SRP alone 
in kidney transplant recipients with periodontitis. 
Secondary objectives include describing radiographic and microbiological characteristics, exploring changes 
in selected laboratory biomarkers, and identifying factors associated with treatment response. 
4. Study Setting and Timeline 
This study will be conducted at the Department/Unit of Odonto-Stomatology and the transplant follow-up 
services of Military Hospital 103, Vietnam Military Medical University, Hanoi, Vietnam. 
Planned study period: December 2025 through June 2026. 
5. Study Design 
• This public study protocol describes the randomized, controlled, parallel-group interventional component 
only. Eligible kidney transplant recipients with mild-to-moderate periodontitis will be assigned to one of 
two treatment arms. 
• The trial is single-center. This operational method should be confirmed against the final approved 
randomization procedure before public posting. 
6. Participant Selection 
6.1 Inclusion Criteria 
• Diagnosed with end-stage kidney disease and previously treated with kidney transplantation. 
• Followed after kidney transplantation at Military Hospital 103. 
• At least 6 months post-transplant at the time of enrollment. 
• Able and willing to participate and provide written informed consent. 
• For the intervention phase: diagnosis of mild-to-moderate periodontitis, at least one functional sextant, and 
ability to complete periodontal treatment and follow-up. 

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• No periodontal treatment or systemic antibiotic therapy within 6 weeks before sample collection for the 
interventional component. 
6.2 Exclusion Criteria 
• Severe systemic disease judged by investigators to interfere with participation or interpretation of 
outcomes. 
• Severe periodontitis as operationally excluded in the proposal (including PD >= 7 mm and CAL >= 5 mm). 
• Previous recent treatment with diode laser or periodontal surgery within 6 weeks before enrollment. 
• Edentulous patients. 
• Inability to adhere to scheduled follow-up visits. 
• Refusal to participate. 
7. Enrollment, Allocation, and Study Arms 
Eligible participants for the interventional phase will be assigned to one of two groups after baseline 
examination. 
Arm 
Intervention 
Details 
Arm A 
SRP + diode laser 
Supragingival scaling, subgingival 
debridement/root planing, oral hygiene instruction, 
maintenance care, and adjunctive 810-nm diode 
laser therapy. 
Arm B 
SRP alone 
Supragingival scaling, subgingival 
debridement/root planing, oral hygiene instruction, 
and maintenance care without diode laser therapy. 
8. Interventions 
Standard periodontal therapy will include oral hygiene instruction, supragingival scaling, subgingival 
debridement, and root planing using routine periodontal instruments and ultrasonic devices, followed by 
maintenance care. 
The protocol proposal specifies use of an 810-nm diode laser as adjunctive therapy in the intervention arm. 
Device-specific settings and operating steps should match the final IRB-approved version and institutional 
device SOP before upload. 
The proposal also references repeat follow-up and maintenance visits; any concomitant mouthrinse or 
antibiotic regimen should be aligned with the final approved treatment manual and listed consistently across 
public and internal versions. 
9. Study Procedures and Assessments 
Assessment 
Baseline 
1 month 
3 months 
6 months 
Eligibility / consent 
X 
 
 
 
Medical and transplant 
history 
X 
 
 
 

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Assessment 
Baseline 
1 month 
3 months 
6 months 
Periodontal examination 
(PlI, GI, BOP, PD, CAL, 
OHI-S) 
X 
X 
X 
X 
Tooth mobility / clinical 
oral exam 
X 
X 
X 
X 
Radiographic assessment 
X 
 
 
X 
Blood tests (hematology / 
biochemistry incl. CRP, 
urea, creatinine) 
X 
X 
X 
X 
Subgingival microbiology 
/ 16S rRNA sequencing 
X 
X 
 
 
Periodontal treatment / 
maintenance 
X 
X 
X 
X 
 
10. Outcome Measures 
• Change in periodontal probing depth from baseline to follow-up visits. 
• Change in clinical attachment loss from baseline to follow-up visits. 
• Change in gingival inflammation and bleeding parameters (GI and BOP). 
• Changes in plaque control and oral hygiene indices (PlI and OHI-S). 
• Radiographic change in alveolar bone status. 
• Changes in selected laboratory biomarkers, including CRP and renal-function-related markers. 
• Change in subgingival microbial profile based on molecular testing. 
11. Sample Size 
For the interventional phase, the proposal uses a two-group comparison with p1 = 0.50, p2 = 0.75, alpha = 
0.05, and beta = 0.20, yielding 36 participants per group. The planned operational sample is 40 participants 
per group (80 total). 
12. Statistical Analysis Plan (integrated summary) 
Descriptive statistics will summarize demographic, transplant-related, clinical, radiographic, laboratory, and 
microbiological variables. 
Compare changes over time within groups and between groups using statistical tests appropriate to variable 
type and distribution. Repeated-measures approaches may be used for longitudinal outcomes as defined in the 
final analysis plan. 
All statistical testing will be two-sided with a nominal significance threshold of 0.05 unless otherwise 
specified in the final approved SAP. 

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13. Safety Monitoring and Adverse Events 
This study involves non-surgical periodontal treatment and adjunctive diode laser therapy, both of which may 
cause transient discomfort, tooth sensitivity, mild bleeding, or soft-tissue irritation. 
Participants will be observed during and after procedures, and clinically important adverse events will be 
documented and managed according to institutional practice. Kidney transplant recipients will continue 
routine transplant follow-up and immunosuppressive management through their treating physicians. 
Any serious or unexpected event will be reported according to institutional ethics requirements and local 
regulations. 
14. Data Collection, Confidentiality, and Quality Control 
Study data will be recorded on study forms and in secure research files using coded identifiers. No participant 
names should appear in any public document uploaded to ClinicalTrials.gov. 
Only authorized research personnel will have access to identifiable information. Public-facing documents will 
contain no directly identifying participant information. 
Clinical measurements should be performed using standardized periodontal methods and calibrated examiners 
whenever applicable. 
15. Ethics 
The study was approved by Ethics Committee in Biomedical Research, Vietnam Military Medical University 
(Approval No. 119/CNChT-HĐĐĐ). Written informed consent will be obtained from all participants before 
any study-specific procedures. 
16. Publication and Public Posting 
This protocol is intended for public posting as a study document. Public and internal versions should remain 
materially consistent regarding objectives, design, eligibility, interventions, and outcome measures. 
Any later substantive amendment should be reflected in both the local master protocol and the public 
document version as appropriate.