PeriodontitisKTRsNCT07532694
Diode Laser-Assisted Periodontal Therapy in Kidney Transplant Recipients
A study testing Scaling and Root Planing and Diode Laser in people with Periodontitis and Kidney Transplant Recipients, run by Military Hospital 103 at 2 sites in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Kidney Transplant Recipients
- What is being tested?
- Scaling and Root Planing and Diode Laser
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesVietnam
- Study dates
- 9 Dec 2025to 9 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- - 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Vietnam2 sites, 2 recruiting
- Recruiting
103 Military Hospital
Hanoi, Hadong, 100000
Thang V Dinh, Principal Investigator, +84971349066, bsdinhthang277@gmail.com
- Recruiting
Vietnam Military Medical University
Hanoi, QUẬN HÀ ĐÔNG, 100000
Thang V Dinh, Principal Investigator, +84971349066, bsdinhthang277@gmail.com
About this study
Official title: Periodontal Status in Kidney Transplant Patients and the Effectiveness of Adjunctive Diode Laser Therapy
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.
- Conditions
- Periodontitis, Kidney Transplant Recipients
- Being tested
- Scaling and Root Planing, Diode Laser
- Keywords
- diode laser, scaling and root planing, periodontal therapy, kidney transplantation, 16S rRNA, microbiome, C-reactive protein
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaling and Root PlaningProcedure or surgery
Conventional non-surgical periodontal therapy performed according to the study protocol in both groups.
Diode LaserDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| SRP + diode laser | Experimental | Participants receive full-mouth scaling and root planing combined with adjunctive diode laser treatment according to the study protocol. Receives: Procedure: Scaling and Root Planing; Device: Diode Laser |
| SRP alone | Active comparator | Participants receive full-mouth scaling and root planing alone according to the study protocol Receives: Procedure: Scaling and Root Planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in clinical attachment level (CAL)
Mean change in CAL, measured in millimeters.
Measured: Baseline, 1 month, 3 months, and 6 months
Change in probing pocket depth (PPD)
Mean change in CAL, measured in millimeters.
Measured: Baseline, 1 month, 3 months, and 6 months
Secondary outcomes (8)
Change in bleeding on probing (BOP)
Percentage of sites with BOP.
Measured: Baseline, 1 month, 3 months, and 6 months
Change in gingival index (GI)
Mean GI score
Measured: Baseline, 1 month, 3 months, and 6 months
Change in plaque index (PlI)
Mean plaque index score.
Measured: Baseline, 1 month, 3 months, and 6 months
Change in OHI-S
Mean simplified oral hygiene index score.
Measured: Baseline, 1 month, 3 months, and 6 months
Change in platelet count
Platelet count from peripheral blood test.
Measured: Baseline, 1 month, 3 months, and 6 months
Change in C-reactive protein (CRP)
CRP concentration.
Measured: Baseline, 1 month, 3 months, and 6 months
Change in subgingival microbiome composition by 16S rRNA sequencing
Relative abundance and diversity metrics of subgingival microbiota.
Measured: Baseline and 1 month
Radiographic change in alveolar bone status
Radiographic change in alveolar bone status assessed according to the study imaging protocol
Measured: Baseline and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start9 Dec 2025
- Primary completion9 Jun 2026 (estimated)
- Study completion9 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Military Hospital 103
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, VietThang Dinh, Military Hospital 103
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07532694
- Sponsor's protocol ID
- MH103-KTR-PERIOLASER-RCT-2026
- Acronym
- KTRs
- Status last verified
- Apr 2026
- First submitted
- 2 Apr 2026
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontal Status in Kidney Transplant Patients and the Effectiveness of Adjunctive Diode Laser Therapy
- ClinicalTrials.gov ID
- NCT07532694
- Acronym / sponsor ID
- KTRs / MH103-KTR-PERIOLASER-RCT-2026
- Conditions
- Periodontitis, Kidney Transplant Recipients
- Keywords
- diode laser, scaling and root planing, periodontal therapy, kidney transplantation, 16S rRNA, microbiome, C-reactive protein
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Military Hospital 103University, hospital or other
- Study start
- 9 Dec 2025 (actual)
- Primary completion
- 9 Jun 2026 (estimated)
- Study completion
- 9 Jun 2026 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SRP + diode laser | Experimental | Procedure: Scaling and Root Planing, Device: Diode LaserParticipants receive full-mouth scaling and root planing combined with adjunctive diode laser treatment according to the study protocol. |
| SRP alone | Active comparator | Procedure: Scaling and Root PlaningParticipants receive full-mouth scaling and root planing alone according to the study protocol |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- - 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scaling and Root PlaningConventional non-surgical periodontal therapy performed according to the study protocol in both groups. | Procedure or surgery | SRP + diode laser, SRP alone |
| Diode LaserAdjunctive 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. | Device | SRP + diode laser |
Primary outcome
Change in clinical attachment level (CAL)
Time frame: Baseline, 1 month, 3 months, and 6 months
Mean change in CAL, measured in millimeters.
Change in probing pocket depth (PPD)
Time frame: Baseline, 1 month, 3 months, and 6 months
Mean change in CAL, measured in millimeters.
8 secondary outcomes
Change in bleeding on probing (BOP)
Time frame: Baseline, 1 month, 3 months, and 6 months
Change in gingival index (GI)
Time frame: Baseline, 1 month, 3 months, and 6 months
Change in plaque index (PlI)
Time frame: Baseline, 1 month, 3 months, and 6 months
Change in OHI-S
Time frame: Baseline, 1 month, 3 months, and 6 months
Change in platelet count
Time frame: Baseline, 1 month, 3 months, and 6 months
Change in C-reactive protein (CRP)
Time frame: Baseline, 1 month, 3 months, and 6 months
Change in subgingival microbiome composition by 16S rRNA sequencing
Time frame: Baseline and 1 month
Radiographic change in alveolar bone status
Time frame: Baseline and 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scaling and Root Planing and Diode Laser in people with Periodontitis and Kidney Transplant Recipients, run by Military Hospital 103 at 2 sites in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thang V Dinh, Principal Investigator (+84971349066, bsdinhthang277@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in clinical attachment level (CAL) (time frame: Baseline, 1 month, 3 months, and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.