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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SRP + diode laser | Experimental | Participants receive full-mouth scaling and root planing combined with adjunctive diode laser treatment according to the study protocol. |
|
| SRP alone | Active Comparator | Participants receive full-mouth scaling and root planing alone according to the study protocol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scaling and Root Planing | Procedure | Conventional non-surgical periodontal therapy performed according to the study protocol in both groups. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in clinical attachment level (CAL) | Mean change in CAL, measured in millimeters. | Baseline, 1 month, 3 months, and 6 months |
| Change in probing pocket depth (PPD) | Mean change in CAL, measured in millimeters. | Baseline, 1 month, 3 months, and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in bleeding on probing (BOP) | Percentage of sites with BOP. | Baseline, 1 month, 3 months, and 6 months |
| Change in gingival index (GI) | Mean GI score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thang V Dinh, Principal Investigator | Contact | +84971349066 | bsdinhthang277@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 103 Military Hospital | Recruiting | Hanoi | Hadong | 100000 | Vietnam |
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| Label | URL |
|---|---|
| Related Info | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 9, 2026 | Apr 9, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D014080 | Tooth Exfoliation |
| D016745 | Root Planing |
| D054023 | Lasers, Semiconductor |
| ID | Term |
|---|---|
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
| D012534 | Dental Scaling |
| D003777 | Dental Prophylaxis |
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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.
| Diode Laser | Device | 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. |
|
| Baseline, 1 month, 3 months, and 6 months |
| Change in plaque index (PlI) | Mean plaque index score. | Baseline, 1 month, 3 months, and 6 months |
| Change in OHI-S | Mean simplified oral hygiene index score. | Baseline, 1 month, 3 months, and 6 months |
| Change in platelet count | Platelet count from peripheral blood test. | Baseline, 1 month, 3 months, and 6 months |
| Change in C-reactive protein (CRP) | CRP concentration. | 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. | Baseline and 1 month |
| Radiographic change in alveolar bone status | Radiographic change in alveolar bone status assessed according to the study imaging protocol | Baseline and 6 months |
| Vietnam Military Medical University | Recruiting | Hanoi | QUẬN HÀ ĐÔNG | 100000 | Vietnam |
|
| D010517 | Periodontics |
| D003813 | Dentistry |
| D013357 | Subgingival Curettage |
| D011313 | Preventive Dentistry |
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |