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This randomized controlled trial (RCT) aims to evaluate the clinical efficacy of Nd:YAG laser adjunctive therapy and its impact on the subgingival microbiome in patients with stage III-IV periodontitis. The study addresses two key questions: (1) Whether Nd:YAG laser combined with scaling and root planing (SRP) yields significantly greater improvements in periodontal parameters compared to SRP alone; and (2) How subgingival microbial dynamics correlate with therapeutic outcomes.
Participants were randomized into two groups: the SRP group (mechanical debridement only) and the Nd group (mechanical debridement with Nd:YAG laser therapy). Clinical parameters-including probing depth (PD), clinical attachment level (CAL), and gingival index (GI)-were assessed at baseline and 3 months post-treatment. Subgingival plaque samples were analyzed via 16S rDNA sequencing to characterize microbial community shifts.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nd group | Experimental | The Nd group received comprehensive periodontal therapy combining scaling and root planing (SRP) with adjunctive Nd:YAG laser treatment. |
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| SRP group | Active Comparator | The SRP group received standard periodontal therapy consisting of scaling and root planing (SRP) alone, serving as the active control for comparison against laser-assisted treatment. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SRP | Procedure | Full-mouth scaling and root planing (SRP) was performed using an ultrasonic scaler (EMS AIR-FLOW MASTER PIEZON®) supplemented by Gracey curettes for subgingival instrumentation. All procedures were conducted under local anesthesia by a calibrated periodontist, with each quadrant treated for a minimum of 30 minutes. Patients received standardized oral hygiene instructions and were scheduled for a 3-month postoperative follow-up. |
| Measure | Description | Time Frame |
|---|---|---|
| Alpha diversity of subgingival microbiota | The higher the alpha diversity, the greater the species richness and evenness of the microbial community. | From enrollment to the end of treatment at 3 months |
| Probing Depth | Probing depth (PD) measures the distance from the gingival margin to the base of the periodontal pocket, clinically assessing periodontal attachment loss and tissue destruction. | From enrollment to the end of treatment at 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Beta diversity of subgingival microbiota | Beta diversity reflects the similarity in species composition. | From enrollment to the end of treatment at 3 months |
| Composition of subgingival microbiota |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Sun Yat-sen University | Guangzhou | Guangdong | 510000 | China |
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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 | Aug 16, 2024 | Jun 30, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 16, 2024 | Jun 30, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ND | Procedure | In addition to the identical SRP protocol described above, adjunctive Nd:YAG laser therapy (Wiser Waterlase MD, Vista Dental) was applied immediately post-SRP. Laser parameters were set at 150 mJ/pulse, 20 Hz frequency with water (level 1) and air (level 3) coolant. The fiber optic tip (300 μm diameter) was moved in a continuous "Zig-zag" pattern along the root surface and pocket epithelium, maintaining 2-second irradiation per site at a 30° angle to the tooth axis. Standardized oral hygiene instructions and 3-month follow-up were similarly provided. |
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The composition of subgingival microbiota refers to the taxonomic structure and relative abundance of bacterial species within the periodontal pocket biofilm, which plays a critical role in periodontal health and disease progression.
| From enrollment to the end of treatment at 3 months |
| Microbial phenotypes of subgingival microbiota | The microbial phenotypes of subgingival microbiota encompass the functional and metabolic characteristics of periodontal biofilm communities, including virulence factors, antibiotic resistance profiles, and synergistic interactions that contribute to periodontal pathogenesis. | From enrollment to the end of treatment at 3 months |
| Clinical Attachment Level (CAL) | Clinical Attachment Level (CAL) measures the distance from the cementoenamel junction (CEJ) to the base of the periodontal pocket, directly quantifying periodontal tissue destruction and tooth-supporting structure loss. | From enrollment to the end of treatment at 3 months |
| Gingival Index (GI) | The Gingival Index (GI) assesses the severity of gingival inflammation through standardized scoring of redness, swelling, and bleeding tendency, providing a quantitative measure of periodontal tissue health. | From enrollment to the end of treatment at 3 months |
| Plaque Index (PI) | The Plaque Index (PI) quantifies the extent of bacterial plaque accumulation on tooth surfaces, using standardized scoring systems to assess oral hygiene status and periodontal disease risk. | From enrollment to the end of treatment at 3 months |
| Bleeding on Probing (BOP) | Bleeding on Probing (BOP) evaluates gingival inflammation by recording the presence/absence of bleeding within 30 seconds after gentle periodontal probing, serving as a key diagnostic indicator of active periodontal disease. | From enrollment to the end of treatment at 3 months |