Periodontitis
Conditions
Brief summary
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.
Interventions
PROCEDURESRP
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.
PROCEDUREND
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.
Sponsors
Rui He
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Aged 18-80 years * Minimum of 14 remaining natural teeth * Diagnosis of Stage III-IV periodontitis according to the 2018 World Workshop classification system * No periodontal treatment within the past 6 months * Willing to provide informed consent and participate in the study protocol
Exclusion criteria
* Presence of systemic conditions that may affect periodontal treatment outcomes (e.g., uncontrolled hypertension \[\>140/90 mmHg\], diabetes mellitus \[HbA1c \>7%\]) * Use of antibiotics or medications known to induce gingival enlargement (e.g., calcium channel blockers, phenytoin) within the past 3 months * Coagulation disorders or hematologic diseases * Active systemic infections * Pregnancy or lactation * Acute periodontal lesions * Inability to comply with study protocols
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Alpha diversity of subgingival microbiota | From enrollment to the end of treatment at 3 months | The higher the alpha diversity, the greater the species richness and evenness of the microbial community. |
| Probing Depth | From enrollment to the end of treatment at 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Microbial phenotypes of subgingival microbiota | From enrollment to the end of treatment at 3 months | 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. |
| Clinical Attachment Level (CAL) | From enrollment to the end of treatment at 3 months | 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. |
| Beta diversity of subgingival microbiota | From enrollment to the end of treatment at 3 months | Beta diversity reflects the similarity in species composition. |
| Plaque Index (PI) | From enrollment to the end of treatment at 3 months | 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. |
| Bleeding on Probing (BOP) | From enrollment to the end of treatment at 3 months | 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. |
| Gingival Index (GI) | From enrollment to the end of treatment at 3 months | 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. |
| Composition of subgingival microbiota | From enrollment to the end of treatment at 3 months | 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. |
Countries
China
Outcome results
None listed