Characteristics of Subgingival Microbiota in Patients With Stage III-IV Periodontitis in Response to Nd:YAG Laser-Assisted Therapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 240
- 试验地点
- 1
- 主要终点
- Alpha diversity of subgingival microbiota
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Nd group
The Nd group received comprehensive periodontal therapy combining scaling and root planing (SRP) with adjunctive Nd:YAG laser treatment.
干预措施: ND (Procedure)
SRP group
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.
干预措施: SRP (Procedure)
结局指标
主要结局
Alpha diversity of subgingival microbiota
时间窗: 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
时间窗: 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.
次要结局
- Beta diversity of subgingival microbiota(From enrollment to the end of treatment at 3 months)
- Composition of subgingival microbiota(From enrollment to the end of treatment at 3 months)
- Microbial phenotypes of subgingival microbiota(From enrollment to the end of treatment at 3 months)
- Clinical Attachment Level (CAL)(From enrollment to the end of treatment at 3 months)
- Gingival Index (GI)(From enrollment to the end of treatment at 3 months)
- Plaque Index (PI)(From enrollment to the end of treatment at 3 months)
- Bleeding on Probing (BOP)(From enrollment to the end of treatment at 3 months)
研究者
Rui He
Resident Physician
First Affiliated Hospital, Sun Yat-Sen University