Periodontal Status in Kidney Transplant Patients and the Effectiveness of Adjunctive Diode Laser Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change in clinical attachment level (CAL)
研究概览
简要总结
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.
详细描述
- 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.
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)
盲法说明
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.
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •- 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.
研究组 & 干预措施
SRP + diode laser
Participants receive full-mouth scaling and root planing combined with adjunctive diode laser treatment according to the study protocol.
干预措施: Scaling and Root Planing (Procedure)
SRP + diode laser
Participants receive full-mouth scaling and root planing combined with adjunctive diode laser treatment according to the study protocol.
干预措施: Diode Laser (Device)
SRP alone
Participants receive full-mouth scaling and root planing alone according to the study protocol
干预措施: Scaling and Root Planing (Procedure)
结局指标
主要结局
Change in clinical attachment level (CAL)
时间窗: Baseline, 1 month, 3 months, and 6 months
Mean change in CAL, measured in millimeters.
Change in probing pocket depth (PPD)
时间窗: Baseline, 1 month, 3 months, and 6 months
Mean change in CAL, measured in millimeters.
次要结局
- Change in bleeding on probing (BOP)(Baseline, 1 month, 3 months, and 6 months)
- Change in gingival index (GI)(Baseline, 1 month, 3 months, and 6 months)
- Change in plaque index (PlI)(Baseline, 1 month, 3 months, and 6 months)
- Change in OHI-S(Baseline, 1 month, 3 months, and 6 months)
- Change in platelet count(Baseline, 1 month, 3 months, and 6 months)
- Change in C-reactive protein (CRP)(Baseline, 1 month, 3 months, and 6 months)
- Change in subgingival microbiome composition by 16S rRNA sequencing(Baseline and 1 month)
- Radiographic change in alveolar bone status(Baseline and 6 months)
研究者
VietThang Dinh
Principal Investigator
Military Hospital 103