Photoablative-photodynamic (PAPD) Diode Laser Therapy Adjunctive to Scaling and Root Planing in Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- PD
研究概览
简要总结
The purpose of this study is to compare the efficacy of photoablative and photodynamic diode laser in adjunct to scaling-root planing (PAPD+SRP) and SRP alone for the treatment of periodontitis.
详细描述
The present study is a randomized, blinded, controlled clinical trial, which used a split-mouth design. All patients were informed individually about the nature of the proposed treatment, and informed consent forms were signed. Twenty-four patients were studied. Maxillary left or right quadrants were randomly assigned to PAPD laser treatment or sham-treatment and SRP. PAPD consisted of: i) photoablative gingival epithelium with diode laser (λ 810 nm, 1 W); ii) photodynamic treatments (4-10 weekly) with diode laser (λ 635 nm, 100 mW) and 0.3% methylene blue as photoactive antiseptic, performed after SRP. Sham-treatment was similar but with switched off laser.
Efficacy evaluations, including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP) was performed at baseline ,1year, and year 3 using a conventional manual periodontal probe. Polymorphonuclear leukocytes (PMN), erythrocytes (RBC), damaged epithelial cells (DEC) and bacteria were assayed by cytofluorescence on gingival exfoliative samples at baseline, 6 month and 1, 3, 5 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Periodontitis:Presence of at least two teeth with at least one site with pocket probing depth (PD) ranging from 4 to 10 mm in each upper maxillary quadrant and with bleeding on probing (BOP)
- •A minimum of five natural teeth in each studied quadrant.
排除标准
- •History of systemic diseases (diabetes mellitus, cancer, HIV, metabolic and endocrine diseases)
- •Pregnancy or lactation
- •Chronic high-dose steroid use
- •Previous or current radiation or immunosuppressive therapies
- •Ongoing orthodontic treatments
- •Extensive carious lesions
- •Recurrent antibiotic medications during the 6 months preceding the study
- •Class III tooth mobility
- •Heavy contamination by spirochetes and fungal pathogens on tongue and oral mucosa
研究组 & 干预措施
PAPD+SRP Quadrant
This quadrant, randomly selected in each patients, undergoes treatment with PAPD+ SRP
干预措施: PAPD+SRP (Procedure)
Sham-laser + SRP
This quadrant, randomly selected in each patients, undergoes treatment with sham-laser + SRP
干预措施: Sham-laser +SRP (Procedure)
结局指标
主要结局
PD
时间窗: baseline, 1 year
Change in probing pocket depth
次要结局
- Patient-reported outcomes(baseline, 1 year)
- CAL(baseline, 1 year)
- BoP(baseline, 1 year)
- PMN, DEC, bacteria(baseline, 1 year)