Adjuvant Effect of Antimicrobial Photodynamic Therapy on Periodontal Treatment and Salivary Status of Type 1 Diabetes Mellitus Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Salivary glucose - collection of stimulated saliva in 10 minutes and measured with a colorimetric kit
研究概览
简要总结
The aim of this study is to evaluate adjuvant effect of antimicrobial photodynamic therapy in periodontal treatment and salivary status of type 1 diabetes patients.
详细描述
Diabetes Mellitus is a risk factor for periodontal disease increasing its prevalence, extension and severity. Periodontal disease is considered the sixth complication of diabetes. There is a global epidemic of diabetes, including an increase of type 1 diabetes incidence in younger patients. Adjuvant treatments to scaling and root planing as antimicrobial photodynamic therapy show improved clinical outcomes. Thus, the aim of this randomized clinical trial is to evaluate adjuvant effect of antimicrobial photodynamic therapy in periodontal treatment and salivary status of type 1 diabetes patients.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnose of Type 1 diabetes mellitus
- •Age between 18 to 65 years old
- •Presence of at least one tooth for hemiarch
- •Moderate and severe periodontal disease
排除标准
- •Type 2 diabetes mellitus
- •Total edentulism
- •Pregnancy
- •Systemic diseases as other endocrine diseases and blood diseases
- •Use of drugs that alter periodontal tissue as phenytoin and cyclosporine
研究组 & 干预措施
Scaling Root Planing
Treatment by scaling and root planing. Repetition after 7 and 14 days.
干预措施: Scaling root planing (Procedure)
Antimicrobial Photodynamic Therapy
Scaling and root planing and Antimicrobial photodynamic therapy with red laser (658 nm, 0.1 Watts, 2229 J/cm², 10s per point) and methylene blue dye (10mg/ml). Repetition after 7 and 14 days.
干预措施: Scaling root planing (Procedure)
Antimicrobial Photodynamic Therapy
Scaling and root planing and Antimicrobial photodynamic therapy with red laser (658 nm, 0.1 Watts, 2229 J/cm², 10s per point) and methylene blue dye (10mg/ml). Repetition after 7 and 14 days.
干预措施: Antimicrobial photodynamic therapy (Procedure)
结局指标
主要结局
Salivary glucose - collection of stimulated saliva in 10 minutes and measured with a colorimetric kit
时间窗: 6 months
Salivary glucose is measured by a colorimetric kit and the values are converted and presented as mg/dL. There are no reference value for this measurement. The analysis is done by means of correlation to blood glucose levels in mg/dL.
Periodontal disease (gingivitis and periodontitis) measured by a periodontal probe and classified according to severity
时间窗: 6 months
Severe periodontitis was defined by the presence of ≥ 2 interproximal sites in different teeth with clinical attachment level (CAL) ≥ 6mm and ≥1 interproximal site with periodontal probing depth (PPD) ≥5mm. Moderate periodontitis was defined by the presence of ≥ 2 interproximal sites in different teeth with CAL ≥ 4mm or ≥ 2 interproximal sites in different teeth with PPD ≥5mm. Mild periodontitis was defined as ≥ 2 interproximal sites in different teeth with ≥ 3 mm CAL and ≥ 2 interproximal sites in different teeth with ≥ 4 mm PPD or at least 1 site with PPD ≥ 5 mm (20,21). Gingivitis was determined as follows: Subjects were considered healthy if presented PPD ≤3mm/Bleeding on probing (BOP) extent scores \< 10% and with gingivitis if presented PPD ≤3mm/ BOP extent scores \>10%.
次要结局
- Capillary glycemia measured by a glucometer(6 months)
- Salivary pH and buffering Capacity - collection of stimulated saliva in 10 minutes and measurement of acidity with a pHmeter(6 months)
研究者
Carla Andreotti Damante
Associate professor
University of Sao Paulo