Indocyanine-mediated Antimicrobial Photodynamic Therapy Promotes Superior Clinical Effects in Stage III and Grade C Chronic Periodontitis Among Different Forms of Diabetes Mellitus: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Clinical attachment level
研究概览
简要总结
With this design, this study hypothesizes that; (i) ICG-PDT would produce superior clinical, microbiological, and immune-inflammatory outcomes as compared to RSD and (ii) ICG-PDT would produce equal efficacy among different forms of diabetes as produced in non-diabetic subjects and that diabetes mellitus would not produce negative impact on the therapeutic outcomes of ICG-PDT. Therefore, the aim of this randomized controlled clinical trial was to evaluate the efficacy of ICG-mediated aPDT in the treatment of stage III grade C periodontitis among patients with prediabetes, T2DM and non-diabetic subjects.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged ≥30 years
- •clinically diagnosed with mild to moderate periodontitis
- •self-reported type-2 DM for ≥2 years confirmed by a physician with HbA1c levels ≥6.5%
- •patients who complied with the treatment protocol.
排除标准
- •(i) pregnancy and lactation (ii) who had taken antibiotics in the previous 3 months (iii) who had undergone periodontal therapy or any decontamination treatment in their oral cavity in the previous 6 months (iv) former/current smokers (v) failure to provide a signed informed consent.
研究组 & 干预措施
Controlled Type 2 diabetes mellitus
干预措施: Indocyanine green (Drug)
Uncontrolled Type 2 diabetes melltius
干预措施: Indocyanine green (Drug)
Non-diabetic patients
干预措施: Indocyanine green (Drug)
结局指标
主要结局
Clinical attachment level
时间窗: 6 months
Clinical attachment level will be measured by adding recession with probing depth
Probing depth
时间窗: 6 months
Probing depth will be measured to the nearest millimeter from the base of the periodontal pocket to the crest of the marginal gingiva.
次要结局
- Bleeding on probing(6 months)
- Porphyromonas gingivalis(6 months)
- Interleukin-6(6 months)
- Plaque scores(6 months)
研究者
Mohammed Mahmoud Al-Momani
Professor
King Saud University