Comparative Evaluation of the Effects of Riboflavin Photodynamic Therapy as an Adjunct to Ultrasonic Scaling on Periodontal Health in Orthodontic Patients: A Split-Mouth Randomized Controlled Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Gingival Index
研究概览
简要总结
Riboflavin can be used as a photosensitizer agent for antimicrobial photodynamic therapy in the field of orthodontics. There are no clinical studies regarding this subject at present. To overcome these lacunae in the literature, a prospective split-mouth randomized controlled trial will be designed to evaluate the effect of riboflavin photodynamic therapy on periodontal health. Patients undergoing fixed orthodontic treatment will be selected as per eligibility criteria from the Department of Orthodontics and Dentofacial Orthopedics. Ultrasonic scaling will be performed in both the experimental and control groups, followed by riboflavin photodynamic therapy irradiation only in the experimental group at the first visit (T0), and subsequently after 1 month (T1), 2 months (T2), 3 months (T3), 4 months (T4), and 5 months (T5) after ultrasonic scaling. The Plaque Index, Gingival Index, Bleeding on Probing, and Pocket Depth will be measured at the first visit (T0), after 1 month (T1), 3 months (T3), and 6 months (T6) before receiving photodynamic therapy and compared in both groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 30.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who can follow specific brushing techniques as instructed by the researcher.
- •Patients undergoing fixed orthodontic treatment from at least 6 months.
- •Patients with Gingival index greater than or equal to 1.1, Plaque index greater than or equal to 1 and Bleeding on probing greater than or equal to
- •Patients without oral lesions.
- •Patients who are willing to sign informed consent (self/parent/guardian).
排除标准
- •Individuals with special needs.
- •Patient with adverse oral habits such as smoking, tobacco chewing, nail biting.
- •Patients with systemic conditions like diabetes, immune system disorders, glucose-6-phosphate dehydrogenase deficiency or under drugs like anti-depressants- monoamine oxidase inhibitors (MAOIs), antiseptic mouthwash, corticosteroid or immunosuppressant drugs which affects the gingiva.
- •Patients with history of previous periodontal treatment, antibiotic or anti-inflammatory therapy received in the 3 months immediately prior to treatment or during treatment.
- •Pregnant or lactating women.
结局指标
主要结局
1. Gingival Index
时间窗: At first visit (T0), after 1 month (T1), 3 months (T3) and 6 months (T6).
2. Plaque Index
时间窗: At first visit (T0), after 1 month (T1), 3 months (T3) and 6 months (T6).
3. Pocket Depth
时间窗: At first visit (T0), after 1 month (T1), 3 months (T3) and 6 months (T6).
4. Bleeding on Probing
时间窗: At first visit (T0), after 1 month (T1), 3 months (T3) and 6 months (T6).
次要结局
- 1. Pain and Discomfort(2. Adverse Effects or Complications)
研究者
Dr Javed Sodawala
Chhattisgarh Dental College and Research Institute