Comparative evaluation of 5 percent Melatonin gel in combination with Platelet rich Fibrin and Platelet Rich Fibrin alone in the treatment of Intrabony defects: A Clinico-Radiographic Study.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 21
- 试验地点
- 1
- 主要终点
- Bone fill
研究概览
简要总结
Comparative evaluation of 5% Melatonin gel in combination with Platelet rich Fibrin and Platelet Rich Fibrin alone in the treatment of Intrabony defects: A Clinico-Radiographic Study.
Periodontitis is a chronic as well as multifactorial disease and if it left untreated then there are higher chances of destruction of periodontal apparatus which include, cementum, periodontal ligament and alveolar bone as a sequel of subgingival plaque accumulation which leads to inflammatory condition, caused by microbial infection and unbalanced host immune responses.
Melatonin has been reported to promote osteoblastic differentiation and formation of a bone. Melatonin accelerates the synthesis of type I collagen fibers in human osteoblasts. It also improves the gene expression of bone sialoprotein, alkaline phosphatase, osteopontin, and osteocalcin in preosteoblasts.
Choukroun et al described that platelet-rich fibrin (PRF), is a second-generation platelet concentrate incorporates platelets and growth factors within fibrin membranes.
Previously very few evaluations were studied to detect 5% Melatonin gel in combination of PRF and PRF alone in the treatments of intrabony defects by Cone Beam Computed Tomography (CBCT). So this study is designed to evaluate and compare the efficacy of 5% Melatonin gel in combination with PRF and PRF alone in the amount of bone fill obtaining as a treatment modality in intrabony defects in Periodontitis by CBCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients with stage III periodontitis assessed by probing pocket depth (PPD) ≥ 6mm, interdental clinical attachment loss (CAL) ≥ 5mm.
- •Patients with intrabony defects in either maxillary or mandibular arch.
排除标准
- •Patients with history of systemic diseases, allergies or drug usage.
- •Patients who have undergone periodontal treatment in previous 6 months.
- •Pregnant or lactating women.
- •Smokers, tobacco chewers and patients with poor oral hygiene index will be excluded from the study.
- •In addition, tooth with caries, mobility greater than grade II will be excluded.
结局指标
主要结局
Bone fill
时间窗: Baseline, 3 and 6 months.
次要结局
- 1) To assess Clinical attachment loss (CAL), probing pocket depth (PPD) in intrabony defects when treated with 5% Melatonin gel in a combination with PRF at baseline, 3 months and 6 months postoperatively.(2) To assess Clinical attachment loss (CAL), probing pocket depth (PPD) in intrabony defects when treated with PRF alone at baseline, 3 months and 6 months postoperatively.)
研究者
Dr. Surekha Rathod
Ranjeet Deshmukh Dental College and Research Centre, Nagpur.
