Clinical and Radiographic Evaluation of Melatonin and Metformin Loaded Nanoparticles in the Treatment of Periodontal Intra-bony Defects: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 发起方
- Amira ragab
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Radiographic assessment
研究概览
简要总结
The goal of this clinical trial is to assess the effectiveness of local delivery of melatonin and metformin loaded nanoparticle gel as adjunct to scaling and root planning (SRP) in the treatment of periodontal intra bony defect.
fifty two healthy patients(n=52) with at least one periodontal intra-bony defect will be included in the study, all selected patients will be motivated about the benefit of plaque control and periodontal treatment . The participant will be selected from outpatient clinic of the Department of Oral Medicine and Periodontology , Faculty of dentistry, Mansoura University . The participant will be classified into four groups :group I and II are test groups but group III and IV are control groups .Patients in group I will be treated with melatonin loaded nanoparticle gel while in group II will be treated with melatonin and metformin loaded nanoparticles which will be applied weekly for four weeks after SRP had been completed and group III will be treated with placebo gel while group IV will be treated with only scaling and root planning.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
triple blinded study
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients with at least one intra-bony defect diagnosed clinically and radiographically
排除标准
- •Patients with systemic diseases.
- •Pregnant and lactating females.
- •Smokers and tobacco chewers.
- •History of antibiotic and periodontal therapy in the last 3 months.
- •Patients not compliant with oral hygiene procedures.
- •Patients with a known or suspected allergy to the melatonin or metformin.
- •Individuals on systemic drug affecting metabolic bone diseases and medically compromised patients.
研究组 & 干预措施
melatonin loaded nanoparticle (test group)
13 patients will be treated with melatonin loaded nanoparticle gel as adjunct to scaling and root planning .it will be applied once weekly for four weeks.
干预措施: Melatonin gel (Drug)
melatonin loaded nanoparticle (test group)
13 patients will be treated with melatonin loaded nanoparticle gel as adjunct to scaling and root planning .it will be applied once weekly for four weeks.
干预措施: scaling and root planning (Procedure)
melatonin and metformin loaded nanoparticle (test group)
13 patients will be treated with melatonin and metformin loaded nanoparticle gel as adjunct to scaling and root planning .It will be applied once weekly for four weeks.
干预措施: Metformin and melatonin gel (Drug)
melatonin and metformin loaded nanoparticle (test group)
13 patients will be treated with melatonin and metformin loaded nanoparticle gel as adjunct to scaling and root planning .It will be applied once weekly for four weeks.
干预措施: scaling and root planning (Procedure)
placebo gel (control group)
13 patients will be treated with placebo gel as adjunct to scaling and root planning .It will be applied once weekly for four weeks.
干预措施: placebo gel (Drug)
placebo gel (control group)
13 patients will be treated with placebo gel as adjunct to scaling and root planning .It will be applied once weekly for four weeks.
干预措施: scaling and root planning (Procedure)
no gel (control group)
13 patients will be treated with only scaling and root planning ..
干预措施: scaling and root planning (Procedure)
结局指标
主要结局
Radiographic assessment
时间窗: all the parameter will be evaluated after 6 months
all the radiographic parameters will be measured on cone beam computed radiography (CBCT) .The depth of intra bony defect will be measured from cemento enamel junction(CEJ) to base of the defect (BD).The Height of the defect from CEJ to the crest of bone adjacent to the defect and the width of the defect will be from highest point of alveolar crest to dental root adjacent to defect .
次要结局
- plaque index according to Silness P.Loe H 1964(6 months)
研究者
Amira ragab
BDS, clinical demonstrator, Oral Medicine, Periodontology, Diagnosis and Oral Radiology Department
Mansoura University