Comparison Of Autologous Tooth Dentin Graft Versus Open Flap Debridement Alone In The Management Of Periodontal Intra bony Defects Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Changes in clinical attachment level CAL in the defect site
研究概览
简要总结
Title
Comparison of Autologous Tooth Dentin Graft Versus Open Flap Debridement Alone in the Management of Periodontal Intra Bony Defects A Randomized Controlled Trial
Background
Periodontal intra bony defects are a significant clinical challenge due to the loss of tooth supporting structures. Autologous tooth dentin grafts have shown promising regenerative potential because they are rich in hydroxyapatite and growth factors. This study aims to compare the clinical and radiographic effectiveness of autologous dentin grafts with open flap debridement alone to evaluate their additional regenerative benefits.
Study Design
Type of study is interventional
Design is randomized parallel group active controlled clinical trial
Blinding includes participant and outcome assessor blinded
Sample size is 15 subjects
Duration of study follow up to be inserted as per protocol
Participants
Inclusion criteria
Age between 18 to 60 years
Male and female participants
Diagnosed with chronic periodontitis with probing pocket depth of 6 millimeters or more
Systemically healthy individuals
Exclusion criteria
Smokers or tobacco users
Pregnant or lactating women
Patients with systemic illnesses such as uncontrolled diabetes or metabolic diseases
History of periodontal surgery within the past 6 months
Interventions
Group A test group receives autologous tooth dentin graft placed in the intrabony defect following open flap debridement
Group B control group receives open flap debridement alone
Primary Outcome Measures
Clinical parameters including reduction in probing pocket depth and gain in clinical attachment level
Secondary Outcome Measures
Radiographic bone fill assessed through intraoral radiographs
Observation of any adverse effects associated with the dentin graft
Randomization Method
Randomization method is permuted block randomization fixed
Allocation concealment is through sequentially numbered sealed opaque envelopes
Blinding includes participant and outcome assessor
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
- •1.Subjects of either sex between the age group of 18-60 years, who sign informed consent for the study.
- •2.Systemically healthy subjects 3.Subjects with Periodontitis having probing pocket depth of greater than or equal to 6mm and clinical attachment level of greater than or equal to 6mm after phase I therapy in at least one tooth.
- •4.At least one site that radiographically shows vertical bone loss greater than or equal to 4 mm 5.Subjects having minimum of one maxillary or mandibular tooth indicated for extraction [non root canal treated tooth] Non-smokers.
排除标准
- •1.Pregnant women or expected pregnancy during the study period.
- •2.Lactating women.
- •3.Presence of uncontrolled metabolic, endocrine, blood, neoplastic, or renal diseases.
- •4.History of Alcoholism or drug abuse.
- •5.Patients on any medication which is known to interfere with bone remodelling.
- •6.Any other conditions that might interfere with the analysis of the results.
结局指标
主要结局
Changes in clinical attachment level CAL in the defect site
时间窗: At Baseline , at One month , at Six month
Changes in probing depth (PD) in the defect site .
时间窗: At Baseline , at One month , at Six month
次要结局
- Radiographic Changes in the bone defect area BDA ( in mm2)(Any adverse reaction of Autologous Tooth Dentin grafts)
研究者
Bala Karthiga V
maulana azad institute of dental sciences