Comparison of Injectable Biocomposites AND Hydroxyapatite Bone Cement in the Treatment Of Periodontal Intrabony Defects
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The outcome expected will be to compare the
研究概览
简要总结
Periodontitis is an inflammatory disease of the periodontium which elicits an immune response resulting in the loss of supporting structures of the teeth. The bone loss which is induced by periodontitis i.e. osseous defects occur either single or in different combination forms. Intrabony osseous defect is defined as a “periodontal defect within the bone surrounded by one, two or three bony walls or a combinationâ€. Treatment with grafting modalities, xenogenic or alloplastic osteoconductive materials, such as bovine bone-derived mineral, coralline calcium carbonate, calcium-layered composite of poly-methyl-methacrylate and poly-hydroxyl-ethyl-methacrylate, hydroxyapatite, bioactive glass and tricalcium phosphate are options. Bone graft is use to fill the defect, supporting and promoting new bone formation, through its use as mechanical scaffold and provides a structure for new cells to form new bone growth in the healing process. Hydroxyapatite cement (HAC) has been extensively studied as the bone grafting material in periodontal regeneration. The biocompatibility, osteoconductive nature and resorptive properties of HAC suggest it has potential to function as a successful bone substitute material. biocomposites(BC) such as beta tricalcium phosphate and calcium sulfate represent a unique bi-phasic composition with a negative charged surface. This property stimulates bone cell activity by harnessing key proteins, osteoblast adhesion and proliferation.In this study thirty patients diagnosed with periodontitis showing pocket depth >5mm and radiographic evidence of vertical/ angular bony defects will be selected from Department of Periodontology, SPPGIDMS, Lucknow and will be allocated randomly into two groups. Groups A (biocomposites + open flap debridement) and Group B (hydroxyapatite cement + open flap debridement). Clinical periodontal parameters like probing pocket depths (PPD), clinical attachment level (CAL), plaque index (PI), gingival index (GI), and radiographic assessment of the defect will be evaluated at baseline, 3 and 6 months after treatment.The present study will evaluate and compare the efficacy of injectable biocomposites and HAC in periodontal regeneration. We anticipate that this will enable improved treatment of periodontal osseous defects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 16.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient age between16-40 years diagnosed with periodontitis 2.Teeth selection All the teeth diagnosed with periodontal osseous intrabony defect Two or three wall defect on clinical and radiographic evaluation 3.PD more than or equal to 4 mm and an intrabony component more than or equal to 3 mm 4.The depth of the intraosseous component of the defect was evaluated clinically and radiographically during the screening phase but it had to be confirmed during surgery 5.Systemically healthy patients 6.Patients with established willingness and ability to perform adequate oral hygiene.
排除标准
- •Heavy smoking (more than 10 cigarettes)
- •Presence of underlying medical conditions such as immunosuppression or diabetes pregnancy and medically compromised conditions that would put the patient at risk for periodontal surgery.
结局指标
主要结局
The outcome expected will be to compare the
时间窗: Baseline | 3 months | 6 months
regenerative capacity of injectable biocomposites & granular form of Hydroxyapatites in
时间窗: Baseline | 3 months | 6 months
an adjunct with OFD in treatment of intrabony defects.
时间窗: Baseline | 3 months | 6 months
次要结局
- the secondary outcome is radiographic evaluation of the bone fill & bone density post operative in treatments of intrabony defects.(6 months post operative)