A clinical and radiographic study to evaluate and compare the effectiveness of Nanocrystalline hydroxyapatite with Advanced Platelet Rich Fibrin(A-PRF)and Hydroxyapatite reinforced Beta tri-calcium phosphate(HA+β-TCP) with A-PRF in the treatment of human infrabony defects-A cross sectional study.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Radiographic Bone Fill In Infrabony Defects at 6 Month Post Surgery.
研究概览
简要总结
Aim of my study is to evaluate and compare the effectiveness of Nanocrystalline hydroxyapatite with Advanced platelet rich fibrin(A-PRF) and Hydroxyapatite reinforced Beta tri-calcium phosphate in Human infrabony defects.
Objectives
1) To evaluate the effectiveness of Nanocrystalline hydroxyapatite in combination with A-PRF in terms of gain in clinical attachment level(CAL), reduction in probing pocket depth (PPD) and radiographic bone fill in infrabony defects at 6 months post surgery.
2) To evaluate the effectiveness of Hydroxyapatite reinforced Beta-tricalcuim phosphate in combination with A- PRF in terms of gain in clinical attachment level , reduction in probing depth , and radiographic bone fill at 6 month post surgery.
3) To compare the effectiveness of Nanocrystalline hydroxyapatite with A-PRF and Hydroxyapatite reinforced Beta–tricalcuim phosphate with A- PRF at 6 month post surgery clinically and radiographically.
In the study total of 28 healthy patients, with moderate to advanced chronic periodontitis based on clinical and radiographic confirmation of angular bony defects will be chosen from the outpatient Department of Periodontics. Clinical measurements recorded will be plaque index , Papillary bleeding index ,Probing Pocket depth, Relative attachment level , and Relative gingival marginal level . All the clinical measurements will be recorded on the day of surgery and 6 month post surgery .
Test group will consist of Nanocrystalline hydroxyapatite with Advanced platelet rich fibrin (A-PRF) and control group will consist of Hydroxyapatite reinforced Beta tricalcuim phosphate with A-PRF .The mean and standard deviation values will be calculated for plaque index and papillary bleeding index and also for all clinical parameters including RGML ,RAL,PPD,WKG and GR. Student’s paired t- test will be used to correlate the data from baseline up to 6 months for each treatment group . Student’s unpaired t test will be used for comparisions between treatment groups at baseline level and 6 months.
Summary :
1. At six month post-surgery both treatment modalities demonstrated statistically significant improvements with regards to CAL gains, PPD reduction and reduction in radiographic defect depth.
2. Greater PPD reduction, CAL gain and reduction in radiographic defect depth was found in Nanocrystalline hydroxyapatite with A-PRF group than HA+β-TCP in combination with A-PRF group at six months after surgery but the difference was statistically non-significant when compared between both the groups.
3. Grafting with Nanocrystalline hydroxyapatite along with A-PRF group resulted in higher radiographic defect fill compared to HA+β-TCP in combination with A-PRF group and the difference was statistically significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
入排标准
- 年龄范围
- 20.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Systematically healthy patient.
- •2.Following initial therapy, presence of minimum 1 or 2 interproximal infrabony osseous defect PPD ≥ 5mm and CAL ≥ 5 and which are radiographically noticeable.
- •3.Clinically and radiographically there should be ≥ 3mm defect depth which is affirmed on intrasurgical measurement.
- •4.A radiographically determined defect base should be minimum of 3 mm above the apex of the tooth 5.Presence of minimum ≥2mm zone of keratinized gingiva to permit total soft tissue coverage of the defect area.
排除标准
- •1.Patient diagnosed with aggressive periodontitis.
- •2.Patients with poor oral hygiene care (Plaque Index >1) 3.Patients using tobacco in any form .
- •4.Involved tooth with inadequate root canal therapy and subsequent restoration 5.Involved tooth having mobility greater than grade II ,or defect extending in to furcation and third molars .
- •6.Prior history of periodontal surgery of the selected segment.
- •7.Females who are pregnant or lactating.
- •8.There is clinical and radiographic sign of untreated acute infection at the selected site, root fracture,apical pathology ,severe root irregularities, cemental pearls, cementoenamel projections, untreated carious lesion on root surface.
结局指标
主要结局
Radiographic Bone Fill In Infrabony Defects at 6 Month Post Surgery.
时间窗: Radiographic Bone Fill In Infrabony Defects at 6 Month Post Surgery.
次要结局
- Gain in Clinical Attachment Level( CAL)(Reduction In Probing Pocket Depth (PPD))