“Comparative Clinical and Radiographic Evaluation of the Efficacy of Bovine Derived Xenograft and Calcium Sulfate Hemihydrate (OsseomoldTM) with Autologous Injectable Platelet Rich Fibrin (i-PRF) and Bovine Derived Xenograft and Calcium Sulfate Hemihydrate (OsseomoldTM) with Normal Saline used in the Treatment Of Intrabony Defects in Chronic Periodontitis Patients –A Randomized Clinical Trialâ€
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Plaque index(P.I.)(SILNESS&LOE,1964)
研究概览
简要总结
Aims and Objective:
1.Toevaluate and compare clinically theeffect of BovineDerived Xenograft and Calcium Sulfate Hemihydrate (OsseomoldTM) withAutologous Injectable Platelet Rich Fibrin (i-PRF) and Bovine Derived Xenograft and Calcium SulfateHemihydrate (OsseomoldTM)with Normal Saline and its effect onclinical parameters like plaque index ,gingival index ,Probing pocket Depth andClinical Attachment Level.
2.To evaluate and compare Radiographically the effect of Bovine DerivedXenograft and Calcium Sulfate Hemihydrate (OsseomoldTM) withAutologous Injectable Platelet Rich Fibrin (i-PRF) and Bovine Derived Xenograft and Calcium SulfateHemihydrate (OsseomoldTM)with Normal Saline in the bone fillof Intrabony Periodontal Defects.
Methodology:
This studyis an Interventional Prospective Randomized Clinical Trial. It is asingleblinded, single-centre, Institution-based study.
Thepatients selected as per the inclusion and exclusion criteria, will be randomlyallotted by a computerized automated randomization method into 2 groups, GroupA and Group B, and treated as follow.
GroupA: Open flap debridement, followed by placement of Bovine DerivedXenograft and Calcium Sulfate Hemihydrate (OsseomoldTM) withAutologous Injectable Platelet Rich Fibrin (i-PRF) .
Group B: Open flap debridement, followed byplacement of BovineDerived Xenograft and Calcium Sulfate Hemihydrate (OsseomoldTM) with Normal Saline.
Study population:
Atotal of 40 patients for this study will be selected from outpatient departmentof Periodontics.
Sample size:
The assumption for sample size wasobtained from parent article Standard deviation (S.D.) of group 1= 0.78 S.D. for group 2= 0.88 Considering the difference in group means tobe 20%, power of the study as 80%, at 95% confidence interval, a ratio of samplesize (group1/ group 2) as 1 and with the significance level set at 5%, a samplesize of 40 was derived (i.e. 20 in each group).
Methods of measurement:
Clinicalparameters:
Thefollowing clinical parameters are to be recorded at baseline (pre-surgery), 1month post-surgery, 3 months post-surgery, and 6 months post-surgery.
-
Plaque Index (P.I.)(Tureskey-Gilmore-Glickman Modification of Quigley Hein)
-
Gingival Index (G.I.) (Loe and Silness,1963)
Thefollowing clinical parameters to be recorded at baseline (pre-surgery), 3months post- surgery, and 6 months post-surgery.
-
Probing Pocket Depth (PPD)
-
Clinical Attachment Level (CAL)
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients in the age group between 20-60 yrs.
- •patients diagnosed with Chronic Periodontitis.
- •Patients who are non smokers or do not consume tobacco in any other form.
- •Patients are in good systemic health with no contraindication to periodontal surgery.
- •Patients having pocket depths >5mm, intraosseous defects > 3mm and with radiographic evidence of vertical / angular bone loss in the affected sites.
- •Involved teeth to be vital and asymptomatic.
排除标准
- •One-walled osseous defects.
- •Patients suffering from any systemic diseases or with a compromised immune system.
- •Patients who had received any type of periodontal therapy for the past 6 months.
- •Patients taking immunosuppressant drugs like corticosteroids.
- •Patients with a known history of allergy to Doxycycline or Chlorhexidine or any other medicine used in the study.
- •Patients showing unacceptable oral hygiene compliance during / after Phase I periodontal therapy.
- •Pregnant and/or lactating mothers.
- •Patients who were smokers or had tobacco in any other form.
- •Patients on anticoagulant therapy.
- •Patients with bleeding disorders.
结局指标
主要结局
Plaque index(P.I.)(SILNESS&LOE,1964)
时间窗: Baseline | 1 month | 3 months. | 6 months.
Gingival index(G.I.)(LOE&SILNESS,1963)
时间窗: Baseline | 1 month | 3 months. | 6 months.
Probing pocket depth(PPD)
时间窗: Baseline | 1 month | 3 months. | 6 months.
Clinical attachment Level(CAL)
时间窗: Baseline | 1 month | 3 months. | 6 months.
次要结局
- Radiograph Bone fill will be evaluated using Intraoral radiographs of the surgical site(Radiographs will be taken at baseline post surgery and 6 months post surgery.)