To Evaluate the Efficacy of Platelet Rich Plasma(PRP) in the Healing of Through and Through Periapical Lesions.
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- CHANGE IN PERIAPICAL RADIOLUCENCY ON RADIOGRAPH
研究概览
简要总结
Title : Evaluation of the efficacy of Platelet Rich Plasma (PRP) in healing of through and through lesions
Rationale: Bone replacement analogues have been used in the healing after periapical surgery. It has been a controversial issue to use bone grafts due to varied outcomes of different studies showing both improved outcomes and no difference. Lacunae while using bone grafts is their radiopacity which compounds the radiographic incomplete or uncertain healing. Thence we will be using platelet rich plasma as bone filling material.
Aims and Objectives : To evaluate outcome of platelet rich plasma in healing after periapical surgery for through an through lesions.
Setting: Department of Conservative Dentistry and Endodontics, PGIDS, Rohtak, Haryana.
Study Design: Randomized controlled trial
Time frame: 12-18 months
Population/participant : Patients of age 16-45 years (male/female) will be enrolled in the study with diagnosis of through and through lesions.
Inclusion criteria:- Patients of age 16 -45 years, -ve response to sensibility test, failed previous rct with purulent discharge, recurrent episode of purulent discharge.
Exclusion Criteria:- Unrestorable tooth, fractured /perforated roots, serious medical illness, smokers, pregnant females and lactating mothers, grade 3 mobile teeth, the need for antibiotic prophylaxis prior to dental care.
Sample size - a sample size of 30 patients has been calculated with n=15 in each group.
Methods- Clinically and radiographically diagnosis of lesion, sensibility test by heat, cold, EPT, preoperative evaluation by bleeding on probing, clinical attachment level, gingival marginal position & pocket depth. Surgical procedures will be carried out under operating microscope with 8 × 16 magnification by following standardized treatment methods.
Outcome Measures- The primary outcome variables observed for the study will be 3,6,9,12 months clinical and radiographic success rates in terms of resolution of periapical radiolucency using the same criteria as preoperatively on the radiograph and alleviation of clinical sign and symptoms.
Statistical Analysis : Intergroup and intra group comparison will be done according to distribution of data. Categorical data will be analyzed using chi-square test. Regression analysis will be done to observe any association between dependent and independent variables.
详细描述
The research process will be carried out in the Department Of Conservative Dentistry and Endodontics, Post Graduate Institute of Dental Sciences, Rohtak. Patients with through and through periradicular lesions diagnosed radiographically and clinically will be included in the study.
INCLUSION CRITERIA :-
- Patients of age 16-45 years with a clinical & radiographic diagnosis of through and through periradicular lesion through CBCT.
- Negative response to sensibility tests with radiographic evidence of periapical radiolucencies.
- Failed previous root canal treatment with purulent discharge and radiographic evidence of periapical pathology.
- Recurrent episode of purulent discharge and adequate final restoration with no clinical evidence of coronal leakage.
EXCLUSION CRITERIA :-
- Unrestorable tooth
- Fractured /perforated roots
- Serious medical illness (uncontrolled/poorly controlled diabetes, unstable or life Threatening conditions or requiring antibiotic prophylaxis)
- Smokers
- Pregnant females and lactating mothers
- Grade 3 mobile teeth
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients of age 16-45 years with a clinical & radiographic diagnosis of through and through periradicular lesion through CBCT.
- •Negative response to sensibility tests with radiographic evidence of periapical radiolucencies.
- •Failed previous root canal treatment with purulent discharge and radiographic evidence of periapical pathology.
- •Recurrent episode of purulent discharge and adequate final restoration with no clinical evidence of coronal leakage.
排除标准
- •Unrestorable tooth
- •Fractured /perforated roots
- •Serious medical illness (uncontrolled/poorly controlled diabetes, unstable or life Threatening conditions or requiring antibiotic prophylaxis)
- •Pregnant females and lactating mothers
- •Grade 3 mobile teeth
研究组 & 干预措施
Periapical surgery without PRP
MTA Retrograde filling will be performed after apicectomy for involved teeth and flap will be closed without placement of PRP
干预措施: periapical surgery without PRP (Procedure)
Periapical surgery with PRP
MTA Retrograde filling will be performed after apicectomy for involved teeth and PRP will be filled in the lesion before closure of flap
干预措施: PRP (Procedure)
结局指标
主要结局
CHANGE IN PERIAPICAL RADIOLUCENCY ON RADIOGRAPH
时间窗: Baseline to 1 year
Radiographs will be taken at an interval of every 3 months for 1 year with the help of CDR DICOM. The lesion will be categorised as complete healing,incomplete healing,uncertain healing and failure. cllinical and radiographic examination will be performed at 3,6,9 and 12 months on same parameters as baseline except PD,CAL and GMP will not be measured till 12 months
次要结局
- Clinical attachment level(Baseline to 1 year)
- Probing depth(Baseline to 1 year)