Effects of Guided Tissue Regeneration on the Healing of Through & Through Periradicular Lesions: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 主要终点
- Change in periapical radiolucency by radiograph 1. Complete healing, 2. Incomplete healing 3. Uncertain healing 4. Unsatisfactory healing
研究概览
简要总结
Study Title: Effects of Guided Tissue Regeneration on the Healing of Through & Through Periradicular Lesions - A Randomized Controlled Study
Rationale: Through and through defects found to be difficult to heal without GTR intervention. Various studies has been done either with graft or without graft but no randomized controlled trial has been done on resorbable membrane(GTR) in through and through lesion.
Aim & Objectives: To evaluate the effect of resorbable collagen membrane in the healing of through & through lesion.
Setting: Study was conducted in Post Graduate Institute Of Dental Sciences, Rohtak in the department of Conservative Dentistry & Endodontics.
Study Design: Randomized Controlled Trial
Time Frame: March 2016 to October 2017
Population / Participants: Patients of age 16 years (male/female) and above were enrolled in the study.
Inclusion Criteria: Patients of age 16 years and above, -ve response to vitality test, failed previous root canal treatment with purulent discharge, failed previous surgery, 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: 30 patients (15 patients in each group)
Methods: Clinically and radiographically diagnosis of lesion, vitality check by 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: Follow up of patients were carried out at 3, 6, 9 & 12 months and outcome measures were compared with same method done pre operatively and described as Complete healing, incomplete healing (scar tissue), uncertain healing, unsatisfactory healing (failure).
Statistical method: Data will be analyzed with suitable statistics method.
详细描述
The research process was 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 were be included in the study.
INCLUSION CRIETERIA :-
- Patients of age 16 years and above with a clinical & radiographic diagnosis of through and through periradicular lesion.
- Negative response to vitality test with radiographic evidence of periapical rediolucencies.
- Failed previous root canal treatment with purulent discharge and radiographic evidence of periapical pathology.
- Failed previous surgery with persistent bony lesion.
- Recurrent episode of purulent discharge and adequate final restoration with no clinical evidence of coronal leakage.
EXCLUSION CRIETERIA :-
- 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
- The need for antibiotic prophylaxis prior to dental care
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)
盲法说明
Both the participant and primary investigator are blinded in the study until whole surgical procedure is completed and before suturing the flap.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients of age 16 years and above with a clinical & radiographic diagnosis of through and through periradicular lesion.
- •Negative response to vitality test with radiographic evidence of periapical rediolucencies.
- •Failed previous root canal treatment with purulent discharge and radiographic evidence of periapical pathology.
- •Failed previous surgery with persistent bony lesion.
- •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
- •The need for antibiotic prophylaxis prior to dental care
结局指标
主要结局
Change in periapical radiolucency by radiograph 1. Complete healing, 2. Incomplete healing 3. Uncertain healing 4. Unsatisfactory healing
时间窗: Baseline to 1 year
Healing of the lesion will be checked at 3 months interval up to 1 year with the help of software CDR DICOM. At the end of 1 year this reduction in the pathology of lesion will be categorized as complete, incomplete, uncertain, unsatisfactory. Clinical and radiographic examinations will be performed every 3, 6 and 12 months by assessing the same parameters as baseline except that PD, CAL, and GMP will not measured until 12 months. Radiographic evaluations Jig radiographs will be taken at 3, 6 and 12th month of follow up.
次要结局
- Probing depth(Baseline to 1 year)
- Clinical attachment level(Baseline to 1 year)