To Evaluate the Efficacy of Guided Tissue Regeneration in the Healing of Periapical Defects With Periodontal Communication :A Randomized Controlled Trial With 3D Analysis Using CBCT."
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- healing of periapical defects with periodontal communication with or without the use of guided tissue regeneration technique
研究概览
简要总结
Healing of the Apicomarginal defects will be checked by comparing 2 groups . In first group amniotic membrane will be applied over the defect before flap closure during surgery and in second group no GTR material will be applied. Healing of the lesions will also be compared 2 dimensionaly and 3 dimensionaly using CBCT
详细描述
Study Title: - To evaluate the efficacy of guided tissue regeneration in the healing of periapical defects with periodontal communication: A randomized controlled trial with 3D analysis using CBCT.
Rationale: - Healing of lesions with apicomarginal defects is often less satisfactory. Various studies and case reports have reported high success rate with the use of guided tissue regeneration technique. Only few clinical trials have evaluated the effect of guided tissue regeneration on the healing of apicomarginal defects. To best of our knowledge only two studies have conducted randomized controlled trial. However, no study has used CBCT for the assessment of healing in such type of lesions. So, this is the first randomized controlled trial studying the effect of guided tissue regeneration in the healing of periapical defects with periodontal communication using 3D radiological evaluation using CBCT.
Aim & Objectives: - 1. To evaluate the difference in the healing outcome of periapical defects with periodontal communication with or without the use of guided tissue regeneration technique 2. To evaluate the difference in the healing outcome derived from the assessment of 2D periapical radiographs and 3 D CBCT imaging.
Setting: - Study will be conducted in Post Graduate Institute of Dental Sciences, Rohtak in the department of Conservative Dentistry & Endodontics.
Study Design: - A randomized controlled trial Time Frame: - 12 to 18 months Population / Participants: - Patients of age 16 years (male/female) and above will be enrolled in the study.
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, Outcomes Assessor)
盲法说明
double
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.
- •Patients with no general medical contraindications for oral surgical procedures (ASA-I and ASA-II according to the classification of the American Society of Anesthesiologist's.
- •periapical defect with periodontal communication.
- •Periodontal pocket >6mm with apicomarginal communication confined to buccal aspect of interproximal space or mid buccal aspect of the root.
- •Negative response to vitality test.
- •failed previous root canal treatment with purulent discharge or failed previous surgery or recurrent episode of purulent discharge.
排除标准
- •Presence of buccal bone on flap elevation.
- •Unrestorable tooth.
- •fractured /perforated roots.
- •pregnant females and lactating mothers
研究组 & 干预措施
periapical surgery with amniotic membrane
periapical surgery will be done and amniotic membrane will be placed over the defect before closure of flap
干预措施: Periapical surgery with amniotic membrane (Procedure)
periapical surgery without amniotic membrane
periapical surgery will be done without the placement of amniotic membrane over the defect before closure of flap
干预措施: periapical surgery without amniotic membrane (Procedure)
结局指标
主要结局
healing of periapical defects with periodontal communication with or without the use of guided tissue regeneration technique
时间窗: BASE LINE TO 1YEAR
Follow up of patients will be carried out at 3, 6, 9 \& 12 months and outcome measures will be assessed clinically by absence of signs and symptoms and 2 dimensionally using radiographs by Rud and Molven criteria for periapical healing and 3 dimensionaly using CBCT by modified PENN criteria at 12 months follow up for periapical healing and buccal bone level.
次要结局
- the difference in the healing outcome as observed derived from the assessment of 2D periapical radiographs and 3 D CBCT imaging.(BASE LINE TO 1 YEAR)