"Role of Guided Tissue Regeneration on Healing Outcome & Quality of Life in Combined Endo Perio Lesions With Communication: A Randomized Controlled Trial"
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Periapical healing assessment
研究概览
简要总结
The recovery of periapical defects linked to periodontal communication frequently yields less satisfactory results. Numerous studies and case reports have highlighted the notable success achieved through the application of guided tissue regeneration techniques. More recently, autologous platelet concentrate plug & placental membrane have emerged as a treatment option for addressing such lesions. Nevertheless, there has been no study using PRF-Medium with ACM membrane on the healing of aforesaid lesion & quality of life assessment.
详细描述
RESEARCH QUESTION (PICO) Does the combined application of PRF-Medium plug and ACM membrane lead to superior healing outcomes compared to conventional technique in treating apico-marginal defects with interproximal involvement? AIM &OBJECTIVES: - AIM To assess whether the combined application of PRF-Medium and ACM membrane leads to improved healing outcomes and enhanced quality of life compared to conventional techniques in patients of apico-marinal defects with interproximal involvement. PRIMARY OBJECTIVE
- To evaluate the impact of combined application of PRF-Medium and ACM membrane on healing outcomes in cases of apico-marginal defects with interproximal involvement with 2D periapical radiographs & 3D CBCT imaging. SECONDARY OBJECTIVE
- To evaluate and compare differences in quality of life of patients after periapical surgery with use of PRF-Medium and ACM membrane in cases of apico-marginal defects with interproximal involvement. PICO P(Population)- Patients with non-vital teeth and persistant chronic suppurative apical periodontitis with apico-marginal defects and interproximal involvement. I(Intervention)-Endodontic surgery followed by placement of PRF-Medium plug and ACM membrane. C(Comparison)-Endodontic surgery without using any plug and membrane. O(Outcome)- Periapical healing after surgery in both groups.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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 16yrs and above.
- •Patients with apico-marginal defects and deep pocket upto apex of tooth.
- •Failed primary root canal treatment.
- •Presence of interproximal bone loss.
- •Negative response to vitality test.
- •ASA-1 or ASA- 2 according to the classification of the American Society of Anesthesiologists)
- •Exclusion criteria:
- •Presence of vertical root fracture
- •Presence of root perforations
- •ASA-3 or ASA-4 according to the classification of the American Society of Anesthesiologists)
- •Presence of root resorption
- •Combined endodontic-periodontic lesions.
排除标准
- 未提供
结局指标
主要结局
Periapical healing assessment
时间窗: Base line to 12 months
Periapical healing comparison in 2 groups 2D radiographic healing by Rud et al and Molven et al criteria and 3D healing by modified PENN 3D Criteria. Healing will be categorised into complete, incomplete, uncertain, unsaisfactory.
次要结局
- Quality of life assessment(Base line to 12 months)