Clinical and Radiographic Evaluation of Intra Bony Defects Following Complete Versus Incomplete Removal of Granulation Tissue in Modified Minimally Invasive Surgical Technique (M-MIST). A Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 3
- 主要终点
- changes in clinical attachment level
研究概览
简要总结
This study is aiming to compare the clinical and radiographic outcomes after complete versus incomplete removal of granulation tissue during modified minimally invasive surgical technique for management of periodontal intrabony defects in patients with chronic periodontitis.
详细描述
Periodontal surgery has been expanding in the world of dentistry throughout the past years, as new techniques are emerging to treat the different and complex periodontal disorders. Surgical procedures in dentistry have undergone major changes to minimize invasiveness. In addition, novel instruments and materials have been made to suit the evolution of the surgical procedures (Cortellini. 2012).
Teeth with deep pockets associated with deep intra-bony defects are a clinical challenge for periodontists, where periodontal regeneration has been proven to be effective in managing the treatment of one-, two-, and three-wall intra-bony defects (Needleman and Tucker 2012;Needleman. 2015).
Harrel and Rees (1995) were the first to introduce the term minimally invasive surgery (MIS). MIS is used to describe the use of smaller and more precise surgical procedures that are possible by using of magnifying instruments, such as operating microscopes and microsurgical instruments and materials (Cortellini. 2012).
The rationale for the development of minimally invasive surgical technique (MIST) includes: reduction of trauma during the surgery, increase in flap and wound stability, improvement of wound primary closure, reduction of surgical time, and minimization of intra-operative and post-operative patient discomfort (Cortellini. 2007).
With the use of MIST, Cortellini and Tonneti (2009) confirmed blood clot protection with the aspects of wound and blood clot stability and primary wound closure.
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
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- systemically healthy patients
- •Age range from 25 -
- •Patients with moderate to advanced chronic periodontitis with pockets ≥ 5 mm 6-8 weeks after phase I (non-surgical) therapy.
- •Vertical 2 or 3 walls Intra-bony defects.
- •Perform and maintain good oral hygiene.
- •Able to come for the follow up appointment's needed
排除标准
- •- Smokers.
- •Pregnant patients.
- •patients with poor oral hygiene.
- •Multirooted teeth with furcation involvement.
研究组 & 干预措施
M-MIST (group A)
M-MIST(incomplete granulation tissue removal)
干预措施: M-MIST (Procedure)
M-MIST (group B)
conventional M-MIST.
干预措施: M-MIST (Procedure)
结局指标
主要结局
changes in clinical attachment level
时间窗: at baseline then 6, 9 and 12 months
It is the distance from the cement-enamel junction to the depth of the pocket.
次要结局
- patient satisfaction(12 months post-surgery)
- amount of bone fill(at baseline then at 6, 9 and 12 months)
- patient pain and discomfort(at day of the surgery then at 1 , 3 and 7 days post-surgery)
- changes in pocket probing depth(at baseline then at 6, 9 and 12 months)
- changes in gingival recession(at baseline then at 6, 9 and 12 months)
研究者
Ahmed Ibrahim
principle investigator
Cairo University