Comparative clinical and radiographic evaluation of Minimally invasive non-surgical and Minimally invasive surgical therapy in treatment of periodontal intra-bony defect: A randomized clinical trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- clinical parameters (probing pocket depth and clinical attachment level), radiographic parameters (defect depth and defect width) in periodontal intrabony defects treated with minimally invasive non-surgical and minimally invasive surgical therapy.
研究概览
简要总结
Periodontitis is a chronic, multifactorial inflammatory disease caused by dysbiotic plaque biofilms. It leads to the progressive destruction of the supporting structures of teeth, including connective tissue and alveolar bone. Clinical signs of periodontitis include clinical attachment loss (CAL), radiographic bone loss, periodontal pocket formation, and gingival bleeding. In 2010, severe periodontitis was ranked as the sixth most prevalent disease globally, affecting about 11.2% of the population. As the disease progresses, it alters the morphology of the alveolar bone, leading to both horizontal and vertical bone defects. Vertical defects, also known as intrabony defects, are of particular concern due to their association with disease progression and increased risk of tooth loss. These defects form in an oblique pattern with the base of the defect located apically, forming a trough-like hollow adjacent to the root surface.
Intrabony defects pose a challenge in periodontal treatment due to limited accessibility.
While non-surgical interventions such as scaling and root planing can help in re-establishing the gingival contour, they often fail to resolve the underlying bone defects. This limitation can lead to persistent deep pockets and irregular bone healing, necessitating more advanced interventions. Traditionally, osseous surgical procedures have been employed to correct bony architecture. These include osteoplasty, which reshapes marginal bone, and ostectomy, which removes supporting bone. Although effective, these techniques often involve the sacrifice of tooth-supporting structures and result in gingival recession, which can be aesthetically unacceptable.
As a response to these drawbacks, periodontal therapy has evolved to adopt more conservative approaches. Instead of resective surgeries, clinicians have focused on regenerative techniques aimed at restoring lost bone and periodontal structures.
Periodontal regeneration often involves the use of bone grafts and barrier membranes. While effective, this approach can be costly, technique-sensitive, and sometimes unpredictable. To overcome these challenges, minimally invasive surgical techniques (MIST) were introduced. First described by Harrel and Rees, MIST emphasizes minimal flap reflection, reduced tissue trauma, and preservation of blood supply, thereby enhancing wound healing and reducing post-operative morbidity. Hunter and Sacker later refined the concept by introducing magnification tools such as surgical microscopes and loupes to perform delicate procedures in small areas. Building upon this concept, a minimally invasive non-surgical therapy (MINST) was introduced by Ribeiro et al. This technique maintains the principles of MIST but eliminates the need for surgical access. Ribeiro emphasized that true minimal invasiveness is not just defined by the use of magnification tools, but by the preservation of gingival architecture and careful handling of tissues. In their study, similar clinical attachment gains were reported for both surgical (2.8 mm) and non-surgical (2.6 mm) approaches, indicating comparable efficacy. Nibali et al. further developed a protocol for MINST that involves the use of micro-instruments for root debridement, magnification for precise visualization, and stabilization of the blood clot—all crucial for successful outcomes. A recent study by Jaimini Mehta et al. further supported the effectiveness of MINST, showing significant clinical improvements including reduced probing depth, gain in attachment levels, and radiographic bone fill. These findings indicate that MINST can serve not only as a pre-treatment strategy but also as a viable alternative to surgical methods.
Given the advantages of lower morbidity, reduced cost, and shorter treatment time, MINST presents an appealing approach. However, literature directly comparing MINST and MIST remains limited. Therefore, the present study aims to evaluate and compare the effectiveness of minimally invasive non-surgical therapy versus minimally invasive surgical therapy in the treatment of periodontal intrabony defects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Patient diagnosed with periodontitis stage
- •2.Probing pocket depth more than or equal to 6mm with Radiographic intrabony defect depth more than or equal to 3mm at minimum 1 site.
- •3.Intrabony Defects not associated with furcation involvement.
- •4.Patient should have 20 teeth along with adjacent teeth to the defect site.
- •5.Patient with adequate width of attached gingiva.
排除标准
- •1.Smokers (current or in past 5years), alcohol, drug abuse.
- •2.Medical history including diabetes, hepatic, renal disease, other serious medical conditions or transmittable diseases.
- •4.Systemic antibiotic therapy during the 3 months preceding the baseline exam 5.Pregnant or lactating women 6.Periodontal treatment at the study site within the last 12 months 7.Root canal treated tooth, prosthesis and class 2 restoration containing tooth at defect site and active orthodontic treatment.
- •8.Osseous lesion other than intrabony defect at defect site.
结局指标
主要结局
clinical parameters (probing pocket depth and clinical attachment level), radiographic parameters (defect depth and defect width) in periodontal intrabony defects treated with minimally invasive non-surgical and minimally invasive surgical therapy.
时间窗: Base line, 3 months, 6 months
次要结局
- Plaque index, gingival index, and gingival marginal level in treatment of periodontal intrabony defects with minimally invasive non-surgical therapy and minimally invasive surgical therapy.
- pain perception in periodontitis patients with intrabony defects treated with minimally invasive non-surgical and minimally invasive surgical therapy(1st day and 7th day post surgery.)
- correlation clinical and radiographic parameters in periodontal intrabony defects when treated with minimally invasive non-surgical and minimally invasive surgical therapy.(base line, 3 months, 6 months)
研究者
Dr Gauri Ugale
Maharashtra institute of dental sciences and research dental college Latur
