跳至主要内容
临床试验/CTRI/2026/02/103183
CTRI/2026/02/103183已完成2 期

Clinical And Radiographic Effectiveness Of Conventional And Microsurgical Access Flap Technique In Managing Horizontal Bony Defects In Periodontitis Patients: A Split Mouth Randomized Clinical Trial

Suchanda Saha1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2026年2月20日最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
35
试验地点
1
主要终点
The outcome variable of the study will be probing pocket depth(PPD),

研究概览

简要总结

World Workshop, 2017, defined Periodontitis as a chronic multifactorial inflammatory disease, characterized by progressive destruction of the tooth-supporting apparatus, associated with dysbiotic plaque biofilms. A WHO survey conducted in India, along with four other countries, observed a 100% prevalence of periodontal disease (including gingivitis) in adults in India. Periodontitis was found to start after age 15 and at 17 years, 10% of Indian boys had periodontitis. The most prevalent form of bone defect seen in individuals with periodontitis is horizontal bone loss which is also regarded as the least favorable for periodontal regeneration. Patients with horizontal bone abnormalities still have no practical choice except to use an access flap for pocket depth reduction. The purpose of periodontal flap surgery is to increase the visibility and accessibility of the underlying bone and root surfaces which will enable surgeons to carry out regenerative procedures and reduce disease activity. Numerous studies have shown that the improved visual acuity obtained from using an operating microscope improves field illumination with specially made microsurgical instruments enable more precise and non-traumatic manipulation of both soft and hard tissues. It enhances surgical access and prevents the needless removal of tissue, optimize defect debridement and root instrumentation, improve vascularization and increase flap mobility. It also increases the likelihood of achieving better primary wound closure. The use of traditional techniques for access flaps has drawbacks such as gingival recession, exposed root surfaces and opening of gingival embrasures which can result in the formation of black triangles and an unsightly appearance. Operating microscopes are integral to achieving the

advantages of periodontal microsurgery. These benefits including illumination, magnification and refined surgical skills collectively called the magnification triad are crucial for performing esthetic periodontal plastic surgeries to obtain exemplary and complex details in small scale. All operations performed under magnification beginning at 2.5x and employing an operating microscope or dental loupes are included in periodontal microsurgery. The goal of minimally invasive surgery which was first presented by Harrel and Rees in 1995, is to carefully treat the hard and soft tissues, leave as few scars as possible on the flap and reduce the amount of wound that remains after surgery. The use of smaller more accurate surgical procedures made possible by using magnification instruments like operating microscopes as well as microsurgical instruments and materials is referred as "minimally

invasive surgery". Operating microscope usage in periodontal regenerative surgery was suggested by Cortellini and Tonetti who noted improved initial wound closure potential from an average of 70% of cases acquired with regular surgery to an exceptional 92% attained with microsurgery. This study is intended to assess and compare the clinical and radiographic efficacy of conventional and microsurgical access flap for the treatment of horizontal bone defects in patients with periodontitis taking into account the findings of the previously stated literature. The null hypothesis is that no significant difference exists between the conventional and microsurgical access flap technique in

managing horizontal bony defect in periodontitis patients.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Outcome Assessor Blinded

入排标准

年龄范围
31.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Interdental CAL detectable at more than or equal to 2 non-adjacent teeth, Buccal or oral CAL more than or equal to 3 mm with pocketing more than 3 mm detectable at more than or equal to 2 teeth, Presence of bleeding on probing, Radiographic evidence of horizontal bone loss in the contralateral quadrants associated, Systemically healthy patient, Patients who are willing to undergo the treatment and agreed to give informed consent, Prior to surgical therapy, patients who will demonstrate acceptable oral hygiene Vital teeth free from dental caries.

排除标准

  • Patient who have experienced severe periodontitis in the past Furcation and vertical bone abnormalities necessitating periodontal regeneration A history of known systemic illnesses such as cancer, immunosuppressive therapy, radiation therapy, diabetes, hypertension, HIV, bone metabolic abnormalities and blood disorders Individuals whose blood pattern is aberrant Patients who take drugs that have been shown to have an impact on periodontal therapy results Individuals who had received periodontal therapy during the six months prior Mothers who are nursing or pregnant.
  • Smokers Tobacco use in any form.
  • History of periodontal surgery in the preceding 6 months which can interfere with healing.
  • The surgical areas exhibiting gingival recession.
  • Dental mobility at surgery locations.

结局指标

主要结局

The outcome variable of the study will be probing pocket depth(PPD),

时间窗: Baseline, three month and six months

次要结局

  • The outcome variable of the study will be change in plaque index (PI), gingival index (GI), relative attachment level (RAL), relative gingival margin level (RGML),(wound healing index (WHI)16 and patient’s pain perception (VAS)17 from baseline to 3 and 6 months)

研究者

发起方
Suchanda Saha
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Suchanda Saha

S.C.B Dental College and Hospital, Cuttack , Orissa, India

研究点 (1)

Loading locations...

相似试验