跳至主要内容
临床试验/NCT03169920
NCT03169920已完成不适用

Evaluation of the Efficacy of Autologous Platelet Rich Fibrin With Modified Minimally Invasive Surgical Technique (M-MIST) in the Treatment of Intrabony Defects: A Randomized Clinical Trial

Postgraduate Institute of Dental Sciences Rohtak2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2016年11月30日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
36
试验地点
2
主要终点
PD

研究概览

简要总结

This study evaluates the efficacy of M-MIST with or without PRF in the treatment of intrabony defects.Taking into consideration of advantages of PRF and M-MIST it was hypothesised that this combination (PRF+M-MIST) would be more beneficial in achieving healing of intrabony defects. Furthermore the concomitant use of Platelet Rich Fibrin with M-MIST has not been previously attempted in periodontal practice.

详细描述

INTRODUCTION

In the last two decades, some clinical investigators have focused their interest on the development of minimally invasive surgical approaches in periodontal surgery. Harrel & Rees proposed the minimally invasive surgery (MIS) with the aim to produce minimal wounds, minimal flap reflection and gentle hand ling of the soft and hard tissues in periodontal surgery. Cortellini & Tonetti tested the use of operative microscopes and microsurgical instruments to increase visual acuity and accuracy in the application of papilla preservation flaps in periodontal regeneration. The increased patient acceptance and decreased morbidity with minimally invasive surgery offers a promising therapeutic modality and may replace the need for more extensive surgical procedures. Recently, a new surgical approach, the ''minimally invasive surgical technique (MIST)'', has been proposed to treat isolated intrabony defects with periodontal regeneration. Results from a cohort study in isolated deep intrabony defects showed marked improvements in terms of clinical attachment level (CAL) gains and PD reduction. The background foundations for this technique are the concepts of the MIS, and the application of papilla preservation techniques with a microsurgical approach. The cited study also reported a very limited patient morbidity and a reduced length of the surgical procedure following application of the MIST. An enhancement of this technique, the modified minimally invasive surgical technique (M-MIST), has been recently designed to further reduce the surgical invasiveness, with three major objectives in mind: (1) minimize the interdental tissue tendency to collapse, (2) enhance the wound/soft tissue stability and (3) reduce patient morbidity.

Periodontal researchers and clinicians, in an effort to develop effective regenerative therapies, have sought to understand key events involved in the regeneration of the periodontium. An increased knowledge of specific cellular response and function within the periodontium has led to the development of numerous treatment modalities exhibiting different degrees of success.

Treatments including ''grafting'' with bone or bone substitutes, stimulation of cells with growth factors, hormones, or extracellular matrix proteins; cell occlusive barrier membranes for selective cell growth in periodontal defects; and modification of the tooth root surface have all been explored for their ability to predictably regenerate the periodontium. Although some treatments have yielded promising results, there remains a need for a treatment that leads to faster and more predictable regeneration of the periodontium.

The development of bioactive surgical additives, which are being used to regulate the inflammation and increase the speed of healing process, is one of the great challenges in clinical research. In this sense, healing is a complex process, which involves cellular organization, chemical signals, and the extracellular matrix for tissue repair. The understanding of healing process is still incomplete, but it is well known that platelets play an important role in both hemostasis and wound healing processes.

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
Single (Outcomes Assessor)

入排标准

年龄范围
28 Years 至 55 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Systemically healthy chronic periodontitis patients
  • Presence of one tooth with probing depth (PD) and clinical attachment loss (CAL) ≥5 mm associated with an interdental intrabony defect depth of≥3 mm.
  • Only patients with optimal compliance, as assessed during the cause-related phase of therapy, will be selected.
  • Cause related therapy (CRT) including scaling and root planning will be performed and oral hygiene instructions will be given to all the study subjects.

排除标准

  • Systemic illness (chronic inflammatory diseases like diabetes mellitus, arthritis, history of viral infection or pyrexia over the past one month) known to affect the periodontium or outcome of periodontal therapy.
  • Patient taking medications such as corticosteroids or calcium channel blockers, which are known to interfere periodontal wound healing or patient on long term NSAID therapy.
  • Patients having history of receiving antibiotics or periodontal treatment over the past 3 months.
  • Patients allergic to medication (local anaesthetic, antibiotics, NSAID).
  • Pregnant or lactating mothers.
  • Smokers and tobacco chewers.
  • Fractured/perforated roots.
  • Teeth with mobility greater than grade II (Miller 1943) and furcation involvement (class II and class III, Glickman 1953) or with clinical signs of untreated acute infection at surgical site, apical pathology, and severe root irregularities will be excluded.

结局指标

主要结局

PD

时间窗: 6 months

pocket depth

CAL

时间窗: 6 months

clinical attachment level

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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