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临床试验/NCT07822659
NCT07822659尚未招募不适用

Clinical and 3D Radiographic Evaluation of Minimally Invasive Non-Surgical Therapy Versus Single Flap Approach in Management of Periodontal Intrabony Defects: A Randomized Clinical Trial

Cairo University0 个研究点目标入组 40 人开始时间: 2026年9月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
40
主要终点
CAL gain

研究概览

简要总结

This study aims to evaluate the clinical and 3D radiographic effects of minimally invasive non-surgical periodontal therapy (MINST) compared to single flap approach (SFA) in management of intrabony defects in stage III or IV periodontitis patients.

详细描述

Minimally invasive non-surgical therapy (MINST) offers a tissue-preserving, patient-friendly approach that reduces morbidity, chair-time, and postoperative complications. However, existing studies on MINST are limited in scale, often lack long-term follow-up, and vary in clinical protocols, leading to inconsistent evidence on its predictability and efficacy compared to surgical modalities (Nibali et al., 2015; Barbato et al., 2024). Moreover, the biological mechanisms underlying MINST, particularly its ability to facilitate stable blood clot formation and support periodontal regeneration, are not yet fully clarified (Mehta et al., 2024). Given the growing emphasis on cost-effective, patient-centered care and the increasing population of individuals with medical or psychological contraindications to surgery, a deeper investigation into MINST as a stand-alone treatment is both timely and critical.

While MINST has emerged as a promising approach for managing periodontal intrabony defects, a critical limitation of current evidence lies in the lack of detailed characterization of defect morphology. Due to the non-surgical nature of the approach, the precise configuration of the defects; including their depth, width, angulation, and number of remaining bony walls, often remains undetermined, which restricts the ability to correlate defect characteristics with clinical outcomes. This is significant because it is well-established that defect morphology plays a crucial role in the success of regenerative periodontal treatments (Kasaj et al., 2008). Without detailed radiographic assessment, particularly using preoperative three-dimensional imaging modalities such as CBCT, it is challenging to ascertain which defect types are most suitable for MINST versus those that may benefit more from surgical intervention (Anoixiadou et al., 2023).

Consequently, there is a clear need for studies integrating preoperative 3D evaluation to better define the indications, advantages, and limitations of MINST in relation to defect-specific anatomical variables. Nonetheless, as periodontal therapy shifts toward less invasive, patient-centered care models, evaluating the efficacy of MINST with robust morphological diagnostics becomes an essential step in optimizing treatment outcomes and guiding evidence-based clinical decision-making.

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
25 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Stage III or IV periodontitis patient having at least one tooth with 2-wall, 3-wall, or combined 2- to 3-wall intrabony defect ≥ 3 mm in depth (assessed by bone sounding, radiographic examination) with pocket depth (PD) ≥ 6 mm.
  • Able to sign an informed consent form.
  • Patients who are cooperative, motivated, and hygiene conscious.
  • Systemically free according to Cornell Medical Index (Broadbent, 1951).

排除标准

  • Pregnancy or breast feeding
  • Smoking (current or in the past 5 years).
  • The presence of an orthodontic appliance
  • Periodontal therapy carried out in the past 6 months
  • History of intake of antibiotics or other medications affecting the periodontium in the previous 3 months.
  • Handicapped and patients with psychological conditions.

研究组 & 干预措施

Intervention

Experimental

Arm 1

干预措施: minimally invasive non-surgical therapy (Procedure)

Control

Active Comparator

arm 2

干预措施: minimally invasive periodontal surgery (Procedure)

结局指标

主要结局

CAL gain

时间窗: Baseline, 3 months and 6 months

Clinical attachment level (CAL) gain - Clinical examinations using UNC-15 Periodontal probe at baseline, 3 months and 6 months postoperatively. CAL will be measured in millimeters from the CEJ to the bottom of the gingival sulcus/periodontal pocket at six sites per tooth: mesio-buccal, mid-buccal, disto-buccal, mesio-lingual, mid-lingual, and disto-lingual surfaces. \*Higher scores (mm) indicate worse outcome.

次要结局

  • Radiographic defect depth reduction (RDR)(Baseline and 6 months)
  • Plaque index(Baseline, 3 months and 6 months)
  • Bleeding on Probing(Baseline, 3 months and 6 months)
  • Pocket depth (PD) reduction(Baseline, 3 months and 6 months)
  • Chair time(Baseline)
  • Healing(1 week and 8 weeks postoperative)
  • Oral health-related quality of life(1 week postoperative)
  • Cost effectiveness(6 months)
  • Visual Analog Scale (VAS) pain score(1-week postoperative)
  • Post-operative patient satisfaction(6-month postoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Israa Bakri

Principal Investigator

Cairo University

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