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临床试验/NCT06772506
NCT06772506已完成不适用

Clinical and Patient-centered Outcomes After Minimally Invasive Non-surgical Therapy for the Treatment of Splinted Stage IV Periodontitis - Randomized Controlled Clinical Trial

Minia University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年8月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
1
主要终点
CAL by millimeters

研究概览

简要总结

Conventional periodontal treatment typically involves a combination of non-surgical and surgical approaches, such as scaling and root planing, followed by flap surgery and guided tissue regeneration. While these methods have demonstrated some success in managing periodontal disease, the low success rate in complex cases has prompted the exploration of alternative treatment modalities. One such approach is minimally invasive, non-surgical monotherapy, which aims to address the etiological source of the inflammation without the need for invasive surgical intervention.

Guided tissue regeneration, a well-established technique in periodontal treatment, employs physical barrier membranes to exclude the proliferation of unwanted gingival fibroblasts and allow the regeneration of tooth-supporting structures such as the alveolar bone, periodontal ligament, and cementum.

Recent advancements in dental therapies have led to the exploration of minimally invasive non-surgical approaches that aim to achieve comparable outcomes with reduced morbidity. This protocol outlines a randomized clinical trial to evaluate the efficacy and safety of a minimally invasive non-surgical monotherapy in treating patients with stage 4 periodontitis.

Is minimally invasive non-surgical technique more effective in reducing tooth mobility and improving clinical parameters than conventional non-surgical technique?

详细描述

Periodontitis is a chronic inflammatory disease that affects the supporting structures of the teeth, including the gingiva, periodontal ligament, cementum, and alveolar bone. The advanced stages of periodontitis, such as stage 4, are characterized by severe tissue destruction, deepened pocket depths, and alveolar bone loss, which can ultimately lead to tooth mobility, drifting, and loss. Effective therapeutic interventions are necessary to halt the progression of the disease and potentially regenerate the lost periodontal tissues.

Conventional periodontal treatment typically involves a combination of non-surgical and surgical approaches, such as scaling and root planing, followed by flap surgery and guided tissue regeneration. While these methods have demonstrated some success in managing periodontal disease, the low success rate in complex cases has prompted the exploration of alternative treatment modalities. One such approach is minimally invasive, non-surgical monotherapy, which aims to address the etiological source of the inflammation without the need for invasive surgical intervention.

Guided tissue regeneration, a well-established technique in periodontal treatment, employs physical barrier membranes to exclude the proliferation of unwanted gingival fibroblasts and allow the regeneration of tooth-supporting structures such as the alveolar bone, periodontal ligament, and cementum.

Recent advancements in dental therapies have led to the exploration of minimally invasive non-surgical approaches that aim to achieve comparable outcomes with reduced morbidity. This protocol outlines a randomized clinical trial to evaluate the efficacy and safety of a minimally invasive non-surgical monotherapy in treating patients with stage 4 periodontitis.

Is minimally invasive non-surgical technique more effective in reducing tooth mobility and improving clinical parameters than conventional non-surgical technique?

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)

盲法说明

investigator

入排标准

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

入选标准

  • •periodontitis stage III and IV
  • •Mobility grade 2
  • •age from 18-55 years
  • •medically free
  • •nonsmoker
  • •Single-rooted teeth

排除标准

  • •Medically compromised patient
  • •Bad oral hygiene
  • •Non-surgical or surgical periodontal treatment in the past 12months.
  • •Prolonged treatment with antibiotics or anti-inflammatory agents within 6months before periodontal therapy.

研究组 & 干预措施

conventional periodontal treatment with ultrasonic device and manual instruments

Experimental

conventional non-surgical techniques with ultrasonic and manual scaler instruments

干预措施: Non Surgical Periodontal Treatment includes post operative mouth wash with Listerine® (ethanol 21.6%, methyl salicylate 0.06%, menthol 0.042%, thymol 0.064% and eucalyptol 0.092%) (Procedure)

Placebo minimally invasive non surgical technique with mini five and after five instruments

Placebo Comparator

and minimally invasive non-surgical technique using mini five and after five instruments+ ultrasonic device for supragingival instrumentation

干预措施: Minimally invasive non-surgical technique with mini five and after five minimally invasive instrument plus splint (Procedure)

结局指标

主要结局

CAL by millimeters

时间窗: baseline, 3months and 6 months

Clinical attachment loss

次要结局

未报告次要终点

研究者

发起方
Minia University
申办方类型
Other
责任方
Principal Investigator
主要研究者

shaimaa hamdy

lecturer in department of periodontology

Nahda University

研究点 (1)

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