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临床试验/NCT07671274
NCT07671274招募中1 期

Comparison of the Efficacy of Conventional Versus Minimally Invasive Non-Surgical Periodontal Therapy in Periodontitis Patients (Randomized Controlled Clinical Trial)

Mansoura University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年8月5日最近更新:
适应症

试验速览

阶段
1 期
状态
招募中
入组人数
30
试验地点
1
主要终点
Plaque index (PI)

研究概览

简要总结

the aim of this study is to investigate the clinical outcomes of Minimally Invasive Non-Surgical Therapy(MINST) compared to Conventional non-surgical periodontal therapy (CNST)

详细描述

A total of thirty patients were included in the study, Inclusion Criteria: -

  • Patients with stage III pericdontitis, according to the American Academy of Periodontology (AAP) and the European Federation of Periodontology (EFP) periodontal classification system .
  • Medically free patients.
  • Non-smokers
  • Patients with good oral hygiene. Exclusion Criteria: -
  • Pregnant or lactating females.
  • Patients with systemic diseases that might affect periodontal health
  • previous periodontal treatment within 6 months before baseline examination.
  • prior antibiotic regimen use within 1 month before baseline examination All participants will receive oral hygiene instructions including toothbrushin, interdental cleaning, and plaque control behavior reinforcement with oral hygiene self-care regimens to be followed at home.
  • On the conventional non-surgical periodontal therapy side, a power-driven piezo•electric ultrasonic scaling device with scaling tips will be used the majority of the time to debride subgingival biofilm and calculus. and manual standard gracey curette instruments will be used to refine residuals from root surfaces.
  • Conversely, the treatment protocol of the minimally invasive non-surgical periodontal therapy side will be followed as in the previous study (5).
  • Briefly. the root surface of teeth will be thoroughly debrided by a minimally invasive approach using specific thin and delicate piezo-electric scaling tips (Woodpecker � Tip P3. Am Perfect sp. z o .• � Poland) and manual miniature periodontal curettes {� Dent Solutions. Cairo. Egypt) for reducing periodontal tissue trauma. Adjunctive use of magnification loupes will be performed.
  • Both modalities will be performed under local anesthesia.
  • All patients will be recalled 1 and 3 months after tre.alment for re-ev.almtion and professional supra-gingival plaque control

study parameters are plaque index bleeding of probing periodontal pocket depth clinical attachment loss gingival index

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • • Patients with stage III pericdontitis, according to the American Academy of Periodontology (AAP) and the European Federation of Periodontology (EFP) periodontal classification system .
  • Medically free patients.
  • Non-smokers
  • Patients with good oral hygiene.

排除标准

  • Pregnant or lactating females.
  • Patients with systemic diseases that might affect periodontal health
  • previous periodontal treatment within 6 months before baseline examination.
  • prior antibiotic regimen use within 1 month before baseline examination

结局指标

主要结局

Plaque index (PI)

时间窗: basline, 1 month , 3 months

1\. Plaque index (PI):The index assigns a score to each tooth based on the amount of plaque present. 0: No plaque is visible. 1. A thin film of plaque is present at the gingival margin (gumline) and can be detected with a probe. 2. Visible plaque along the gingival margin. 3. Heavy plaque accumulation in the gingival margin and interdental spaces.

Bleeding on probing (BOP):

时间窗: baseline, 1 month , 3 months

): "0" if no bleeding occurred within 10 second, and "1" if there was bleeding within 10 second.

Probing pocket Depth (PPD)

时间窗: baseline , 1 month , 3 month

): will be measured from the gingival margin to the base of the periodontal pocket.

Clinical Attachment Level (CAL)

时间窗: baseline ,1 month , 3 month

will be measured from the cement-enamel junction to the base of the periodontal pocket.

次要结局

未报告次要终点

研究者

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

Fatma saad saad mahmoud elsherbini

PhD, Lecturer, Oral Medicine, Periodontology, Diagnosis, and Oral Radiology Department,

Mansoura University

研究点 (1)

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