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临床试验/NCT06044727
NCT06044727已完成不适用

Comparative Evaluation Of the Restorative Capacity Of Marginal Gingiva Using MINST and Conventional Subgingival Instrumentation Involving RT1 Gingival Recession: A Randomized Controlled Clinical Trial

Postgraduate Institute of Dental Sciences Rohtak2 个研究点 分布在 1 个国家目标入组 54 人开始时间: 2023年9月25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
54
试验地点
2
主要终点
Root Coverage %

研究概览

简要总结

Gingival recession is a common condition and its extent and prevalence increase with age. Majority of patients probably present with localized and shallow gingival recession that need a specific treatment because they are susceptible to further apical displacement of gingival margin. So if gingival recession is detected early, removal of causative factors and non surgical treatments initiated then it can prevent more advanced mucogingival defects. Studies have shown that non surgical periodontal therapy including proper oral hygiene instructions, periodic scaling and root planning obtained successful root coverage in shallow gingival recession. Minimal invasive non surgical periodontal therapy (MINST)uses the delicate instruments and magnifying loupes performing periodontal debridement with more effective calculus and biofilm removal and less soft tissue trauma , maintain the tissue architecture, benefit the healing phase, improve the clinical results and increase visibility. There is no study to evaluate efficacy of MINST versus conventional subgingival instrumentation in the restorative capacity of marginal gingival in RT1 gingival recession , so the present study will be conducted to compare and evaluate the efficacy of minimal invasive non surgical periodontal therapy (MINST) and conventional subgingival instrumentation in the restorative capacity of marginal gingiva involving RT1 gingival recession.

详细描述

TITLE:

"Comparative Evaluation Of the Restorative Capacity Of Marginal Gingiva Using Minimal Invasive Non-Surgical Periodontal Therapy and Conventional Subgingival Instrumentation Involving RT1 Gingival Recession : A Randomized controlled clinical trial."

RATIONALE:

Gingival recession is a common condition and its extent and prevalence increase with age. Majority of patients probably present with localized and shallow gingival recession that need a specific treatment because they are susceptible to further apical displacement of gingival margin. So if gingival recession is detected early, removal of causative factors and non surgical treatment initiated then it can prevent more advanced mucogingival defects. Studies have shown that non surgical periodontal therapy including proper oral hygiene instructions, periodic scaling and root planning obtained successful root coverage in shallow gingival recession. Minimal invasive non surgical periodontal therapy (MINST)uses the delicate instruments and magnifying loupes performing periodontal debridement with more effective calculus and biofilm removal and less soft tissue trauma , maintain the tissue architecture, benefit the healing phase, improve the clinical results and increase visibility. There is no study to evaluate efficacy of MINST versus conventional subgingival instrumentation in the restorative capacity of marginal gingival in RT1 gingival recession , so the present study will evaluate the same.

AIM:

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 (Investigator)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Gingival Recession Type 1(RT1) by Cairo et al 2011in esthetic zone including maxillary and mandibular anteriors and premolars, otherwise systemically healthy
  • Gingival Recession ≤3mm associated with plaque induced inflammation and identifiable CEJ
  • Age 20 years to 50 years
  • Providing a written and verbal informed consent.

排除标准

  • Patient with systemic disease that can influence the outcome of therapy.
  • Pregnant females or on oral contraceptive pills or hormone replacement therapy.
  • Smokers and patients undergoing orthodontic therapy
  • Physically and mentally impaired patients.
  • Non vital, mal-positioned tooth
  • Presence of cervical abrasions or restorations in the area
  • Previous history of periodontal surgery on the involved sites.

结局指标

主要结局

Root Coverage %

时间窗: 6 months

Will be calculated according to the formula Root Coverage percentage =Recession depth(preop -postop)\*100/Recession depth preoperative

Recession Width

时间窗: 6 months

recorded in mm with a periodontal probe from the mesial to distal gingival margin at the level of cementoenamel junction.

Recession Depth

时间窗: 6 months

recorded in mm with a periodontal probe from the cementoenamel junction to the crest of the gingival margin at mid labial region.

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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