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临床试验/NCT06508476
NCT06508476已完成4 期

The Efficacy of Amnion Chorion Allograft in Management of Type 1 Gingival Recession. (Randomized Clinical Trial)

Minia University1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2024年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
28
试验地点
1
主要终点
recession depth

研究概览

简要总结

the main goal of this clinical trial is to test the efficacy of amnion Chorion allograft in managing gingival recession. The main questions it aims to answer are: Is it effective in treating gingival recession, and how it compares to connective tissue graft.

详细描述

Gingival recession (GR) is characterized by apical migration of soft tissue margin beyond the cemento-enamel junction (CEJ) or the platform of an implant.

Gingival recession is a common daily finding in every practice. As patients are more concerned with a pleasing smile, root exposure is a growing concern . Moreover, discomfort and inability to perform oral hygiene result from exposed root hypersensitivity. It affects the patient's abilities to maintain adequate plaque control which eventually complicates the situation more. It is advisable to augment tissues and increase keratinized tissue (KT) band to reduce discomfort and obtain an aesthetic smile.

multiple treatment modalities are available for treating gingival recession such as Pedicle flaps (coronally advanced flap (CAF), semilunar flap, laterally sliding flap (lSD), and double papilla flap), Free gingival graft (FGG), Subepithelial connective tissue graft (SCTG), Guided tissue regeneration. Modified coronally advanced tunnel, Vestibular incision subperiosteal tunnel access (VISTA), Pinhole technique (PST).

Size and number of recession defects, KT band, interproximal attachment level, depth vestibule and frenum pull are among factors to determine which procedure is suitable for that type of recession.

For single-type recession (localized or isolated), the use of CAF with SCTG is favorable for both root coverage and KT gain. According to the American Academy of Periodontology regeneration workshop "for Miller class 1 and 2 single-tooth recession defects, SCTG procedures provide the best outcome ". Using CAF combined with SCTG is considered the gold standard treatment for localized recession defects. SCTG improves root coverage, KT gain, and clinical attachment levels. Using SCTG helps stabilize CAF, increase root coverage predictability, and increase soft tissue thickness. CAF with SCTG is a predictable technique to increase root coverage, decrease recession depth, and increase KT width and thickness.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
25 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Selected patients of both sexes are 25-45 years old.
  • Patients are systemically healthy based on the questionnaire dental modification of the Cornell index.
  • O'Leary index (1972) is less than 10% (the surgical therapy is not initiated until the patient reaches the 10% level or less of plaque accumulation).
  • Buccal recession defects are classified RT1 according to Cairo's classification (2011).
  • Clinical indication and/or patient request for recession coverage.

排除标准

  • RT2 and RT3 recession defects.
  • Pregnant female.
  • Patients with special needs or with any mental problems.
  • All patients are using any kind of medication that could interfere with the healing of periodontal tissues. Such as chemotherapy and radiotherapy.
  • Teeth with root carious lesions.
  • Rotated and extruded teeth.
  • Patients underwent any prior periodontal surgery in the relevant region.

研究组 & 干预措施

Amnion chorion allograft

Experimental

participants will receive amnion chorion with coronally advanced flap

干预措施: Amnion Chorion membrane (Biological)

Connective tissue graft

Active Comparator

participants will receive connective tissue graft with coronally advanced flap

干预措施: connective tissue graft (Procedure)

结局指标

主要结局

recession depth

时间窗: changes in millimeters from base line to follow up after 6 months

recession depth is measured from CEJ to the gingival margin in millimeters.

次要结局

  • Probing pocket depth(changes in millimeters from base line to follow up after 6 months)
  • Recession Width(changes in millimeters from base line to follow up after 6 months)
  • the height of keratinized gingiva(changes in millimeters from base line to follow up after 6 months)
  • percentage of root coverage(changes in percentile from base line to follow up after 6 months)

研究者

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

Mina gerges

Principal investigator

Minia University

研究点 (1)

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