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临床试验/NCT03767309
NCT03767309Unknown不适用

Management of Miller Class I & II Gingival Recession Using Conventional Versus Abrasive De-epithelization of Palatal Graft

Halla Gamal Mohammed Esmail0 个研究点目标入组 20 人开始时间: 2019年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
20
主要终点
Direct Post-operative pain

研究概览

简要总结

Management of Miller class I & II gingival recession using coronally advanced flap combined with conventional de-epithelialized free gingival graft versus coronally advanced flap combined with abrasive de-epithelized connective tissue graft Null hypothesis: In patients with Miller class I and II gingival recession, there is no difference between coronally advanced flap with conventional de-epithelialized free gingival graft and coronally advanced flap with abrasive de-epithelized connective tissue graft in recession depth reduction.

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
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years.
  • Systemically healthy patients.
  • Miller's Class I and II recession defects with recession depth ≥ 2mm.
  • Presence of identifiable cemento-enamel junction (CEJ).
  • Clinical indication and/or patient request for recession coverage.
  • Smoking ≤ 10 cigarettes/day.
  • Cooperative patients able and accept to come for follow up appointments.

排除标准

  • Pregnant females.
  • Smoking ˃ 10 cigarettes/day.
  • Contraindication for periodontal surgery.
  • Patients with poor oral hygiene.
  • Recession defects associated with caries or restoration as well as
  • Teeth with evidence of a pulpal pathology
  • Molar teeth

研究组 & 干预措施

Test group

Experimental

SCTG will be harvested from the palate in the intervention group (coronally advanced flap and abrasively de-epithelialized free gingival graft)

干预措施: coronally advanced flap with abrasive de-epithelized graft. (Procedure)

Control group

Active Comparator

SCTG will be harvested from the palate using Zucchilli's technique (zucchelli, 2010) in the control group (coronally advanced flap and conventionally de-epithelialized free gingival graft)

干预措施: coronally advanced flap with de-epithelized graft. (Procedure)

结局指标

主要结局

Direct Post-operative pain

时间窗: 7 days

Directly will be evaluated post-surgically with Visual Analogue Scale with numbers from 0 to 10 that given to the patients at 7 days follow-up visits.

Indirect Post-operative pain

时间窗: 7 days

Indirectly will be evaluated on the basis of the mean consumption of analgesics

次要结局

  • Surgical chair time(at the time of surgery)
  • Complete Root Coverage(6 months)
  • Recession depth.(6 months)
  • Gingival Recession Width(6 months)
  • Root Coverage Esthetic Score(6 months)
  • Width Of Keratinized Gingiva(6 months)
  • Gingival thickness(6 months)

研究者

发起方
Halla Gamal Mohammed Esmail
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Halla Gamal Mohammed Esmail

Dentist

Cairo University

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