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临床试验/NCT07334015
NCT07334015已完成不适用

Assessment of Modified Lip Repositioning Surgery and Z Plasty Frenectomy for Treatment of Excessive Gingival Display

Suez Canal University1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2024年9月10日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
16
试验地点
1
主要终点
Change in Gingival Display (mm)

研究概览

简要总结

evaluate clinically the postoperative outcomes of the Z plasty frenectomy technique in comparison to modified lip repositioning surgery

详细描述

Excessive gingival display is a cosmetic problem where it is usually managed by different approaches such as lip repositioning.

Aim: Is to evaluate clinically the postoperative outcomes of the Z plasty frenectomy technique in comparison to modified lip repositioning surgery Methodology: The clinical study will include 16 patients with gummy smile divided into two groups equally and randomly according to technique using www.randomizer.org.

Group 1: will be treated with conventional modified lip repositioning technique and the labial frenum will be left intact.

Group 2: will be treated with z plasty frenectomy. Clinical follow up will be at 1,3, 6 and 9 months.

Clinical evaluation will be done through using (VAS). It will be used to measure patient satisfaction through pain killer scale . - Likert scale to measure patient satisfaction - Periodontal probe will be used to measure the relapse. Also signs of infection will be recorded.

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 (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female patients aged 18 to 30 years
  • ASA physical status I or II
  • Presence of excessive gingival display (gummy smile)
  • Indication for surgical treatment of excessive gingival display
  • Willingness to participate and attend follow-up visits

排除标准

  • Poor oral hygiene
  • Patients with active acute infection
  • Patients with poor oral habits
  • Pregnant or lactating women
  • Heavy smokers
  • Alcohol or drug addicts

研究组 & 干预措施

study group: z plasty frenectomy

Experimental

Participants in the study group will be treated with Z- plasty frenectomy and will be followed up for 9 months

干预措施: z plasty frenectomy (Procedure)

control group : modified lip repositioning

Experimental

Participants in the control group will undergo modified lip repositioning with a follow-up period of 9 months.

干预措施: Modified lip repositioning (Procedure)

结局指标

主要结局

Change in Gingival Display (mm)

时间窗: Up to 9 months

Gingival display will be assessed in millimeters using standardized clinical photographs taken at maximum smile. Measurements will be performed using a periodontal probe to determine the vertical distance between the inferior border of the upper lip and the gingival margin of the maxillary central incisors. A reduction in gingival display indicates improvement, while an increase indicates relapse. Measurements will be recorded at baseline and during follow-up visits.

次要结局

  • Pain score(Up to 9 months)
  • Patient Satisfaction Score(Up to 9 months)
  • Signs of infection(Up to 9 months)
  • Surgical Time(During surgery)

研究者

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

Leen somaf

Dr

Suez Canal University

研究点 (1)

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