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Clinical Trials/NCT07334015
NCT07334015
Completed
Not Applicable

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

Suez Canal University1 site in 1 country16 target enrollmentStarted: September 10, 2024Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
16
Locations
1
Primary Endpoint
Change in Gingival Display (mm)

Overview

Brief Summary

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

Detailed Description

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 30 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Exclusion Criteria

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

Arms & Interventions

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

Intervention: 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.

Intervention: Modified lip repositioning (Procedure)

Outcomes

Primary Outcomes

Change in Gingival Display (mm)

Time Frame: 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.

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Leen somaf

Dr

Suez Canal University

Study Sites (1)

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