NCT07334015

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 19, 2025

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2025

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 10, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 12, 2026

Completed
Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

1.2 years

First QC Date

December 10, 2025

Last Update Submit

January 5, 2026

Conditions

Excessive Gingival Display

Outcome Measures

Primary Outcomes (1)

  • Change in Gingival Display (mm)

    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.

    Up to 9 months

Secondary Outcomes (4)

  • Pain score

    Up to 9 months

  • Patient Satisfaction Score

    Up to 9 months

  • Signs of infection

    Up to 9 months

  • Surgical Time

    During surgery

Study Arms (2)

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

Procedure: z plasty frenectomy

control group : modified lip repositioning

EXPERIMENTAL

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

Procedure: Modified lip repositioning

Interventions

z plasty frenectomyPROCEDURE

Z-plasty frenectomy is a surgical procedure in which the frenum is released and rearranged using a Z-shaped incision. This technique helps improve tissue mobility and reduce tension. The procedure is performed under local anesthesia"

Also known as: Z Plasty
study group: z plasty frenectomy
Modified lip repositioningPROCEDURE

"Modified lip repositioning is a minimally invasive surgical technique used to reduce excessive gingival display. The procedure involves removing a small strip of mucosa and repositioning the upper lip to limit its upward movement during smiling. It is performed under local anesthesia ."

Also known as: lip repositioning, gummy smile
control group : modified lip repositioning

Eligibility Criteria

Age18 Years - 30 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Suez Canal University

Ismailia, Egypt

Location

Related Publications (1)

  • Tatakis DN. Lip Repositioning Techniques and Modifications. Dent Clin North Am. 2022 Jul;66(3):373-384. doi: 10.1016/j.cden.2022.02.002. Epub 2022 Jun 1.

    PMID: 35738733BACKGROUND

Related Links

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 2 groups 16 patient in each group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 10, 2025

First Posted

January 12, 2026

Study Start

September 10, 2024

Primary Completion

November 19, 2025

Study Completion

November 30, 2025

Last Updated

January 12, 2026

Record last verified: 2026-01

Locations

EG(1)