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Comparison of Frenotomy and Frenectomy Techniques for Management of High Frenum Attachment in Adults

NCT06331325 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-01-20

No results posted yet for this study

Summary

The goal of this randomized clinical trial is to compare frenotomy to frenectomy surgical techniques in the management of high frenum attachment in adults. The main questions it aims to answer are:

* Does Frenotomy procedure have a lower relapse rate compared to frenectomy?
* Does Frenotomy procedure result in fewer postoperative complications? Participants will be divided into two groups. The intervention group will involve frenotomy procedure for participants and will be compared to the traditional frenectomy procedure in the comparator group. The level of the frenum will be measured at baseline and after 6 months. Pain scores will be recorded by the participants during the first week.

Conditions

  • High Frenum Attachment

Interventions

PROCEDURE

Frenotomy

Partial thickness procedure aiming to relocate high frenum attachment to a more apical level.

PROCEDURE

Frenectomy

Full-thickness excision of the frenum down to the bone level and suturing by achieving primary closure.

Sponsors & Collaborators

  • October University for Modern Sciences and Arts

    lead OTHER

Principal Investigators

  • Nada Zazou, PHD · Modern Sciences & Arts University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-03-20
Primary Completion
2025-12-15
Completion
2025-12-15

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06331325 on ClinicalTrials.gov