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

NCT06331325 | Completed

• 1 other identifier: 724
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

frenum, labial; frenectomy

Outcome Measures

Primary Outcomes (1)

• Rebound / Relapse.

  The level of the frenum will be measured at baseline and follow-up using William's graduated periodontal probe. The incisal edge will be assigned as a reference point at baseline to measure the frenum level before and after the procedure and identify the change in level.

  6 months

Secondary Outcomes (1)

• Postoperative pain

  1 week

Study Arms (2)

Frenotomy procedure

EXPERIMENTAL

Two C-shaped partial thickness incisions are performed on the two sides of the frenum leaving the underlying periosteum intact. Relocation of the muscle attachment is performed by blunt dissection using a mucoperiosteal elevator. Undermining or separation of the epithelium from the underlying lip mucosa is then performed by blunt dissection to facilitate tension-free suturing. The epithelium is then sutured to the underlying periosteum using three interrupted periosteal sutures and is left to heal by secondary intention.

Procedure: Frenotomy

Frenectomy procedure

ACTIVE COMPARATOR

Frenectomy group (Control): Two full-thickness incisions are performed apical and coronal to the frenum attachment and extending down to and including the periosteum. Complete excision of all muscle tissues is ensured and then both epithelial edges are approximated using single interrupted sutures achieving primary closure.

Procedure: Frenectomy

Interventions

Frenotomy PROCEDURE

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

Also known as: Frenal relocation

Frenotomy procedure

Frenectomy PROCEDURE

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

Frenectomy procedure

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults with active highly attached maxillary/mandibular labial frenum.
• Systemically healthy
• Non-smokers
• Gingival and plaque index \<10%

You may not qualify if:

• Poor oral hygiene.
• Smokers
• Any systemic diseases or medications that delay wound healing.
• Pregnant or lactating females
• Previous frenal procedures.

Sponsors & Collaborators

• October University for Modern Sciences and Arts: lead

Study Sites (1)

MSA University

Giza, 12566, Egypt

Location

MeSH Terms

Interventions

Oral Frenectomy

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures; Surgical Procedures, Operative; Dentistry

Study Officials

• Nada Zazou, PHD

  Modern Sciences & Arts University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors will be unaware of the recruitment group. The allocation sequence will be contained within sequentially numbered, opaque, sealed packets that the patients will pull. According to the randomization table, the written number on the paper will allocate the patient to the intervention or control group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Periodontology

Model Details: Randomized clinical trial. Allocation Ratio: 1:1

Study Record Dates

• First Submitted: March 20, 2024
• First Posted: March 26, 2024
• Study Start: March 20, 2024
• Primary Completion: December 15, 2025
• Study Completion: December 15, 2025
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data is available
• Access Criteria: Shared upon request

Locations

EG (1)