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

NCT ID: NCT06331325

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-20
• Study Completion Date: 2025-12-15

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.

Detailed Description

Frenum is a triangular thin folded mucus membrane with underlying connective tissue and muscular fibers that attaches the lips and cheeks with alveolar mucosa enhancing the stability of the lip (Newman et al., 2020).

High frenum attachment can have numerous negative effects when highly attached close to the gingival margin including gingival recession, papilla loss, and obliteration of the sulcus, which might enhance plaque accumulation indirectly by hindering tooth brushing. It may also be responsible for midline diastema (Miller, 1985).

According to Mirko et al. (1974), there are four different types of labial frenal attachments: mucosal, gingival, papillary, and papilla piercing. The mucosal form is the most common and predominates in the mandible (Jańczuk & Banach, 1980).

Frenectomy procedure involves the complete removal of the frenum along with its attachment to the underlying bone. Frenotomy procedure is the incision and relocation of the frenal attachments to a more apical level (Dibart & Karima, 2008). However, this procedure is not well-documented in the literature and little is known about its expected relapse rates.

The rationale for conducting the research:

The traditional frenectomy procedure as described by Archer (1961) and Kruger (1964) could be considered invasive and may lead to scarring, delayed healing, and loss of the interdental papilla due to bone exposure and complete removal of fibers which may have negative esthetic outcome in addition to the frequent relapse rate (Devishree et al., 2012). A systematic review (Delli et al., 2013) discussed some complications that may arise when performing frenectomy procedure such as scar formation, postoperative pain, and swelling. Thus, frenectomy is considered a radical procedure with potential complications.

In contrast, frenotomy could be introduced as a more conservative procedure that can achieve the same outcomes with lower postoperative complications and scar formation. To the best of our knowledge, no studies are comparing both techniques in terms of relapse rate and postoperative pain.

Thus, the rationale of our study is to evaluate the clinical effectiveness of frenotomy procedure and its effect on frenum relapse and postoperative pain compared to the conventional frenectomy procedure.

Conditions

High Frenum Attachment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Frenotomy procedure

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.

Group Type: EXPERIMENTAL

Frenotomy

Intervention Type: PROCEDURE

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

Frenectomy procedure

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.

Group Type: ACTIVE_COMPARATOR

Frenectomy

Intervention Type: PROCEDURE

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

Interventions

Frenotomy

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

Intervention Type: PROCEDURE

Frenectomy

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

Intervention Type: PROCEDURE

Other Intervention Names

Frenal relocation

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

October University for Modern Sciences and Arts

OTHER

Sponsor Role: lead

Responsible Party

Nada Zazou

Lecturer of Periodontology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nada Zazou, PHD

Role: PRINCIPAL_INVESTIGATOR

Modern Sciences & Arts University

Locations

MSA University

Giza, , Egypt

Countries

Egypt

Other Identifiers

724

Identifier Type: -

Identifier Source: org_study_id