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

Clinical Comparison of Frenotomy and Frenectomy Surgical Techniques for Management of High Frenum Attachment in Adult Patients: A Randomized Clinical Trial

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.

Study Overview

• Status: Completed
• Conditions: High Frenum Attachment
• Intervention / Treatment: Procedure: Frenotomy; Procedure: Frenectomy

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 12566
    • MSA University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Procedure: Frenotomy; Partial thickness procedure aiming to relocate high frenum attachment to a more apical level.; Other Names: Frenal relocation
Active Comparator: 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.	Procedure: Frenectomy; Full-thickness excision of the frenum down to the bone level and suturing by achieving primary closure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	A visual analog scale (VAS) will be recorded by the patients during the first week postoperatively to compare the postoperative pain experienced after both procedures.	1 week

Collaborators and Investigators

• Sponsor: October University for Modern Sciences and Arts
• Investigators: Principal Investigator: Nada Zazou, PHD, Modern Sciences & Arts University

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2024
• Primary Completion (Actual): December 15, 2025
• Study Completion (Actual): December 15, 2025

Study Registration Dates

• First Submitted: March 20, 2024
• First Submitted That Met QC Criteria: March 20, 2024
• First Posted (Actual): March 26, 2024

Study Record Updates

• Last Update Posted (Actual): January 20, 2026
• Last Update Submitted That Met QC Criteria: January 15, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: frenectomy; frenum, labial
• Additional Relevant MeSH Terms: Surgical Procedures, Operative; Dentistry; Oral Surgical Procedures; Oral Frenectomy
• Other Study ID Numbers: 724

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Study protocol, Statistical analysis.
• IPD Sharing Time Frame: Data is available
• IPD Sharing Access Criteria: Shared upon request
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No