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

High Frenum Attachment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06331325
• Other study ID #: 724
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2024
• Est. completion date: September 30, 2024

Study information

• Verified date: March 2024
• Source: October University for Modern Sciences and Arts
• Contact: Nada Zazou, PHD
• Phone: +201224016945
• Email: drzazou[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• High Frenum Attachment

Intervention

Procedure:
• Frenotomy
Partial thickness procedure aiming to relocate high frenum attachment to a more apical level.
• Frenectomy
Full-thickness excision of the frenum down to the bone level and suturing by achieving primary closure.

Locations

Country	Name	City	State
Egypt	MSA University	Giza

Sponsors (1)

Lead Sponsor	Collaborator
October University for Modern Sciences and Arts

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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