Clinical trial NCT06331325: Comparison of Frenotomy and Frenectomy Techniques for Management of High Frenum Attachment in Adults
Official title: Clinical Comparison of Frenotomy and Frenectomy Surgical Techniques for Management of High Frenum Attachment in Adult Patients: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: High Frenum Attachment
Keywords: frenum, labial
frenectomy
Lead sponsor: October University for Modern Sciences and Arts
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial. Allocation Ratio: 1:1
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Rebound / Relapse.
timeFrame: 6 months
Secondary outcomes:
measure: Postoperative pain
timeFrame: 1 week
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: MSA University
Study officials:
affiliation: Modern Sciences & Arts University
name: Nada Zazou, PHD
role: PRINCIPAL_INVESTIGATOR
References: