Comparing two surgical techniques for 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
This study is testing whether a less invasive surgery for high frenum attachment can work as well as the traditional surgery in adults and if it leads to fewer problems afterward.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | October University for Modern Sciences and Arts Academic / other |
| Locations | 1 site (Giza) |
| Trial ID | NCT06331325 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of frenotomy and frenectomy surgical techniques in managing high frenum attachment in adults. Participants will be randomly assigned to either the frenotomy group, which involves incision and relocation of the frenum, or the frenectomy group, which entails complete removal of the frenum. The study will assess relapse rates and postoperative complications over a six-month period, with pain scores recorded during the first week post-surgery. The goal is to determine if the less invasive frenotomy technique offers advantages over the traditional frenectomy.
Who should consider this trial
Good fit: Ideal candidates are systemically healthy adults with active high frenum attachment who are non-smokers and maintain good oral hygiene.
Not a fit: Patients with poor oral hygiene, smokers, or those with systemic diseases that affect wound healing may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a less invasive surgical option with fewer complications for patients with high frenum attachment.
How similar studies have performed: While the frenectomy technique is well-established, the frenotomy approach is less documented, making this study a novel exploration in this area.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Giza
- MSA University — Giza, Egypt (Recruiting)
Study contacts
- Principal investigator: Nada Zazou, PHD — Modern Sciences & Arts University
- Study coordinator: Nada Zazou, PHD
- Email: drzazou@hotmail.com
- Phone: +201224016945
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.