Labial Frenulum Surgery - a Comparative Study of Conventional Scalpel and Er-Yag Laser Technique

Not Applicable

Completed

• Conditions: Labial Tie
• Interventions: Device: Scalpel

• Registration Number: NCT03104764
• Lead Sponsor: Public Dental Health in Uppsala Region

Brief Summary

The aim of the study was to compare the outcome in terms of wound healing time, surgery time, bleeding and patient experience of the ectomy of frenulum when performed with laser technology versus conventional scalpel technique. A prospective, single-blind, randomized and controlled study was performed. Wound healing was assessed five and ten days after after surgery. The long-term outcome were assessed blinded by a dentist not earlier involved in the study.

Detailed Description

Children referred to a pediatric clinic to surgically remove a labial frenulum were randomized to treatment with conventional scalpel or laser treatment technology after parents and children had given consent to participate. During the surgery the time required for the procedure and the amount of bleeding the different techniques caused were measured. Wound healing was assessed five and ten days after surgery by a clinical judgement and by analysing photos. Three months after surgery an independent dentist assessed the long-term outcome by a clinical examination. The patients´ view of the treatment were assessed directly after the surgery and five days, ten days and three months after the surgery.

Study Timeline

• Study Start: 2014-08-01
• Status Verified: 2014-09
• Primary Completion: 2015-11-04
• Study Completion: 2016-01-25
• Study First Submitted: 2017-04-03
• Study First Submitted QC: 2017-04-03
• Study First Posted: 2017-04-07
• Last Update Submitted: 2017-04-07
• Last Update Posted: 2017-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• patients in need of frenulum labials surgery

Exclusion Criteria

• patients with severe general diseases (ASA>2)
• patients who required general anaesthesia for treatment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Scalpel	Scalpel	Frenotomy performed with conventional scalpel

Primary Outcome Measures

Name	Time	Method
Wound healing	0-3 months	Time period until reepithelialized measured clinically and on photos

Secondary Outcome Measures

Name	Time	Method
Patient experience	0-3 months	Patients´experiences of surgery procedures measured through questionnaires
Time required for surgery	Intervention day	The time required for the surgical process is measured with timer
Scar tissue formation	3 months	prevalence of scar tissue formation assessed by a clinical investigation

Trial Locations

Locations (1)

Public Dental Service, Vretgränd 9; 🇸🇪 Uppsala, Sweden