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

Public Dental Health in Uppsala Region

Status: Completed

Conditions: Labial Tie

Treatments: Device: Er:YAG laser; Device: Scalpel

Study type: Interventional

Funder types: Other

Identifiers

NCT03104764

Dnr 2014/253

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 7 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Scalpel

Active Comparator group

Description:

Frenotomy performed with conventional scalpel

Treatment:

Device: Scalpel

Er:YAG laser

Experimental group

Description:

Frenotomy performed with Er:YAG laser

Treatment:

Device: Er:YAG laser