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

NCT ID: NCT03104764

Last Updated: 2017-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-01
• Study Completion Date: 2016-01-25

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.

Conditions

Labial Tie

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Scalpel

Frenotomy performed with conventional scalpel

Group Type: ACTIVE_COMPARATOR

Scalpel

Intervention Type: DEVICE

Labial frenulum removed by scalpel

Er:YAG laser

Frenotomy performed with Er:YAG laser

Group Type: EXPERIMENTAL

Er:YAG laser

Intervention Type: DEVICE

Labial frenulum removed by Er:YAG laser

Interventions

Scalpel

Labial frenulum removed by scalpel

Intervention Type: DEVICE

Er:YAG laser

Labial frenulum removed by Er:YAG laser

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Göteborg University

OTHER

Sponsor Role: collaborator

Public Dental Health in Uppsala Region

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Public Dental Service, Vretgränd 9

Uppsala, , Sweden

Countries

Sweden

Other Identifiers

Dnr 2014/253

Identifier Type: -

Identifier Source: org_study_id