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

Labial Tie Clinical Trial

Official title:

Evaluation of Wound Healing and Patients´Experiences of Labial Frenulum Surgery - a Randomized, Controlled Comparative Study of Conventional Scalpel Technique and Er-Yag Laser Technique

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03104764
• Other study ID #: Dnr 2014/253
• Status: Completed
• Phase: N/A
• First received: April 3, 2017
• Last updated: April 7, 2017
• Start date: August 1, 2014
• Est. completion date: January 25, 2016

Study information

• Verified date: September 2014
• Source: Public Dental Health in Uppsala Region
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 25, 2016
• Est. primary completion date: November 4, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Labial Tie

Intervention

Device:
• Scalpel
Labial frenulum removed by scalpel
• Er:YAG laser
Labial frenulum removed by Er:YAG laser

Locations

Country	Name	City	State
Sweden	Public Dental Service, Vretgränd 9	Uppsala

Sponsors (2)

Lead Sponsor	Collaborator
Public Dental Health in Uppsala Region	Göteborg University, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Wound healing	Time period until reepithelialized measured clinically and on photos	0-3 months
Secondary	Patient experience	Patients´experiences of surgery procedures measured through questionnaires	0-3 months
Secondary	Time required for surgery	The time required for the surgical process is measured with timer	Intervention day
Secondary	Scar tissue formation	prevalence of scar tissue formation assessed by a clinical investigation	3 months