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

April 7, 2017 updated by: Public Dental Health in Uppsala Region

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden, SE-75017
        • Public Dental Service, Vretgränd 9

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 15 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Scalpel
Frenotomy performed with conventional scalpel
Device: Scalpel
Labial frenulum removed by scalpel
EXPERIMENTAL: Er:YAG laser
Frenotomy performed with Er:YAG laser
Device: Er:YAG laser
Labial frenulum removed by Er:YAG laser

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound healing
Time Frame: 0-3 months
Time period until reepithelialized measured clinically and on photos
0-3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Public Dental Health in Uppsala Region

Collaborators

Göteborg University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 1, 2014

Primary Completion (ACTUAL)

November 4, 2015

Study Completion (ACTUAL)

January 25, 2016

Study Registration Dates

First Submitted

April 3, 2017

First Submitted That Met QC Criteria

April 3, 2017

First Posted (ACTUAL)

April 7, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 11, 2017

Last Update Submitted That Met QC Criteria

April 7, 2017

Last Verified

September 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Dnr 2014/253

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data are not planned to be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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