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OpenTrials
Completed

NCT Number: NCT03104764

Labial Frenulum Surgery - a Comparative Study of Conventional Scalpel 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.

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Key information

Conditions

Labial Tie

Age range

7 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Public Dental Service, Vretgränd 9

Uppsala, SE-75017, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Scalpel

Device

Labial frenulum removed by scalpel

Er:YAG Laser

Device

Labial frenulum removed by Er:YAG laser

Primary outcomes

  1. Wound healing

    Time frame: 0-3 months

    Time period until reepithelialized measured clinically and on photos

Secondary outcomes

  1. Patient experience

    Time frame: 0-3 months

    Patients´experiences of surgery procedures measured through questionnaires

  2. Time required for surgery

    Time frame: Intervention day

    The time required for the surgical process is measured with timer

  3. Scar tissue formation

    Time frame: 3 months

    prevalence of scar tissue formation assessed by a clinical investigation

Sponsors and collaborators

Lead sponsor

Public Dental Health in Uppsala Region

Other

Collaborators

  • Göteborg University

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Apr 7, 2017
Registry last updated
Apr 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.