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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03104764

Enrollment

Registered

2017-04-07

Start date

2014-08-01

Completion date

2016-01-25

Last updated

2017-04-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labial Tie

Keywords

labial frenulum, surgery, scalpel technique, Er:YAG laser

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.

Interventions

DEVICEScalpel

Labial frenulum removed by scalpel

DEVICEEr:YAG laser

Labial frenulum removed by Er:YAG laser

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Masking description

The outcome assessor have not met the patient before assessing the outcome. The assessor has no information about which surgical technique that is used.

Intervention model description

Prospective, randomized, controlled, single-blind investigation

Eligibility

Sex/Gender

ALL

Age

7 Years to 15 Years

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

Design outcomes

Primary

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

Secondary

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

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026