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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Labial Tie

Intervention / Treatment
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* Device: Scalpel
* Device: Er:YAG laser


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective, randomized, controlled, single-blind investigation
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Scalpel<br>Frenotomy performed with conventional scalpel | Device: Scalpel<br>* Labial frenulum removed by scalpel<br>|
| Experimental: Er:YAG laser<br>Frenotomy performed with Er:YAG laser | Device: Er:YAG laser<br>* Labial frenulum removed by Er:YAG laser<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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labial frenulum, surgery, scalpel technique, Er:YAG laser