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

NCT03104764 | Completed

• 1 other identifier: Dnr 2014/253
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Labial Tie

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Wound healing

  Time period until reepithelialized measured clinically and on photos

  0-3 months

Secondary Outcomes (3)

• Patient experience

  0-3 months

• Time required for surgery

  Intervention day

• Scar tissue formation

  3 months

Study Arms (2)

Scalpel

ACTIVE COMPARATOR

Frenotomy performed with conventional scalpel

Device: Scalpel

Er:YAG laser

EXPERIMENTAL

Frenotomy performed with Er:YAG laser

Device: Er:YAG laser

Interventions

Scalpel DEVICE

Labial frenulum removed by scalpel

Scalpel

Er:YAG laser DEVICE

Labial frenulum removed by Er:YAG laser

Er:YAG laser

Eligibility Criteria

• Age: 7 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• patients in need of frenulum labials surgery

You may not qualify if:

• patients with severe general diseases (ASA\>2)
• patients who required general anaesthesia for treatment

Sponsors & Collaborators

• Public Dental Health in Uppsala Region: lead
• Göteborg University: collaborator

Study Sites (1)

Public Dental Service, Vretgränd 9

Uppsala, SE-75017, Sweden

Location

MeSH Terms

Interventions

Laser Therapy; Lasers, Solid-State

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome assessor have not met the patient before assessing the outcome. The assessor has no information about which surgical technique that is used.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, controlled, single-blind investigation

Study Record Dates

• First Submitted: April 3, 2017
• First Posted: April 7, 2017
• Study Start: August 1, 2014
• Primary Completion: November 4, 2015
• Study Completion: January 25, 2016
• Last Updated: April 11, 2017

Record last verified: 2014-09

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)