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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03104764
• Date of registration: 03/04/2017
• Prospective Registration: No
• Primary sponsor: Public Dental Health in Uppsala Region
• Public title: Labial Frenulum Surgery - a Comparative Study of Conventional Scalpel and Er-Yag Laser Technique
• Scientific 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
• Date of first enrolment: August 1, 2014
• Target sample size: 40
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03104764
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Sweden

Key inclusion & exclusion criteria

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



Age minimum: 7 Years
Age maximum: 15 Years
Gender: All

Health Condition(s) or Problem(s) studied

Labial Tie

Intervention(s)

Device: Er:YAG laser

Device: Scalpel

Primary Outcome(s)

Wound healing [Time Frame: 0-3 months]

Secondary Outcome(s)

Patient experience [Time Frame: 0-3 months]

Scar tissue formation [Time Frame: 3 months]

Time required for surgery [Time Frame: Intervention day]

Secondary ID(s)

Dnr 2014/253

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Göteborg University, Sweden