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Comparison of ER:YAG Laser, CO2 Laser and Scalpel Excision of Fibrous Hyperplasia on the Buccal Mucosa

NCT03001791 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2017-11-27

No results posted yet for this study

Summary

The aim of the RCT is to analyse clinical and histopathological particularities for excisional biopsies of fibrous hyperplasia in the buccal mucosa performed with Er:YAG laser, CO2 laser and scalpel. The primary outcome parameter is to evaluate the thermal damage zone on the excised specimens. Secondary parameters are time of surgery, intraoperative bleeding, the need for additional electrocoagulation or sutures and patient's postsurgical perception of pain, other postsurgical effects and use of analgesics.

Conditions

  • Fibrous Hyperplasia on Oral Mucosa

Interventions

PROCEDURE

Excisional biopsy with Er:YAG laser

Excisional biopsy of fibrous hyperplasia in the buccal mucosa in local anesthesia with Er:YAG laser (Lite TouchTM, Synergon Dental Lasers, Light instruments Ltd., Yokneam Elite, Israel), λ = 2940nnm. Soft tissue biopsy mode with water cooling, frequency 35 Hz, pulse duration 250-390 µsec, pulse energy of 200 mJ, power 7 Watt . Cylindrical sapphire tip, 400 µm in diameter, without contact to the tissue.

PROCEDURE

Excisional biopsy with CO2 laser

Excisional biopsy of fibrous hyperplasia in the buccal mucosa in local anesthesia with CO2 laser (Spectra DENTA Surgical Carbon Dioxide Laser, MAX Engineering Ltd., Gyeonggi-Do, Korea), λ = 10'600nnm. cf mode (frequency 140 Hz, pulse duration 400 µsec, pulse energy 33 mJ,a power 4.62 watts). Laser beam with a spot size of 0.2 mm, non-contact mode.

PROCEDURE

Excisional biopsy with scalpel

Excisional biopsy of fibrous hyperplasia in the buccal mucosa in local anesthesia with scalpel (blade 15C). Polyamide sutures (Seralon 5-DS15, Serag Wiessner KG, Naila, Germany).

Sponsors & Collaborators

  • University of Bern

    lead OTHER

Principal Investigators

  • Valerie GA Suter, Dr med dent · Department of Oral Surgery and Stomatology, Dental School, University of Bern

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-07-31
Primary Completion
2017-07-04
Completion
2017-08-10

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03001791 on ClinicalTrials.gov