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

University of Bern

Status: Completed

Conditions: Fibrous Hyperplasia on Oral Mucosa

Treatments: Procedure: Excisional biopsy with scalpel; Procedure: Excisional biopsy with Er:YAG laser; Procedure: Excisional biopsy with CO2 laser

Study type: Interventional

Funder types: Other

Identifiers

NCT03001791

271-13

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Clinical tentative diagnosis of fibrous hyperplasia in the buccal mucosa
• Fibrous hyperplasia dimensions 0.5 to 2 cm
• Patient understands and reads the German language
• Written informed consent

Exclusion criteria

• Untreated diabetes Typ II
• Severe infectious disease (HIV, hepatitis)
• Severe psychiatric disease
• Immunosuppressive therapy
• Anticoagulation
• Pregnancy; a pregnancy test (Clearblue®) is performed in women of childbearing age

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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75 participants in 3 patient groups

Er:YAG laser

Experimental group

Description:

Excisional biopsy of fibrous hyperplasia 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.

Treatment:

Procedure: Excisional biopsy with Er:YAG laser

CO2 laser

Experimental group

Description:

Excisional biopsy of fibrous hyperplasia 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.

Treatment:

Procedure: Excisional biopsy with CO2 laser

Scalpel

Experimental group

Description:

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

Treatment:

Procedure: Excisional biopsy with scalpel