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

Not Applicable

Completed

• Conditions: Fibrous Hyperplasia on Oral Mucosa
• Interventions: Procedure: Excisional biopsy with CO2 laser; Procedure: Excisional biopsy with scalpel

• Registration Number: NCT03001791
• Lead Sponsor: University of Bern

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2016-11-14
• Study First Submitted QC: 2016-12-20
• Study First Posted: 2016-12-23
• Primary Completion: 2017-07-04
• Study Completion: 2017-08-10
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-24
• Last Update Posted: 2017-11-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 75

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CO2 laser	Excisional biopsy with CO2 laser	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.
Scalpel	Excisional biopsy with scalpel	Excisional biopsy of fibrous hyperplasia with scalpel (blade 15C). Polyamide sutures (Seralon 5-DS15, Serag Wiessner KG, Naila, Germany).

Primary Outcome Measures

Name	Time	Method
Histopathological thermal damage zone	Three months	Biopsy specimens fixed in a 4% neutral-buffered formalin solution, embedded in paraffin, sectioned in slices of 5 μm, and stained with hematoxylin-eosin.; Measurements of the thermal damage zone (in μm) on histopathological specimens by pathologist, blinded to the surgical method used. Measurements of the maximal and the minimal thermal damage zone on a representative section on both lateral edges of the fibrous hyperplasia.

Secondary Outcome Measures

Name	Time	Method
Number of patients with other postoperative effects	Two weeks	Number of patients with other postoperative events (e.g. swelling, bleeding) on the same study form
Time of surgery	15 minutes	Registration of time of intervention with a stopwatch. It starts when the laser beam is first applied and ends when the wound paste had been applied.
Postoperative Pain	Two weeks	Registration of pain on VAS scale (ranging 0-100) during 14 days. The first VAS value was filled in before surgery, the second value in the evening after surgery and then on each of the following days on a study form handed out to patient.; Intake of Analgesic (type, dose) are also filled in by patient on the study form i a specific section.
Bleeding during surgery	15 minutes	Registration of bleeding events (yes/no) and method to stop the bleeding during surgery (electrocautery, sutures)

Trial Locations

Locations (1)

Department of oral Surgery and Stomatology, Dental school, University Bern; 🇨🇭 Bern, Switzerland