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

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

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.

Study Overview

• Status: Completed
• Conditions: Fibrous Hyperplasia on Oral Mucosa
• Intervention / Treatment: Procedure: Excisional biopsy with Er:YAG laser; Procedure: Excisional biopsy with CO2 laser; Procedure: Excisional biopsy with scalpel

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Bern, Switzerland, 3010
    • Department of oral Surgery and Stomatology, Dental school, University Bern

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Er:YAG laser; 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.	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.
Experimental: 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.	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.
Experimental: Scalpel; Excisional biopsy of fibrous hyperplasia with scalpel (blade 15C). Polyamide sutures (Seralon 5-DS15, Serag Wiessner KG, Naila, Germany).	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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histopathological thermal damage zone	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.	Three months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain	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.	Two weeks
Number of patients with other postoperative effects	Number of patients with other postoperative events (e.g. swelling, bleeding) on the same study form	Two weeks
Time of surgery	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.	15 minutes
Bleeding during surgery	Registration of bleeding events (yes/no) and method to stop the bleeding during surgery (electrocautery, sutures)	15 minutes

Collaborators and Investigators

• Sponsor: University of Bern
• Investigators: Principal Investigator: Valerie GA Suter, Dr med dent, Department of Oral Surgery and Stomatology, Dental School, University of Bern

Publications and helpful links

General Publications

• Suter VGA, Altermatt HJ, Bornstein MM. A randomized controlled trial comparing surgical excisional biopsies using CO2 laser, Er:YAG laser and scalpel. Int J Oral Maxillofac Surg. 2020 Jan;49(1):99-106. doi: 10.1016/j.ijom.2019.05.012. Epub 2019 Jun 21.

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): July 4, 2017
• Study Completion (Actual): August 10, 2017

Study Registration Dates

• First Submitted: November 14, 2016
• First Submitted That Met QC Criteria: December 20, 2016
• First Posted (Estimate): December 23, 2016

Study Record Updates

• Last Update Posted (Actual): November 27, 2017
• Last Update Submitted That Met QC Criteria: November 24, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Keywords: CO2 laser; thermal damage zone; Er:YAG laser
• Additional Relevant MeSH Terms: Pathologic Processes; Hyperplasia
• Other Study ID Numbers: 271-13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No