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

Primary Purpose

Fibrous Hyperplasia on Oral Mucosa

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Excisional biopsy with Er:YAG laser
Excisional biopsy with CO2 laser
Excisional biopsy with scalpel
Sponsored by
University of Bern
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibrous Hyperplasia on Oral Mucosa focused on measuring CO2 laser, thermal damage zone, Er:YAG laser

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Er:YAG laser

CO2 laser

Scalpel

Arm 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.

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Number of patients with other postoperative effects
Number of patients with other postoperative events (e.g. swelling, bleeding) on the same study form
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.
Bleeding during surgery
Registration of bleeding events (yes/no) and method to stop the bleeding during surgery (electrocautery, sutures)

Full Information

First Posted
November 14, 2016
Last Updated
November 24, 2017
Sponsor
University of Bern
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1. Study Identification

Unique Protocol Identification Number
NCT03001791
Brief Title
Comparison of ER:YAG Laser, CO2 Laser and Scalpel Excision of Fibrous Hyperplasia on the Buccal Mucosa
Official Title
Clinical and Histopathological Comparison of ER:YAG Laser, CO2 Laser and Scalpel Excision of Fibrous Hyperplasia on the Buccal Mucosa
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
July 2013 (undefined)
Primary Completion Date
July 4, 2017 (Actual)
Study Completion Date
August 10, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Bern

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibrous Hyperplasia on Oral Mucosa
Keywords
CO2 laser, thermal damage zone, Er:YAG laser

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Er:YAG laser
Arm Type
Experimental
Arm 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.
Arm Title
CO2 laser
Arm Type
Experimental
Arm 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.
Arm Title
Scalpel
Arm Type
Experimental
Arm Description
Excisional biopsy of fibrous hyperplasia with scalpel (blade 15C). Polyamide sutures (Seralon 5-DS15, Serag Wiessner KG, Naila, Germany).
Intervention Type
Procedure
Intervention Name(s)
Excisional biopsy with Er:YAG laser
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Excisional biopsy with CO2 laser
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Excisional biopsy with scalpel
Intervention Description
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).
Primary Outcome Measure Information:
Title
Histopathological thermal damage zone
Description
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.
Time Frame
Three months
Secondary Outcome Measure Information:
Title
Postoperative Pain
Description
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.
Time Frame
Two weeks
Title
Number of patients with other postoperative effects
Description
Number of patients with other postoperative events (e.g. swelling, bleeding) on the same study form
Time Frame
Two weeks
Title
Time of surgery
Description
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.
Time Frame
15 minutes
Title
Bleeding during surgery
Description
Registration of bleeding events (yes/no) and method to stop the bleeding during surgery (electrocautery, sutures)
Time Frame
15 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valerie GA Suter, Dr med dent
Organizational Affiliation
Department of Oral Surgery and Stomatology, Dental School, University of Bern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of oral Surgery and Stomatology, Dental school, University Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
31230766
Citation
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.
Results Reference
derived

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

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