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

NCT ID: NCT03001791

Last Updated: 2017-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2017-08-10

Brief Summary

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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

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Conditions

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Fibrous Hyperplasia on Oral Mucosa

Keywords

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CO2 laser thermal damage zone Er:YAG laser

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Excisional biopsy with Er:YAG laser

Intervention Type PROCEDURE

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.

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.

Group Type EXPERIMENTAL

Excisional biopsy with CO2 laser

Intervention Type PROCEDURE

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.

Scalpel

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

Group Type EXPERIMENTAL

Excisional biopsy with scalpel

Intervention Type PROCEDURE

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).

Interventions

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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.

Intervention Type 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.

Intervention Type 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).

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Bern

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Valerie GA Suter, Dr med dent

Role: PRINCIPAL_INVESTIGATOR

Department of Oral Surgery and Stomatology, Dental School, University of Bern

Locations

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

Bern, , Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type DERIVED
PMID: 31230766 (View on PubMed)

Other Identifiers

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271-13

Identifier Type: -

Identifier Source: org_study_id