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

Study Overview
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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.

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

Conditions
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Fibrous Hyperplasia on Oral Mucosa

Intervention / Treatment
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* Procedure: Excisional biopsy with Er:YAG laser
* Procedure: Excisional biopsy with CO2 laser
* Procedure: Excisional biopsy with scalpel


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Er:YAG laser<br>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<br>* 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.<br>|
| Experimental: CO2 laser<br>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<br>* 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.<br>|
| Experimental: Scalpel<br>Excisional biopsy of fibrous hyperplasia with scalpel (blade 15C). Polyamide sutures (Seralon 5-DS15, Serag Wiessner KG, Naila, Germany). | Procedure: Excisional biopsy with scalpel<br>* 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).<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CO2 laser, thermal damage zone, Er:YAG laser