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Completed

NCT Number: NCT03001791

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.

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Key information

Conditions

Fibrous Hyperplasia on Oral Mucosa

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Bern, 3010, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Excisional biopsy with Er:YAG laser

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.

Excisional biopsy with CO2 laser

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.

Excisional biopsy with scalpel

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).

Primary outcomes

  1. Histopathological thermal damage zone

    Time frame: 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 outcomes

  1. Postoperative Pain

    Time frame: 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.

  2. Number of patients with other postoperative effects

    Time frame: Two weeks

    Number of patients with other postoperative events (e.g. swelling, bleeding) on the same study form

  3. Time of surgery

    Time frame: 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.

  4. Bleeding during surgery

    Time frame: 15 minutes

    Registration of bleeding events (yes/no) and method to stop the bleeding during surgery (electrocautery, sutures)

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Dec 23, 2016
Registry last updated
Nov 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.