Fibrous Hyperplasia on Oral Mucosa Clinical Trial
Official title:
Clinical and Histopathological Comparison of ER:YAG Laser, CO2 Laser and Scalpel Excision of Fibrous Hyperplasia on the Buccal Mucosa
| Verified date | November 2017 |
| Source | University of Bern |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 75 |
| Est. completion date | August 10, 2017 |
| Est. primary completion date | July 4, 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Switzerland | Department of oral Surgery and Stomatology, Dental school, University Bern | Bern |
| Lead Sponsor | Collaborator |
|---|---|
| University of Bern |
Switzerland,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Bleeding during surgery | Registration of bleeding events (yes/no) and method to stop the bleeding during surgery (electrocautery, sutures) | 15 minutes |