Oral Biopsies: Evaluation of the Post-surgical Discomfort

Study Overview
=================
Brief Summary
-----------------
Aim of this study is to evaluate the post-operative course in patients undergoing diagnostic or therapeutic oral mucosal biopsies. To evaluate the wound healing, all variables connected with the surgery (including post-operative complications) were recorded. To evaluate the psychological and behavioral impact of the post-operative discomfort, two survey tools were administered: OHIP-14 and visual number scale of pain (VNS) were administered at 6h, 7 days and 21 days after biopsy.

Official Title
-----------------
Evaluation of the Post-surgical Discomfort in Patients Undergoing Diagnostic Oral Biopsies

Conditions
-----------------
Quality of Life, Biopsy Wound, Surgical Wound, Healing Surgical Wounds

Intervention / Treatment
-----------------
* Other: OHIP-14 Administration
* Other: VNS Administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: no systemic or local contraindications for surgical treatment need for an oral biopsy (both excisional and incisional). Exclusion Criteria: Since no absolute contraindications to oral biopsies are reported, no exclusion criteria were selected for this study, but if any relative contraindication was present (i.e. bleeding disorders) biopsy was performed after the resolution of the problem

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Oral Biopsy<br>Patients with oral lesions undergoing diagnostic or therapeutic biopsies either for benign lesions or potentially malignant disorders or malignant lesions or salivary glands diseases. | Other: OHIP-14 Administration<br>* All patients fulfilled the OHIP-14 questionnaire three times: six hours, seven days and twenty-one days after the biopsy<br>Other: VNS Administration<br>* All patients fulfilled the VNS scale three times: six hours, seven days and twenty-one days after the biopsy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between the clinical healing and patient perception | To evaluate whether the clinical evaluation of a wound healing shows a correspondence with the patient perception of the same process. | Six hours after an oral biopsy | 
| Correlation between the clinical healing and patient perception | To evaluate whether the clinical evaluation of a wound healing shows a correspondence with the patient perception of the same process. | One week after an oral biopsy | 
| Correlation between the clinical healing and patient perception | To evaluate whether the clinical evaluation of a wound healing shows a correspondence with the patient perception of the same process. | Three weeks after an oral biopsy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between OHIP-14 and VNS scale | Correlation between two different tools evaluating patient perception | Six hours after an oral biopsy | 
| Correlation between OHIP-14 and VNS scale | Correlation between two different tools evaluating patient perception | One week after an oral biopsy | 
| Correlation between OHIP-14 and VNS scale | Correlation between two different tools evaluating patient perception | Three weeks after an oral biopsy | 
| Clinical variables which influence the healing and patient perception | To evaluate which clinical variable (systemic or local) can modify the wound healing or the patient perception. | Six hours after an oral biopsy | 
| Clinical variables which influence the healing and patient perception | To evaluate which clinical variable (systemic or local) can modify the wound healing or the patient perception. | One week after an oral biopsy | 
| Clinical variables which influence the healing and patient perception | To evaluate which clinical variable (systemic or local) can modify the wound healing or the patient perception. | Three weeks after an oral biopsy |