Oral Biopsies: Evaluation of the Post-surgical Discomfort
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Oral Biopsy 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
All patients fulfilled the OHIP-14 questionnaire three times: six hours, seven days and twenty-one days after the biopsy
Other: VNS Administration
All patients fulfilled the VNS scale three times: six hours, seven days and twenty-one days after the biopsy
|
Outcome Measures
Primary Outcome Measures
- Correlation between the clinical healing and patient perception [Six hours after an oral biopsy]
To evaluate whether the clinical evaluation of a wound healing shows a correspondence with the patient perception of the same process.
- Correlation between the clinical healing and patient perception [One week after an oral biopsy]
To evaluate whether the clinical evaluation of a wound healing shows a correspondence with the patient perception of the same process.
- Correlation between the clinical healing and patient perception [Three weeks after an oral biopsy]
To evaluate whether the clinical evaluation of a wound healing shows a correspondence with the patient perception of the same process.
Secondary Outcome Measures
- Correlation between OHIP-14 and VNS scale [Six hours after an oral biopsy]
Correlation between two different tools evaluating patient perception
- Correlation between OHIP-14 and VNS scale [One week after an oral biopsy]
Correlation between two different tools evaluating patient perception
- Correlation between OHIP-14 and VNS scale [Three weeks after an oral biopsy]
Correlation between two different tools evaluating patient perception
- Clinical variables which influence the healing and patient perception [Six hours after an oral biopsy]
To evaluate which clinical variable (systemic or local) can modify the wound healing or the patient perception.
- Clinical variables which influence the healing and patient perception [One week after an oral biopsy]
To evaluate which clinical variable (systemic or local) can modify the wound healing or the patient perception.
- Clinical variables which influence the healing and patient perception [Three weeks after an oral biopsy]
To evaluate which clinical variable (systemic or local) can modify the wound healing or the patient perception.
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Catholic University of the Sacred Heart | Rome | Italy | 00168 |
Sponsors and Collaborators
- Catholic University of the Sacred Heart
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OHIP-OB