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Clinical Trials/NCT04514263
NCT04514263
Completed
N/A

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

Catholic University of the Sacred Heart1 site in 1 country80 target enrollmentJanuary 8, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Quality of Life
Sponsor
Catholic University of the Sacred Heart
Enrollment
80
Locations
1
Primary Endpoint
Correlation between the clinical healing and patient perception
Status
Completed
Last Updated
5 years ago

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.

Registry
clinicaltrials.gov
Start Date
January 8, 2018
End Date
December 8, 2019
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Carlo Lajolo

Associate Professor

Catholic University of the Sacred Heart

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

Outcomes

Primary Outcomes

Correlation between the clinical healing and patient perception

Time Frame: 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 Outcomes

  • Correlation between OHIP-14 and VNS scale(Three weeks after an oral biopsy)
  • Clinical variables which influence the healing and patient perception(Three weeks after an oral biopsy)

Study Sites (1)

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