Oral Biopsies: Evaluation of the Post-surgical Discomfort

Catholic University of the Sacred Heart

Status: Completed

Conditions: Healing Surgical Wounds; Surgical Wound; Quality of Life; Biopsy Wound

Treatments: Other: OHIP-14 Administration; Other: VNS Administration

Study type: Observational

Funder types: Other

Identifiers

NCT04514263

OHIP-OB

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

80 participants in 1 patient group

Oral Biopsy

Description:

Patients with oral lesions undergoing diagnostic or therapeutic biopsies either for benign lesions or potentially malignant disorders or malignant lesions or salivary glands diseases.

Treatment:

Other: VNS Administration

Other: OHIP-14 Administration