Oral Biopsies: Evaluation of the Post-surgical Discomfort

Completed

• Conditions: Biopsy Wound; Quality of Life; Surgical Wound; Healing Surgical Wounds
• Interventions: Other: OHIP-14 Administration; Other: VNS Administration

• Registration Number: NCT04514263
• Lead Sponsor: Catholic University of the Sacred Heart

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-08
• Primary Completion: 2019-03-08
• Study Completion: 2019-12-08
• Status Verified: 2020-08
• Study First Submitted: 2020-08-06
• Study First Submitted QC: 2020-08-13
• Last Update Submitted: 2020-08-13
• Study First Posted: 2020-08-14
• Last Update Posted: 2020-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• no systemic or local contraindications for surgical treatment
• need for an oral biopsy (both excisional and incisional).

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Oral Biopsy	VNS Administration	Patients with oral lesions undergoing diagnostic or therapeutic biopsies either for benign lesions or potentially malignant disorders or malignant lesions or salivary glands diseases.
Oral Biopsy	OHIP-14 Administration	Patients with oral lesions undergoing diagnostic or therapeutic biopsies either for benign lesions or potentially malignant disorders or malignant lesions or salivary glands diseases.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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	Three weeks after an oral biopsy	To evaluate which clinical variable (systemic or local) can modify the wound healing or the patient perception.

Trial Locations

Locations (1)

Catholic University of the Sacred Heart; 🇮🇹 Rome, Italy