Oral Biopsies: Evaluation of the Post-surgical Discomfort

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

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.

Study Overview

• Status: Completed
• Conditions: Quality of Life; Surgical Wound; Biopsy Wound; Healing Surgical Wounds
• Intervention / Treatment: Other: OHIP-14 Administration; Other: VNS Administration

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• Italy
  • Rome, Italy, 00168
    • Catholic University of the Sacred Heart

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Eighty-four patients were enrolled in this study; four of them were excluded because the clinical records were incomplete. Among the 80 patients left, 30 were males and 50 females, with a mean age of 60.25 years (range 23-88); clinical data about remote pathological history were collected: 31/80 patients did not have any systemic diseases, 22/80 only one disease, 27/80 more than one disease; 36/80 patients did not take any drug, 16/80 only one and 28/80 more than one; 63/80 patients did not smoke, 10/80 were former smokers and 7/80 were smokers.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

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

Collaborators and Investigators

• Sponsor: Catholic University of the Sacred Heart

Study record dates

Study Major Dates

• Study Start (Actual): January 8, 2018
• Primary Completion (Actual): March 8, 2019
• Study Completion (Actual): December 8, 2019

Study Registration Dates

• First Submitted: August 6, 2020
• First Submitted That Met QC Criteria: August 13, 2020
• First Posted (Actual): August 14, 2020

Study Record Updates

• Last Update Posted (Actual): August 14, 2020
• Last Update Submitted That Met QC Criteria: August 13, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Surgical Wound
• Other Study ID Numbers: OHIP-OB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No