Oral Biopsies: Evaluation of the Post-surgical Discomfort

NCT04514263 | Completed

• 1 other identifier: OHIP-OB
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Correlation between OHIP-14 and VNS scale

  Six hours after an oral biopsy

• Correlation between OHIP-14 and VNS scale

  One week after an oral biopsy

• Correlation between OHIP-14 and VNS scale

  Three weeks after an oral biopsy

• Clinical variables which influence the healing and patient perception

  Six hours after an oral biopsy

• Clinical variables which influence the healing and patient perception

  One week after an oral biopsy

Study Arms (1)

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; Other: VNS Administration

Interventions

OHIP-14 Administration OTHER

All patients fulfilled the OHIP-14 questionnaire three times: six hours, seven days and twenty-one days after the biopsy

Oral Biopsy

VNS Administration OTHER

All patients fulfilled the VNS scale three times: six hours, seven days and twenty-one days after the biopsy

Oral Biopsy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Catholic University of the Sacred Heart

Rome, 00168, Italy

Location

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 6, 2020
• First Posted: August 14, 2020
• Study Start: January 8, 2018
• Primary Completion: March 8, 2019
• Study Completion: December 8, 2019
• Last Updated: August 14, 2020

Record last verified: 2020-08

Locations

IT (1)