Oral Biopsies: Evaluation of the Post-surgical Discomfort

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04514263
• Other study ID #: OHIP-OB
• Status: Completed
• Start date: January 8, 2018
• Est. completion date: December 8, 2019

Study information

• Verified date: August 2020
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: December 8, 2019
• Est. primary completion date: March 8, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biopsy Wound
• Healing Surgical Wounds
• Quality of Life
• Surgical Wound
• Wounds and Injuries

Intervention

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

Locations

Country	Name	City	State
Italy	Catholic University of the Sacred Heart	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Correlation between OHIP-14 and VNS scale	Correlation between two different tools evaluating patient perception	Six hours after an oral biopsy
Secondary	Correlation between OHIP-14 and VNS scale	Correlation between two different tools evaluating patient perception	One week after an oral biopsy
Secondary	Correlation between OHIP-14 and VNS scale	Correlation between two different tools evaluating patient perception	Three weeks after an oral biopsy
Secondary	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
Secondary	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
Secondary	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