Oral Biopsies: Evaluation of the Post-surgical Discomfort

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04514263

Enrollment

Registered

2020-08-14

Start date

2018-01-08

Completion date

2019-12-08

Last updated

2020-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

OTHEROHIP-14 Administration

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

OTHERVNS Administration

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Correlation between the clinical healing and patient perception	Six hours 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

Measure	Time frame	Description
Correlation between OHIP-14 and VNS scale	Six hours after an oral biopsy	Correlation between two different tools evaluating patient perception
Clinical variables which influence the healing and patient perception	Six hours after an oral biopsy	To evaluate which clinical variable (systemic or local) can modify the wound healing or the patient perception.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026