Skip to main content
OpenTrials
Completed

NCT Number: NCT04514263

Oral Biopsies: Evaluation of the Post-surgical Discomfort

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Catholic University of the Sacred Heart

Rome, 00168, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OHIP-14 Administration

Other

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

VNS Administration

Other

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

Primary outcomes

  1. Correlation between the clinical healing and patient perception

    Time frame: 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.

  2. Correlation between the clinical healing and patient perception

    Time frame: One week 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.

  3. Correlation between the clinical healing and patient perception

    Time frame: 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 outcomes

  1. Correlation between OHIP-14 and VNS scale

    Time frame: Six hours after an oral biopsy

    Correlation between two different tools evaluating patient perception

  2. Correlation between OHIP-14 and VNS scale

    Time frame: One week after an oral biopsy

    Correlation between two different tools evaluating patient perception

  3. Correlation between OHIP-14 and VNS scale

    Time frame: Three weeks after an oral biopsy

    Correlation between two different tools evaluating patient perception

  4. Clinical variables which influence the healing and patient perception

    Time frame: Six hours after an oral biopsy

    To evaluate which clinical variable (systemic or local) can modify the wound healing or the patient perception.

  5. Clinical variables which influence the healing and patient perception

    Time frame: One week after an oral biopsy

    To evaluate which clinical variable (systemic or local) can modify the wound healing or the patient perception.

  6. Clinical variables which influence the healing and patient perception

    Time frame: Three weeks after an oral biopsy

    To evaluate which clinical variable (systemic or local) can modify the wound healing or the patient perception.

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 14, 2020
Registry last updated
Aug 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.