Condition category
Oral Health
Date applied
03/04/2017
Date assigned
05/05/2017
Last edited
22/09/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
An oral biopsy (where a piece of tissue is removed in order to be analysed) may be done for patients with oral lesions (wounds or cuts) in order to figure out the cause of their lesions. This is can help diagnose different oral diseases. Oral biopsies are very common and are safe procedures. They usually consist of a small piece of the tongue, mouth or gum being removed for further analysis. They are usually quite painless procedures but they do require some healing time. Certain types of mouth wash with particular ingredients such as chlorhexidine (a disinfectant and antiseptic that reduces bacteria) could help participants heal faster, prevent pain and improve quality of life after the procedure. The aim of this study is to examine if using a chlorhexidine mouth-rinse after an oral biopsy could help patients heal faster.

Who can participate?
Adults aged 18 and older who require an oral biopsy for their history of oral lesions.

What does the study involve?
Participants undergo the standard oral biopsy procedure. They are then randomly allocated to one of three groups. Those in the first group are given a 0.12% clorhexidine mouth-rinse to take twice daily for six days (starting one day after the procedure). Those in the second group are given a 0.20% chlorhexidine mouth-rinse to take twice daily for six days (starting one day after the procedure). Those in the third group receive no treatment after their oral biopsy. Participants are followed up one week after the procedure to see how well they have healed, and to assess their pain levels and quality of life.

What are the possible benefits and risks of participating?
Participants may benefit from a quicker healing time after the oral biopsy. There are no notable risks with participating but participants are reminded to read the information sheets given by the medication.

Where is the study run from?
University of Turin (Italy)

When is the study starting and how long is it expected to run for?
April 2017 to November 2017

Who is funding the study?
Investigator initiated and funded (Italy)

Who is the main contact?
Dr Paolo G. Arduino
paologiacomo.arduino@unito.it

Trial website

Contact information

Type

Scientific

Primary contact

Prof Paolo Giacomo Arduino

ORCID ID

http://orcid.org/0000-0002-8798-7834

Contact details

Via Nizza 230
Turin
10100
Italy
00390116331522
paologiacomo.arduino@unito.it

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

DSarduino13

Study information

Scientific title

Clinical evaluation of the effect of two different chlorhexidine formulations in mouth-rinses on the immediate postoperative period for oral mucosal biopsies: A randomized, placebo-controlled trial

Acronym

Study hypothesis

The aim of this study is to evaluate the difference between of two different chlorhexidine formulations (012% vs 0.20%) in mouth-rinses on the immediate postoperative period for oral mucosal biopsies, and also comparing those results with patients who do not take any topical medication.

Ethics approval

A.O.U. Città della Salute e della Scienza di Torino, 07/12/2016, pots. n° 019198

Study design

Three armed randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Patients who need to perform an oral biopsy due to different oral conditions.

Intervention

After participants undergo the standard care for histological determination of oral lesions (oral biopsy), they are then randomly allocated to one of three groups. Allocation to the groups is performed using sequentially numbered randomization table. RANCODE (version 3.6) is used to generate the randomization sequence.

Group 1: Participants in this group are given 0.12% chlorhexidine mouth-rinse to take twice daily (10 mL) for six days to start the day after the oral biopsy.
Group 2: Participants in this group are given 0.20% chlorhexidine mouth-rinse to take twice daily (10 mL) for six days to start the day after the oral biopsy.
Group 3 (Control): Participants are given no treatment to take after the oral biopsy.

At the day of suture removal (after one week) participants are followed up for reported pain, quality of life, tissue healing are documented. The same surgeon who performed the oral biopsy conducts the follow up.

Intervention type

Drug

Phase

Not Specified

Drug names

Chlorhexidine

Primary outcome measures

1. Quality of life is detailed by the patients using the Italian version of the oral health related quality of life questionnaire measured by the Oral Health Impact Profile-14 (OHIP-14) at day six
2. Post-operative pain is detailed by the patients using a Visual Analogue Scale (VAS) at baseline, day one, three, and six

Secondary outcome measures

1. Early post-operative complications are detailed during the clinical evaluation at day seven
2. Healing of biopsy site is measured during the clinical evaluation at day seven

Overall trial start date

01/04/2017

Overall trial end date

01/11/2017

Reason abandoned

Eligibility

Participant inclusion criteria

1. Consecutive caucasian patients, attending the Oral Medicine Section of the Department of Surgical Sciences, Turin Hospital
2. Patients are those normally referred for histological determination of oral lesions
3. Adults aged 18 and older

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant exclusion criteria

1. Clinically significant medical history (e.g. systemic infective disease, heart and vascular disease, liver disease, haematological disease, deficiency of the coagulation, diabetes and neoplastic disease)
2. Immunosuppressed or immunocompromised or those who received radiotherapy to the head and neck area
3. Already under antibiotic treatment for any other reasons or treated or under treatment with intravenous amino-bisphosphonates
4. Pregnant or lactating females; patients with incapacity to understand verbal and written instructions

Recruitment start date

01/05/2017

Recruitment end date

01/09/2017

Locations

Countries of recruitment

Italy

Trial participating centre

University of Turin
CIR Dental School Via Nizza 230
Turin
10100
Italy

Sponsor information

Organisation

University of Turin

Sponsor details

CIR Dental School
Via Nizza 230
Turin
10100
Italy
00390116331522
paologiacomo.arduino@unito.it

Sponsor type

University/education

Website

www.patologiaoraletorino.it

Funders

Funder type

Industry

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a peer reviewed journal.

IPD sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr. Paolo G. Arduino at paologiacomo.arduino@unito.it

Intention to publish date

01/12/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

22/09/2017: Ethics approval details added.