Efficacy of chlorhexidine in the first week after an oral biopsy
| ISRCTN | ISRCTN14440167 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14440167 |
| Secondary identifying numbers | DSarduino13 |
- Submission date
- 03/04/2017
- Registration date
- 05/05/2017
- Last edited
- 09/04/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
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
Contact information
Scientific
Via Nizza 230
Turin
10100
Italy
 ORCID ID |
0000-0002-8798-7834 |
|---|---|
| Phone | 00390116331522 |
| paologiacomo.arduino@unito.it |
Study information
| Study design | Three armed randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| 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(s) | A.O.U. Città della Salute e della Scienza di Torino, 07/12/2016, pots. n° 019198 |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Chlorhexidine |
| Primary outcome measure | 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 study start date | 01/04/2017 |
| Overall study end date | 01/11/2017 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 300 |
| Total final enrolment | 354 |
| 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 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
Study participating centre
Via Nizza 230
Turin
10100
Italy
Sponsor information
University/education
CIR Dental School
Via Nizza 230
Turin
10100
Italy
| Phone | 00390116331522 |
|---|---|
| paologiacomo.arduino@unito.it | |
| Website | www.patologiaoraletorino.it |
"ROR" |
https://ror.org/048tbm396 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/12/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 28/03/2020 | 09/04/2020 | Yes | No |
Editorial Notes
09/04/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
22/09/2017: Ethics approval details added.
