Efficacy of chlorhexidine in the first week after an oral biopsy

• Register: ISRCTN
• Last refreshed on: 27 April 2020
• Main ID: ISRCTN14440167
• Date of registration: 05/05/2017
• Prospective Registration: No
• Primary sponsor: University of Turin
• Public title: Efficacy of chlorhexidine in the first week after an oral biopsy
• 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
• Date of first enrolment: 01/05/2017
• Target sample size: 300
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN14440167
• Study type: Interventional
• Study design: Three armed randomised controlled trial (Quality of life)
• Phase: Not Specified

Countries of recruitment

Italy

Contacts

• Name: Paolo Giacomo Arduino

Key inclusion & exclusion criteria

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

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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.

Primary Outcome(s)

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(s)

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

Secondary ID(s)

DSarduino13

Source(s) of Monetary Support

Investigator initiated and funded

Ethics review

Status:
Approval date:
Contact:

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

Results

• Results available: Yes
• Date Completed: 01/11/2017