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Trial Title:
Carrageenan for the Prevention of Oral HPV Infection
NCT ID:
NCT05746988
Condition:
Human Papilloma Virus
Conditions: Official terms:
Infections
Papillomavirus Infections
Papilloma
Conditions: Keywords:
Oral HPV infection
Mouthwash
Carrageenan
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
Triple (Participant, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Other
Intervention name:
Mouthwash gargling
Description:
15 - 20 ml of mouthwash to be gargled vigorously for 30 to 60 seconds daily (morning and
night) as an adjunct to regular toothbrushing, and before and/or immediately after sexual
activities.
Arm group label:
Carrageenan-based Mouthwash
Arm group label:
Placebo Mouthwash
Summary:
This is a placebo-controlled, triple-blind randomized clinical trial (RCT) designed to
evaluate the feasibility of conducting a larger multicentric RCT investigating the effect
of a Carrageenan mouthwash on oral HPV infection. Eligible participants will complete a
single in-person visit at baseline, filling out a questionnaire on their electronic
device and giving an oral rinse sample for HPV testing. They will receive an adequate
supply of mouthwash and instructions on its use. They will subsequently be followed up
for up to six months. Every two weeks, participants will fill out a follow-up
questionnaire on mouthwash use and sexual activities and self-collect oral rinse sample
to be returned by mail.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Aged between 18 and 45 years old
- Sexually active and have had oral sex in the past month
- Will be residing in Montreal for the next six (6) months after study enrolment
Exclusion Criteria:
- Previous vaccination against HPV
- Previous cancer of the mouth or throat
Gender:
All
Minimum age:
18 Years
Maximum age:
45 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
McGill University
Address:
City:
Montreal
Zip:
H3G 1Y6
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Belinda Nicolau, PhD
Phone:
1-514-398-7203
Phone ext:
09465
Email:
belinda.nicolau@mcgill.ca
Contact backup:
Last name:
Babatunde Alli, BDS, MSc
Email:
babatunde.alli@mcgill.ca
Investigator:
Last name:
Belinda Nicolau, PhD
Email:
Principal Investigator
Start date:
May 26, 2023
Completion date:
March 2024
Lead sponsor:
Agency:
McGill University
Agency class:
Other
Source:
McGill University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05746988
