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Carrageenan for the Prevention of Oral HPV Infection

Primary Purpose

Human Papilloma Virus

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Mouthwash gargling
Sponsored by
McGill University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Human Papilloma Virus focused on measuring Oral HPV infection, Mouthwash, Carrageenan

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • McGill UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Carrageenan-based Mouthwash

Placebo Mouthwash

Arm Description

Mouthwash with Carrageenan as an active ingredient

Mouthwash without Carrageenan but similar in colour, taste, and "mouthfeel" to the experimental mouthwash

Outcomes

Primary Outcome Measures

Recruitment rate
This will be measured by the total number of participants recruited into the study. The investigators intend to recruit 40 participants. Recruitment rate will be calculated as number of participants per month.
Drop-out rate
The proportion of individuals who enrolled into the study but left before the end of the study will be documented.
Adherence rate for mouthwash use
This will be calculated as the proportion of participants who completed the study and complied with the mouthwash use regimen.
Adherence rate for self-sampling
This will be calculated as the proportion of participants who completed the study and complied with the bi-weekly self-sampling procedure
Acceptability of study procedures as assessed by satisfaction on a Visual Analog Scale
Qualitative and quantitative assessment will be used to evaluate participants' experience with the RCT through the follow-up questionnaire and an exit question. Participants will be asked to rate their satisfaction with the study procedure on a scale of 1-10 (10 being the highest satisfaction level). This will focus on level of satisfaction of the participants with mouthwash use around sexual activities and the level of satisfaction of the participants with the biweekly self-sampling.

Secondary Outcome Measures

Mouthwash safety (Pain score) as assessed by the Visual Analog Scale
The mean pain score (for any pain ascribed to the mouthwash e.g., burning mouth, recurrent aphthous stomatitis e.t.c.) measured on the VAS (1-10; 10 being the worst pain) will be recorded.

Full Information

First Posted
January 17, 2023
Last Updated
June 19, 2023
Sponsor
McGill University
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1. Study Identification

Unique Protocol Identification Number
NCT05746988
Brief Title
Carrageenan for the Prevention of Oral HPV Infection
Official Title
Carrageenan for the Prevention of Oral HPV Infection: a Feasibility, Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 26, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
McGill University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papilloma Virus
Keywords
Oral HPV infection, Mouthwash, Carrageenan

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Carrageenan-based Mouthwash
Arm Type
Experimental
Arm Description
Mouthwash with Carrageenan as an active ingredient
Arm Title
Placebo Mouthwash
Arm Type
Placebo Comparator
Arm Description
Mouthwash without Carrageenan but similar in colour, taste, and "mouthfeel" to the experimental mouthwash
Intervention Type
Other
Intervention Name(s)
Mouthwash gargling
Intervention 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.
Primary Outcome Measure Information:
Title
Recruitment rate
Description
This will be measured by the total number of participants recruited into the study. The investigators intend to recruit 40 participants. Recruitment rate will be calculated as number of participants per month.
Time Frame
1 year
Title
Drop-out rate
Description
The proportion of individuals who enrolled into the study but left before the end of the study will be documented.
Time Frame
1 year
Title
Adherence rate for mouthwash use
Description
This will be calculated as the proportion of participants who completed the study and complied with the mouthwash use regimen.
Time Frame
6 months
Title
Adherence rate for self-sampling
Description
This will be calculated as the proportion of participants who completed the study and complied with the bi-weekly self-sampling procedure
Time Frame
6 month
Title
Acceptability of study procedures as assessed by satisfaction on a Visual Analog Scale
Description
Qualitative and quantitative assessment will be used to evaluate participants' experience with the RCT through the follow-up questionnaire and an exit question. Participants will be asked to rate their satisfaction with the study procedure on a scale of 1-10 (10 being the highest satisfaction level). This will focus on level of satisfaction of the participants with mouthwash use around sexual activities and the level of satisfaction of the participants with the biweekly self-sampling.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Mouthwash safety (Pain score) as assessed by the Visual Analog Scale
Description
The mean pain score (for any pain ascribed to the mouthwash e.g., burning mouth, recurrent aphthous stomatitis e.t.c.) measured on the VAS (1-10; 10 being the worst pain) will be recorded.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Time to oral HPV infection
Description
Time to type-specific oral HPV infection will be recorded for participants with negative type-specific oral HPV status at baseline
Time Frame
6 months
Title
Time to oral HPV clearance
Description
Time to type-specific oral HPV clearance will be recorded for participants with positive type-specific oral HPV status at baseline
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Belinda Nicolau, DDS, PhD
Phone
1-514-398-7203
Ext
09465
Email
belinda.nicolau@mcgill.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Belinda Nicolau, DDS, PhD
Organizational Affiliation
McGill University
Official's Role
Principal Investigator
Facility Information:
Facility Name
McGill University
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1Y6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Belinda Nicolau, PhD
Phone
1-514-398-7203
Ext
09465
Email
belinda.nicolau@mcgill.ca
First Name & Middle Initial & Last Name & Degree
Babatunde Alli, BDS, MSc
Email
babatunde.alli@mcgill.ca
First Name & Middle Initial & Last Name & Degree
Belinda Nicolau, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Carrageenan for the Prevention of Oral HPV Infection

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