Carrageenan for the Prevention of Oral HPV Infection

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-26

Study Completion Date

2024-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Human Papilloma Virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Carrageenan-based Mouthwash

Mouthwash with Carrageenan as an active ingredient

Group Type EXPERIMENTAL

Mouthwash gargling

Intervention Type OTHER

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.

Placebo Mouthwash

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

Group Type PLACEBO_COMPARATOR

Mouthwash gargling

Intervention Type OTHER

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.

Interventions

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Mouthwash gargling

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.

Intervention Type OTHER

Eligibility Criteria

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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