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Carrageenan Mouthwash for Oral HPV Prevention
N/A
Recruiting
Led By Belinda Nicolau, DDS, PhD
Research Sponsored by McGill University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged between 18 and 45 years old
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will study if a certain mouthwash can help prevent HPV in the mouth. People will visit once, get the mouthwash and answer questions over 6 months. They'll also take mouthwash samples to mail back.
Who is the study for?
This trial is for individuals aged 18-45 living in Montreal who plan to stay there for the next six months. Participants should be sexually active, having had oral sex recently, and not vaccinated against HPV or have had mouth/throat cancer.Check my eligibility
What is being tested?
The study tests if gargling with a Carrageenan mouthwash can prevent oral HPV infection compared to a placebo. It's a triple-blind RCT where participants use the mouthwash and provide samples every two weeks for up to six months.See study design
What are the potential side effects?
Since this trial involves using a mouthwash, potential side effects may include mild reactions like taste changes or irritation in the mouth. However, specific side effects of Carrageenan are not detailed here.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 45 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acceptability of study procedures as assessed by satisfaction on a Visual Analog Scale
Adherence rate for mouthwash use
Adherence rate for self-sampling
+2 moreSecondary outcome measures
Mouthwash safety (Pain score) as assessed by the Visual Analog Scale
Other outcome measures
Time to oral HPV clearance
Time to oral HPV infection
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Carrageenan-based MouthwashExperimental Treatment1 Intervention
Mouthwash with Carrageenan as an active ingredient
Group II: Placebo MouthwashPlacebo Group1 Intervention
Mouthwash without Carrageenan but similar in colour, taste, and "mouthfeel" to the experimental mouthwash
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Who is running the clinical trial?
McGill UniversityLead Sponsor
399 Previous Clinical Trials
1,000,248 Total Patients Enrolled
Belinda Nicolau, DDS, PhDPrincipal InvestigatorMcGill University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been sexually active and engaged in oral sex recently.I have been vaccinated against HPV.I have had cancer in my mouth or throat before.I am between 18 and 45 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Carrageenan-based Mouthwash
- Group 2: Placebo Mouthwash
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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