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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 below

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

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 more

Secondary 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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

McGill UniversityLead Sponsor

394 Previous Clinical Trials

998,341 Total Patients Enrolled

Belinda Nicolau, DDS, PhDPrincipal InvestigatorMcGill University

Media Library

Carrageenan Mouthwash (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05746988 — N/A

Human Papillomavirus Research Study Groups: Carrageenan-based Mouthwash, Placebo Mouthwash

Human Papillomavirus Clinical Trial 2023: Carrageenan Mouthwash Highlights & Side Effects. Trial Name: NCT05746988 — N/A

Carrageenan Mouthwash (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05746988 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged 85 and above qualified to partake in this clinical trial?

"This investigation mandates that enrolled patients are aged 18 to 45. There exists 222 clinical trials for minors and 642 studies available for participants over 65 years old."

Answered by AI

Are there any openings remaining in this clinical trial?

"According to current clinicaltrials.gov listings, this particular trial is not open for patient recruitment at the moment; its first posting was on February 1st 2023 and it has been recently updated as of February 16th 2023. Despite being closed off to new patients, 847 other trials are searching for enrollees right now."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Carrageenan for the Prevention of Oral HPV Infection

Dr. Belinda Nicolau 2023. "Carrageenan for the Prevention of Oral HPV Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05746988.