NCT05746988

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 28, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

May 26, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2024

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

6 months

First QC Date

January 17, 2023

Last Update Submit

June 19, 2023

Conditions

Human Papilloma Virus

Keywords

Oral HPV infectionMouthwashCarrageenan

Outcome Measures

Primary Outcomes (5)

  • 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.

    1 year

  • Drop-out rate

    The proportion of individuals who enrolled into the study but left before the end of the study will be documented.

    1 year

  • 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.

    6 months

  • 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

    6 month

  • 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.

    6 months

Secondary Outcomes (1)

  • Mouthwash safety (Pain score) as assessed by the Visual Analog Scale

    6 months

Other Outcomes (2)

  • Time to oral HPV infection

    6 months

  • Time to oral HPV clearance

    6 months

Study Arms (2)

Carrageenan-based Mouthwash

EXPERIMENTAL

Mouthwash with Carrageenan as an active ingredient

Other: Mouthwash gargling

Placebo Mouthwash

PLACEBO COMPARATOR

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

Other: Mouthwash gargling

Interventions

Mouthwash garglingOTHER

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.

Carrageenan-based MouthwashPlacebo Mouthwash

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Previous vaccination against HPV
  • Previous cancer of the mouth or throat

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

McGill University

Montreal, Quebec, H3G 1Y6, Canada

RECRUITING

Related Publications (1)

  • Alli BY, Madathil S, Tran SD, Nicolau B. Protocol: carrageenan for the prevention of oral HPV infection - a feasibility randomised clinical trial. BMJ Open. 2023 Jul 27;13(7):e074498. doi: 10.1136/bmjopen-2023-074498.

    PMID: 37500273DERIVED

Study Officials

  • Belinda Nicolau, DDS, PhD

    McGill University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Belinda Nicolau, DDS, PhD

CONTACT

1-514-398-7203belinda.nicolau@mcgill.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 17, 2023

First Posted

February 28, 2023

Study Start

May 26, 2023

Primary Completion

December 1, 2023

Study Completion

March 1, 2024

Last Updated

June 22, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)