Chairside Mouthrinse Test and Cost Effectiveness (JuvePar)

November 2, 2020 updated by: Teija Raivisto, University of Helsinki

Pilot Study on Oral Health Status Chairside Mouthrinse Test in Finnish Adolescents and Cost Effectiveness of the Test

The aim is to study whether participants at risk could be identified using an aMMP-8 chairside mouth rinse test and to study if oral health and health behaviour is linked to the test result in Finnish adolescents.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Adolescents (14-15-year-olds) are randomly divided to control group and test group. Chairside mouth rinse test for aMMP-8 is performed for the test group. Two groups are compared with each other.

Participants are asked to fill a questionnaire which consists of questions concerning oral hygiene habits, tobacco products, alcohol, drug and snuff use.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Helsinki University
      • Helsinki, Helsinki University, Finland, FI-00014
        • Anna Maria Heikkinen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • All 8 class (aged 14-15 years) pupils in Jukola, Hämeenlinna, Finland
  • Written informed consent from the participants and their parents (one of them)

Exclusion Criteria:

  • No written consent to the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: aMMP-8 chairside test
Test group. The aMMP-8 chairside mouth rinse test is performed for the test group.It identifies adolescents with poor oral hygiene at risk for subclinical periodontitis without detectable and visible manifestations of the illness, such as periodontal deepened pockets.
Diagnostic test: aMMP-8 chairside test
No test
Other Names:
  • No test
No Intervention: No test
The other group is control group. No test administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
aMMP-8 test
Time Frame: 1 year
Mouth rinse samples are analysed by method for chair-side diagnostic testing: the aMMP-8 specific lateral-flow point-of-care (PoC)/chair-side test (PerioSafe®, Dentognostics GmbH, Jena, Germany). The result is provided in 5 minutes and is graded by eye as positive or negative. One line means that the test is negative but successfully done and two lines the test is positive.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Helsinki

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2017

Primary Completion (Anticipated)

November 2, 2020

Study Completion (Anticipated)

November 2, 2020

Study Registration Dates

First Submitted

October 7, 2019

First Submitted That Met QC Criteria

October 23, 2019

First Posted (Actual)

October 25, 2019

Study Record Updates

Last Update Posted (Actual)

November 3, 2020

Last Update Submitted That Met QC Criteria

November 2, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JuvePar

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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