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Chairside Mouthrinse Test and Cost Effectiveness (JuvePar)

Primary Purpose

Periodontitis, Juvenile

Status
Unknown status
Phase
Not Applicable
Locations
Finland
Study Type
Interventional
Intervention
aMMP-8 chairside test
Sponsored by
University of Helsinki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Periodontitis, Juvenile

Eligibility Criteria

14 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Anna Maria Heikkinen

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

aMMP-8 chairside test

No test

Arm Description

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.

The other group is control group. No test administered.

Outcomes

Primary Outcome Measures

aMMP-8 test
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.

Secondary Outcome Measures

Full Information

First Posted
October 7, 2019
Last Updated
November 2, 2020
Sponsor
University of Helsinki
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1. Study Identification

Unique Protocol Identification Number
NCT04139863
Brief Title
Chairside Mouthrinse Test and Cost Effectiveness
Acronym
JuvePar
Official Title
Pilot Study on Oral Health Status Chairside Mouthrinse Test in Finnish Adolescents and Cost Effectiveness of the Test
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2017 (Actual)
Primary Completion Date
November 2, 2020 (Anticipated)
Study Completion Date
November 2, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Helsinki

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis, Juvenile

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
aMMP-8 chairside test
Arm Type
Other
Arm Description
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.
Arm Title
No test
Arm Type
No Intervention
Arm Description
The other group is control group. No test administered.
Intervention Type
Diagnostic Test
Intervention Name(s)
aMMP-8 chairside test
Other Intervention Name(s)
No test
Intervention Description
No test
Primary Outcome Measure Information:
Title
aMMP-8 test
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
14 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Anna Maria Heikkinen
City
Helsinki
State/Province
Helsinki University
ZIP/Postal Code
FI-00014
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No

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Chairside Mouthrinse Test and Cost Effectiveness

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