Chairside Mouthrinse Test and Cost Effectiveness (JuvePar)

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: Periodontitis, Juvenile
• Intervention / Treatment: Diagnostic test: aMMP-8 chairside test

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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

• Sponsor: University of Helsinki

Study record dates

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: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Aggressive Periodontitis
• 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