Chairside Mouthrinse Test and Cost Effectiveness

Not Applicable

• Conditions: Periodontitis, Juvenile
• Interventions: Diagnostic Test: aMMP-8 chairside test

• Registration Number: NCT04139863
• Lead Sponsor: University of Helsinki

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.

Study Timeline

• Study Start: 2017-09-01
• Study First Submitted: 2019-10-07
• Study First Submitted QC: 2019-10-23
• Study First Posted: 2019-10-25
• Status Verified: 2020-11
• Primary Completion: 2020-11-02
• Study Completion: 2020-11-02
• Last Update Submitted: 2020-11-02
• Last Update Posted: 2020-11-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
aMMP-8 chairside test	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.

Primary Outcome Measures

Name	Time	Method
aMMP-8 test	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.

Trial Locations

Locations (1)

Anna Maria Heikkinen; 🇫🇮 Helsinki, Helsinki University, Finland