Chairside Mouthrinse Test and Cost Effectiveness

Periodontitis, Juvenile Clinical Trial

— JuvePar  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04139863
• Other study ID #: JuvePar
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: November 2, 2020

Study information

• Verified date: November 2020
• Source: University of Helsinki
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: November 2, 2020
• Est. primary completion date: November 2, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Aggressive Periodontitis
• Periodontitis
• Periodontitis, Juvenile

Intervention

Diagnostic Test:
• aMMP-8 chairside test
No test

Locations

Country	Name	City	State
Finland	Anna Maria Heikkinen	Helsinki	Helsinki University

Sponsors (1)

Lead Sponsor	Collaborator
University of Helsinki

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	aMMP-8 test	Mouth rinse samples are analysed by method for chair-side diagnostic testing: the aMMP-8 specific lateral-?ow 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