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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	30 May 2022
Main ID:	NCT03334461
Date of registration:	30/10/2017
Prospective Registration:	No
Primary sponsor:	University of Rijeka
Public title:	Immunological and Regenerative Implications of Corrosion of Dental Materials IMUNODENT
Scientific title:	Immunological and Regenerative Implications of Corrosion of Dental Materials in Children and Adolescents
Date of first enrolment:	December 1, 2015
Target sample size:	60
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT03334461
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
Phase:	Phase 2

Countries of recruitment
Croatia

Contacts

Name:	Stjepan Spalj, PhD
Address:
Telephone:
Email:
Affiliation:	University of medicine Rijeka

Key inclusion & exclusion criteria

Inclusion Criteria:

- patients with fixed orthodontic appliances

- must be able to do a mouthwash

Exclusion Criteria:

- patients allergic to fluoride agents and chlorhexidine gluconate

Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Caries; Enamel

Gingivitis

Intervention(s)

Combination Product: Exposure to oral antiseptics or enamel remineralisation agent

Primary Outcome(s)

Reaction of oral bacterial flora to oral antiseptics and dental remineralisation agents [Time Frame: 30 days]

Secondary Outcome(s)

Friction of dental alloy [Time Frame: 90 days]

Corrosion of dental alloy [Time Frame: 90 days]

Dental arch shape [Time Frame: 90 days]

Gingivitis [Time Frame: 210 days]

Surface roughness of dental alloy [Time Frame: 90 days]

pH of dental biofilm [Time Frame: 210 days]

Oral hygiene [Time Frame: 210 days]

Forces produced by dental alloy [Time Frame: 90 days]

Elasticity of dental alloy [Time Frame: 90 days]

Hardness of dental alloy [Time Frame: 90 days]

Stifness of dental alloy [Time Frame: 90 days]

Secondary ID(s)

IP-2014-09-7500

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Croatian Science Foundation

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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