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Immunological and Regenerative Implications of Corrosion of Dental Materials in Children and Adolescents (IMUNODENT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03334461
Recruitment Status : Unknown
Verified May 2018 by Stjepan Spalj, University of Rijeka.
Recruitment status was:  Recruiting
First Posted : November 7, 2017
Last Update Posted : May 4, 2018
Croatian Science Foundation
Information provided by (Responsible Party):
Stjepan Spalj, University of Rijeka

Brief Summary:
During orthodontic treatment intraoral corrosion results with release of nickel and titanium ions from orthodontic appliances in surrounding tissues. Those transported in the saliva and blood may cause a series of side effects from hypersensitivity reactions and soft tissue proliferation to cyto and genotoxicity. Nickel is one of the strongest contact allergens, present in numerous dental alloys. The aim of this project is to investigate the immune potential of nickel and titan ions (development of allergies, changes in cariogenic potential of dental plaque, resistance of gingivitis to therapy, and bacterial resistance to antibiotics) and changes in performance of orthodontic appliances with repercussion on regeneration of bone and periodontal tissues.

Condition or disease Intervention/treatment Phase
Caries; Enamel Gingivitis Combination Product: Exposure to oral antiseptics or enamel remineralisation agent Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized controlled trail
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Unlabeled bottles containing testing agent
Primary Purpose: Prevention
Actual Study Start Date : December 1, 2015
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 30, 2019

Arm Intervention/treatment
Experimental: Mirafluor K gel cola 6150ppm F pH 5.1
Exposure to enamel remineralisation agent
Combination Product: Exposure to oral antiseptics or enamel remineralisation agent
Experimental: Curasept ADS 212 a 200ml 0,12%
Exposure to oral antiseptics
Combination Product: Exposure to oral antiseptics or enamel remineralisation agent
No Intervention: Placebo
Without exposure to oral antiseptic or enamel remineralisation agent

Primary Outcome Measures :
  1. Reaction of oral bacterial flora to an oral antiseptic [ Time Frame: 30 days ]
    Detection of decreased/increased count of Streptococcus mutans, sorbinus and salivarius and total bacterial count assesed by qPCR in the dental plaque before and after intervention in patients with fixed orthodontic appliances.

Secondary Outcome Measures :
  1. Patients dental arch shape [ Time Frame: 90 days ]
    Measuring anterior and posterior dental arch width (in millimeters), anterior depth and depth to width ratio in orthodontic patients wearing uncoated nickel-titanium 20x20 archwire on the day of putting the archwire and on the day of removing it.

  2. Patients oral health condition [ Time Frame: 210 days ]
    Calculating patients oral condition by measuring dental plaque accumulation with Modified Silnes and Loe plaque index (0-3; 0=no plaque and 3=continuous line of dental bacterial plaque more than 1millimeter) and its pH (colorimetric test with pH scale range from 4 to 7) as well as presence of gingivitis by Full mouth bleeding score (percentage).

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • patients with fixed orthodontic appliances
  • must be able to do a mouthwash

Exclusion Criteria:

  • patients allergic to fluoride agents and chlorhexidine gluconate

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03334461

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Contact: Stjepan Spalj, PhD 385911651333

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University of Rijeka School of Medicine Recruiting
Rijeka, Croatia, 51000
Contact: Stjepan Spalj, PhD    385911651333   
Sponsors and Collaborators
University of Rijeka
Croatian Science Foundation
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Principal Investigator: Stjepan Spalj, PhD University of medicine Rijeka
Additional Information:
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Responsible Party: Stjepan Spalj, Associate Professor, University of Rijeka Identifier: NCT03334461    
Other Study ID Numbers: IP-2014-09-7500
First Posted: November 7, 2017    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Stjepan Spalj, University of Rijeka:
Oral antiseptics
remineralisation agents
Additional relevant MeSH terms:
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Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Anti-Infective Agents, Local
Anti-Infective Agents