Immunological and Regenerative Implications of Corrosion of Dental Materials

NCT03334461 | Completed Phase 2

• 1 other identifier: IP-2014-09-7500
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Caries; Enamel; Gingivitis

Keywords

Oral antiseptics; remineralisation agents

Outcome Measures

Primary Outcomes (1)

• Reaction of oral bacterial flora to oral antiseptics and dental remineralisation agents

  Detection of change of 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.

  30 days

Secondary Outcomes (11)

• Dental arch shape

  90 days

• Oral hygiene

  210 days

• pH of dental biofilm

  210 days

• Gingivitis

  210 days

• Corrosion of dental alloy

  90 days

Study Arms (3)

high concentration enamel remineralisation agent

EXPERIMENTAL

first month brushing teeth three times per day: twice per day with high-fluorides gel (Mirafluor K gel cola 6150 ppm F pH 5.1) and once per day without toothpaste and fluoride gel next two months brushing teeth three times per day with toothpaste containing low concentration of fluorides (1450 ppm)

Combination Product: Exposure to oral antiseptics or enamel remineralisation agent

oral antiseptic

EXPERIMENTAL

first month brushing teeth without toothpaste three times per day and using oral antiseptic chlorhexidine mouthwash (Curasept ADS 212 a 200ml 0,12%) twice per day next two months brushing teeth three times per day with toothpaste containing low concentration of fluorides (1450 ppm)

Combination Product: Exposure to oral antiseptics or enamel remineralisation agent

Control

NO INTERVENTION

regular oral hygiene without exposure to oral antiseptic or high concentration enamel remineralisation agent three months brushing teeth three times per day with toothpaste containing low concentration of fluorides (1450 ppm)

Interventions

Exposure to oral antiseptics or enamel remineralisation agent COMBINATION_PRODUCT

high concentration enamel remineralisation agent; oral antiseptic

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• patients allergic to fluoride agents and chlorhexidine gluconate

Sponsors & Collaborators

• University of Rijeka: lead
• Croatian Science Foundation: collaborator

Study Sites (1)

University of Rijeka Faculty of Dental Medicine

Rijeka, 51000, Croatia

Location

Related Publications (6)

• Belasic TZ, Pejova B, Curkovic HO, Kamenar E, Cetenovic B, Spalj S. Influence of intraoral application of antiseptics and fluorides during orthodontic treatment on corrosion and mechanical characteristics of nickel-titanium alloy in orthodontic appliances. Angle Orthod. 2021 Jul 1;91(4):528-537. doi: 10.2319/052620-480.1.

  PMID: 33566077 RESULT

• Zibar Belasic T, Zigante M, Perkovic V, Uhac M, Spalj S. Comparison of dental and periodontal condition of patients unexposed and exposed to metal orthodontic appliance. Book of Abstracts of the 7th international Congress of School of Dental Medicine University of Zagreb, Rovinj, Croatia, 21.-22.05.2021. Acta Stomatol Croat. 2021;55:213-6.

  RESULT

• Zibar Belasic T, Zigante M, Uhac M, Karlovic S, Jelovica Badovinac I, Spalj S. Influence of intraoral application of antiseptics and fluorides during orthodontic treatment on biomechanics of remodeling of dental arches. 8th Virtual World Congress of Dental Students - Abstract book. Zagreb, Croatia, 2020. p. 2.

  RESULT

• Cindric L, Mohar Vitezić B, Zigante M, Spalj S, Markova Car E. Changes of bacterial profile of dental biofilm during orthodontic treatment and influence of fluorides and chlorhexidine. South Eur J Orthod Dentofac Res. Conference proceedings - 1st Congress of the Faculty of Dental medicine, University of Rijeka, Croatia, October 1st-3rd 2020. Rijeka, Hrvatska, 2020. p. 55.

  RESULT

• Zibar Belasic T, Pejova B, Otmacic Curkovic H, Kamenar E, Cetenovic B, Spalj S. Intraoral application of antiseptics and fluorides during orthodontic treatment does not affect significantly corrosion and mechanical characteristics of nickel-titanium alloy in orthodontic appliances. Prvi kongres Fakulteta dentalne medicine Sveučilišta u Rijeci, Rijeka, 1-2.10.2020. Knjiga sažetaka. South Eur J Orthod Dentofac Res 2020;7:56.

  RESULT

• Zibar Belasic T, Mohar Vitezic B, Zigante M, Spalj S, Markova Car E. Supragingival biofilm composition changes during orthodontic treatment and chlorhexidine use. Book of Abstracts 97th Annual Congress of the European Orthodontic Society, Limassol, Cipar, 30.05.-03.06.2022.

  RESULT

Related Links

• all data concerning research project are available at link (Immune and regenerative implications of corrosion of dental materials in children and adolescents)
• all data concerning new project are available at link (Environmental factors and microbiological interactions in the structure of dental biofilm)

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Stjepan Spalj, PhD

  University of medicine Rijeka

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Unlabeled bottles containing testing agent
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Model Details: Randomized controlled trail

Study Record Dates

• First Submitted: October 30, 2017
• First Posted: November 7, 2017
• Study Start: December 1, 2015
• Primary Completion: March 30, 2022
• Study Completion: May 17, 2022
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)