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Immunological and Regenerative Implications of Corrosion of Dental Materials (IMUNODENT)

Primary Purpose

Caries; Enamel, Gingivitis

Status
Completed
Phase
Phase 2
Locations
Croatia
Study Type
Interventional
Intervention
Exposure to oral antiseptics or enamel remineralisation agent
Sponsored by
University of Rijeka
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Caries; Enamel focused on measuring Oral antiseptics, remineralisation agents

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • patients allergic to fluoride agents and chlorhexidine gluconate

Sites / Locations

  • University of Rijeka Faculty of Dental Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

high concentration enamel remineralisation agent

oral antiseptic

Control

Arm Description

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)

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)

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)

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Dental arch shape
Measuring anterior and posterior dental arch width (in millimeters), anterior depth and depth to width ratio in orthodontic patients wearing uncoated nickel-titanium 0.020''x0.020'' archwire on the day of putting the archwire and on the day of removing it.
Oral hygiene
Assessing accumulation of dental biofilm with Modified Silness and Loe Plaque Index (0-3; 0=no plaque and 3=continuous line of dental bacterial plaque more than 1 millimetre).
pH of dental biofilm
Measuring pH of dental biofilm (colorimetric test with pH scale range from 4 to 7).
Gingivitis
Assessing extent of gingivitis by Full Mouth Bleeding Score (percentage).
Corrosion of dental alloy
Potential of corrosion, passive film breakdown and repassivation (mV)
Surface roughness of dental alloy
Surface roughness assessed by Atomic Force Microscopy (nm)
Friction of dental alloy
Friction coefficient (no units)
Forces produced by dental alloy
Load and unload forces measured by three-point bend test (N)
Hardness of dental alloy
Vickers Pyramid Number (HV)
Stifness of dental alloy
Young's modulus and yield strength (GPa)
Elasticity of dental alloy
Modulus of resilience and springback ratio (MJ/m-3)

Full Information

First Posted
October 30, 2017
Last Updated
May 20, 2022
Sponsor
University of Rijeka
Collaborators
Croatian Science Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03334461
Brief Title
Immunological and Regenerative Implications of Corrosion of Dental Materials
Acronym
IMUNODENT
Official Title
Immunological and Regenerative Implications of Corrosion of Dental Materials in Children and Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
December 1, 2015 (Actual)
Primary Completion Date
March 30, 2022 (Actual)
Study Completion Date
May 17, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rijeka
Collaborators
Croatian Science Foundation

4. Oversight

5. Study Description

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.
Detailed Description
Tooth movement with appliances based on nickel and titanium has got great osteogenic potential and can regenerate deficient parts of alveolar bone and gingiva and rehabilitate compromised occlusal relations and a patient's masticatory function. Due to the extended duration of this therapy, different procedures are carried out and materials are applied for prevention and regeneration of damaged enamel and oral mucosa. The oral cavity may be considered a galvanic cell in which dental alloys act as electrodes, while saliva and oral preventive and regenerative agents act as electrolites. The interaction causes corrosion, reduction of elasticity and increase of stiffness of appliances, which may in turn result in excessive forces, a disruption of tissue regeneration and irreparable damage of tooth roots, surrounding alveolar bone, periodontal ligament, gingiva and pulp. During the extended exposion, released corrosive products in surrounding tissues and those transported in saliva and blood may cause a series of side effects from hypersensitivity reactions and soft tissue proliferation to cyto and genotoxicity. Today, allergies are ever more frequent and arise earlier in life. A specific group are children and young adolescents in pubertal growth, a period in which the immune system develops. Nickel is one of the strongest contact allergens, present in numerous dental alloys. Nickel allergy is occurs in up to 28.5% of population and cannot be deemed as low potential risk anymore. In contrast, titan was considered a biocompatible material of no allergic potential. However, there is an increase in the frequency of presentations of different hypersensitivity reactions to titan, especially in patients with pacemakers. Numerous patients with hip endoprostheses, stents, dental implans and orthodontic appliances are exposed to titan. Titan allergy may be the cause of unexplained cases of failure and rejection of dental implants. Nickel and titan could cause bacterial resistance to antibiotics which may complicate treatment of a series of infections that are more frequent in children and adolescents. Regulations for safety of medical products regulate safety issues of materials through mandatory laboratory testing and expertise. However, the testing of interactions of these materials with newly formed materials for prevention of damage and regeneration of orodental tissues is not obligatory prior to the start of their commercial use. Such testing should be conducted by independent scientific insitutions and not by producers with direct commercial interest. The aim of this project is to investigate: the corrosion of dental materials and appliances based on nickel and titan (in saliva and due to interaction with probiotics, remineralising agents and antiseptics) the immune potential of nickel and titan ions (development of allergies, changes in cariogenic potential of dental plaque, resistency of gingivitis to therapy, and bacterial resistance to antibiotics) the effect of nickel and titan ions cellular level changes in performance of dental appliances with repercussion on regeneration of bone and periodontal tissues.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caries; Enamel, Gingivitis
Keywords
Oral antiseptics, remineralisation agents

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trail
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Unlabeled bottles containing testing agent
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
high concentration enamel remineralisation agent
Arm Type
Experimental
Arm Description
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)
Arm Title
oral antiseptic
Arm Type
Experimental
Arm Description
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)
Arm Title
Control
Arm Type
No Intervention
Arm Description
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)
Intervention Type
Combination Product
Intervention Name(s)
Exposure to oral antiseptics or enamel remineralisation agent
Primary Outcome Measure Information:
Title
Reaction of oral bacterial flora to oral antiseptics and dental remineralisation agents
Description
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.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Dental arch shape
Description
Measuring anterior and posterior dental arch width (in millimeters), anterior depth and depth to width ratio in orthodontic patients wearing uncoated nickel-titanium 0.020''x0.020'' archwire on the day of putting the archwire and on the day of removing it.
Time Frame
90 days
Title
Oral hygiene
Description
Assessing accumulation of dental biofilm with Modified Silness and Loe Plaque Index (0-3; 0=no plaque and 3=continuous line of dental bacterial plaque more than 1 millimetre).
Time Frame
210 days
Title
pH of dental biofilm
Description
Measuring pH of dental biofilm (colorimetric test with pH scale range from 4 to 7).
Time Frame
210 days
Title
Gingivitis
Description
Assessing extent of gingivitis by Full Mouth Bleeding Score (percentage).
Time Frame
210 days
Title
Corrosion of dental alloy
Description
Potential of corrosion, passive film breakdown and repassivation (mV)
Time Frame
90 days
Title
Surface roughness of dental alloy
Description
Surface roughness assessed by Atomic Force Microscopy (nm)
Time Frame
90 days
Title
Friction of dental alloy
Description
Friction coefficient (no units)
Time Frame
90 days
Title
Forces produced by dental alloy
Description
Load and unload forces measured by three-point bend test (N)
Time Frame
90 days
Title
Hardness of dental alloy
Description
Vickers Pyramid Number (HV)
Time Frame
90 days
Title
Stifness of dental alloy
Description
Young's modulus and yield strength (GPa)
Time Frame
90 days
Title
Elasticity of dental alloy
Description
Modulus of resilience and springback ratio (MJ/m-3)
Time Frame
90 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stjepan Spalj, PhD
Organizational Affiliation
University of medicine Rijeka
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rijeka Faculty of Dental Medicine
City
Rijeka
ZIP/Postal Code
51000
Country
Croatia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33566077
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Citation
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.
Results Reference
result
Links:
URL
http://arhiva.medri.uniri.hr/~spaljs/
Description
all data concerning research project are available at link (Immune and regenerative implications of corrosion of dental materials in children and adolescents)
URL
https://sites.google.com/view/ip-2020-02/početna-stranica
Description
all data concerning new project are available at link (Environmental factors and microbiological interactions in the structure of dental biofilm)

Learn more about this trial

Immunological and Regenerative Implications of Corrosion of Dental Materials

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