Comparison of Two GIC's in the Restoration of Posterior Class II Lesions in the Primary Dentition
NCT ID: NCT05965297
Last Updated: 2023-07-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
140 participants
INTERVENTIONAL
2023-08-31
2030-08-31
Brief Summary
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Detailed Description
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GIC are particularly suitable for treatments in young patients due to their high biocompatibility, fluoride release, less moisture and technique sensitivity as well as compatibility with Atraumatic restorative treatment (ART) treatment. However, these materials have lower mechanical properties compared to other restorative materials, which negatively affects the survival rate when placed in load bearing areas. Fracture, loss and wear being the most common causes for failure.
This randomized, controlled non-inferiority trial aims to evaluate the performance of the new restorative glass ionomer DeltaFil, that offers an increased fracture toughness, in comparison to an established restorative glass-ionomer (Riva Self Cure HV).
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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DeltaFil
Class II restorations are placed in primary molars after conventional cavity preparation.
DeltaFil
Cavities are prepared using rotary instruments/diamond burs. Afterwards, the cavity is conditioned (using DeltaFil conditioner) and cleaned, with subsequent insertion of a conventional restorative glass-ionomer (DeltaFil). During the curing phase and after finishing Riva Coat will be applied to all restoration surfaces for moisture protection.
Riva Self Cure HV
Class II restorations are placed in primary molars after conventional cavity preparation.
Riva Self Cure HV
Cavities are prepared using rotary instruments/diamond burs. Afterwards, the cavity is conditioned (using Riva conditioner) and cleaned, with subsequent insertion of a conventional restorative glass-ionomer (Riva Self Cure HV). During the curing phase and after finishing Riva Coat will be applied to all restoration surfaces for moisture protection.
Interventions
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DeltaFil
Cavities are prepared using rotary instruments/diamond burs. Afterwards, the cavity is conditioned (using DeltaFil conditioner) and cleaned, with subsequent insertion of a conventional restorative glass-ionomer (DeltaFil). During the curing phase and after finishing Riva Coat will be applied to all restoration surfaces for moisture protection.
Riva Self Cure HV
Cavities are prepared using rotary instruments/diamond burs. Afterwards, the cavity is conditioned (using Riva conditioner) and cleaned, with subsequent insertion of a conventional restorative glass-ionomer (Riva Self Cure HV). During the curing phase and after finishing Riva Coat will be applied to all restoration surfaces for moisture protection.
Eligibility Criteria
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Inclusion Criteria
* Defects limited to occlusal-proximal surface, with cavity sizes smaller than 3 mm mesio-distally and 3 mm in the occluso-cervical and bucco-lingual directions measured with a World Health Organization (WHO)-graded periodontal probe
* Teeth should have both adjoining and their antagonist teeth present. After restoration the restored tooth should enable appropriate proximal contacts on both mesial and distal surfaces after setting of the class II restoration and be in occlusion with the antagonist tooth
* Good access
* Good general health (ASA I, II)
* Good oral hygiene (OHI-S \< 1.9)
* Guardians have given informed consent
* Child is cooperative and assented
Exclusion Criteria
* Space maintainers or orthodontic appliances
* Tooth has a caries lesion or restoration other than those included in the study
* Tooth has pathological mobility
* Tooth has preexisting developmental defects
* Tooth with pulp exposure or indication for endodontic treatment
* Pain, fistula or abscess related to the selected tooth
* Obvious signs of parafunctional habits (e.g. bruxism)
* Participation in another study
* Incapable to participate in the recall visits at the university hospital
4 Years
8 Years
ALL
No
Sponsors
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University of Coimbra
OTHER
University Arthur Sá Earp Neto
UNKNOWN
DMG Dental Material Gesellschaft mbH
INDUSTRY
Responsible Party
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Principal Investigators
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Susanne Effenberger, Dr.
Role: STUDY_CHAIR
DMG Dental Material Gesellschaft mbH
Locations
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University Arthur Sá Earp Neto, Dental School - Pediatric Dentistry Clinic
Petrópolis, , Brazil
University of Coimbra, Faculty of Medicine, Paediatric and Preventive Dentistry Institute
Coimbra, , Portugal
Countries
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Central Contacts
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Facility Contacts
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Ana Luísa Costa, Prof.
Role: primary
Maria Teresa Xavier, Prof.
Role: backup
References
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Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.
Other Identifiers
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DeltaFill
Identifier Type: -
Identifier Source: org_study_id