Comparison of Two GIC's in the Restoration of Posterior Class II Lesions in the Primary Dentition
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: DeltaFil, Riva Self Cure HV.
- Who it may be relevant to
- Registry conditions: Dental Caries. Basic parameters: 4 years — 8 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil, Portugal
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Comparison of Two Conventional Glass Ionomer Cements in the Restoration of Posterior Class II Lesion in the Primary Dentition: a Randomized Controlled Non Inferiority Trial
Overview
This study will investigate the clinical performance of a novel restorative glass ionomer (DeltaFil, DMG) in comparison to an established restorative glass ionomer (Riva Self Cure HV, SDI) in the restoration of Class II cavities in primary molars.
Detailed description
Dental caries (tooth decay) remains one of the most prevalent diseases worldwide. It is a dynamic and continuous process that, if uncontrolled, eventually leads to cavitation and the need for restorative treatment to maintain the form and function of the tooth.Today there are many possibilities for direct restorations, e.g. resin composites, compomers, resin-modified glass ionomer cements (RMGICs) and glass ionomer cements (GICs), which all offer their own advantages and disadvantages.
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).
Interventions
- Device 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. - Device 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.
Primary outcome measures
- Survival rate of Class II restorations [Time frame: 24 months]
Secondary outcome measures (2)
- Survival rate of Class II restorations [Time frame: 6, 12, 36, 48 and 60 months]
- Individual FDI parameter assessment [Time frame: Baseline, 6, 12, 24, 36, 48 and 60 months]
Eligibility criteria
Inclusion criteria
- At least 1 and up to 3 primary molars with either International Caries Detection and Assessment System (ICDAS) lesions stage 2-5 or preexisting restorations requiring placement/replacement of Class II restorations
- 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
- Known allergy/ sensitivity to GIC or other materials used in this study
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- University Arthur Sá Earp Neto, Dental School - Pediatric Dentistry Clinic — Petrópolis
Portugal · 1 center
- University of Coimbra, Faculty of Medicine, Paediatric and Preventive Dentistry Institute — Coimbra
Publications
- 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. PMID 20628774
Identifiers
NCT: NCT05965297 · DeltaFill