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.
Study summary
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.
Eligibility
Sex
ALL
Min age
4 Years
Max age
8 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Survival rate of Class II restorations — 24 months Restorations are clinically assessed using the Fédération Dentaire Internationale (FDI) criteria. A "surviving" restoration is defined as a restoration that is still present at the time of evaluation and has no individual FDI criteria with a score of 5 (clinically poor).
Trial sites (2)
Facility
City
Region
Status
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
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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