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Clinical Trials in Portugal / NCT05965297
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Comparison of Two GIC's in the Restoration of Posterior Class II Lesions in the Primary Dentition

NCT05965297 · tracked via the Priya Life Science Portugal tracker
Sponsor
DMG Dental Material Gesellschaft mbH
Phase
Not applicable
Started
2023-08
Last updated
2023-07-28

Condition(s) studied

Dental Caries

Investigational drug(s) / intervention(s)

DeltaFilRiva Self Cure HV

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)

Trial sites (2)

FacilityCityRegionStatus
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.

View NCT05965297 on ClinicalTrials.gov ↗ ← All trials in Portugal