Status:
NOT_YET_RECRUITING
Comparison of Two GIC's in the Restoration of Posterior Class II Lesions in the Primary Dentition
Lead Sponsor:
DMG Dental Material Gesellschaft mbH
Collaborating Sponsors:
University of Coimbra
University Arthur Sá Earp Neto
Conditions:
Dental Caries
Eligibility:
All Genders
4-8 years
Phase:
NA
Brief 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 rest...
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 restorat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2030
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT05965297
Start Date
August 1 2023
End Date
August 1 2030
Last Update
July 28 2023
Active Locations (2)
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1
University Arthur Sá Earp Neto, Dental School - Pediatric Dentistry Clinic
Petrópolis, Brazil
2
University of Coimbra, Faculty of Medicine, Paediatric and Preventive Dentistry Institute
Coimbra, Portugal