Comparison of Two GIC's in the Restoration of Posterior Class II Lesions in the Primary Dentition
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
1 other identifier
interventional
140
2 countries
2
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 restoration of Class II cavities in primary molars.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2023
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2023
CompletedFirst Posted
Study publicly available on registry
July 28, 2023
CompletedStudy Start
First participant enrolled
August 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2030
July 28, 2023
July 1, 2023
4 years
July 20, 2023
July 20, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Survival rate of Class II restorations
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).
24 months
Secondary Outcomes (2)
Survival rate of Class II restorations
6, 12, 36, 48 and 60 months
Individual FDI parameter assessment
Baseline, 6, 12, 24, 36, 48 and 60 months
Other Outcomes (2)
Caries Experience
Baseline, 6, 12, 24, 36, 48 and 60 months
Oral Hygiene
Baseline, 6, 12, 24, 36, 48 and 60 months
Study Arms (2)
DeltaFil
EXPERIMENTALClass II restorations are placed in primary molars after conventional cavity preparation.
Riva Self Cure HV
ACTIVE COMPARATORClass II restorations are placed in primary molars after conventional cavity preparation.
Interventions
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.
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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- DMG Dental Material Gesellschaft mbHlead
- University of Coimbracollaborator
- University Arthur Sá Earp Netocollaborator
Study Sites (2)
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
Related Publications (1)
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: 20628774BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Susanne Effenberger, Dr.
DMG Dental Material Gesellschaft mbH
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2023
First Posted
July 28, 2023
Study Start
August 1, 2023
Primary Completion (Estimated)
August 1, 2027
Study Completion (Estimated)
August 1, 2030
Last Updated
July 28, 2023
Record last verified: 2023-07