Primary Molars Restorations With Encapsulated or Hand-Mixed Glass Ionomer: Clinical Trial
Minimally Invasive Restorations in Primary Molars Using Encapsulated ou Hand-mixed Glass Ionomer Cement: Clinical Trial With 24 Months of Follow-up
1 other identifier
interventional
145
1 country
1
Brief Summary
The aim of this RCT is to evaluate the survival of different glass ionomer cement in minimally invasive restorations, with different handling characteristics: hand-mixed versus encapsulated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2014
Typical duration for not_applicable
1 active site
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
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 15, 2014
CompletedFirst Posted
Study publicly available on registry
October 24, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2016
CompletedMarch 11, 2021
March 1, 2021
2 years
October 15, 2014
March 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Restorations survival
The survival of restorations will be evaluated over 24 months according to the Frencken and Holmgren (1999) index for occlusal cavities and Roeleveld (2006) for occlusoproximal cavities.
24 months
Secondary Outcomes (1)
Cost-Effectiveness
24 months
Study Arms (2)
Restorations with Encapsulated material
EXPERIMENTALRestorations performed with encapsulated glass ionomer cement (EQUIA - GC Corp). Capsules with glass ionomer will be activated and applied after selective carious tissue removal in primary molars.
Restorations with Hand-Mixed material
ACTIVE COMPARATORRestorations will be performed with hand-mixed glass ionomer cement (Fuji IX - GC Corp) after selective carious tissue removal in primary molars.
Interventions
restoration with hand-mixed glass ionomer cement
restoration with encapsulated ionomer cement
Eligibility Criteria
You may qualify if:
- Children who have sought treatment in the School of Dentistry, University of Sao Paulo;
- Children between 3 and 10 years old without systemic diseases;
- Children presenting at least one dentin caries cavity in primary teeth (occlusal or oclusoproximal) with no signs of pulp involvement.
You may not qualify if:
- Children whose parents did not agree to participate in the study;
- Children with behavioural issues at the initial exam or who did not assent to participate in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Sao Paulo
São Paulo, 05508-000, Brazil
Related Publications (1)
Oliveira RC, Camargo LB, Novaes TF, Pontes LRA, Olegario IC, Gimenez T, Passaro AL, Tedesco TK, Braga MM, Mendes FM, Raggio DP. Survival rate of primary molar restorations is not influenced by hand mixed or encapsulated GIC: 24 months RCT. BMC Oral Health. 2021 Jul 23;21(1):371. doi: 10.1186/s12903-021-01710-0.
PMID: 34301217DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniela Raggio, Professor
University of Sao Paulo
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 15, 2014
First Posted
October 24, 2014
Study Start
October 1, 2014
Primary Completion
October 1, 2016
Study Completion
October 1, 2016
Last Updated
March 11, 2021
Record last verified: 2021-03