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Research Article
Daniela Prócida Raggio
University of São Paulo
Corresponding Author
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Background: Glass ionomer cements (GIC) have been considered the top option to restore primary teeth by dentists. The most common supply forms are hand-mixed and encapsulated GIC. There is a lack of information about the impact of different GIC supply forms on restoration survival. This randomized clinical trial compared the survival rate of occlusal and occlusoproximal restorations in primary molars using two of glass ionomer cements versions: hand-mixed (H/M) and encapsulated (ENC) after 24 months. Children aged 3-10 years who presented dentin caries lesions in primary molars were selected at School of Dentistry, University of São Paulo, Brazil. They were randomly assigned to groups: H /M (Fuji IX®, GC Europe) or ENC (Equia Fill®, GC Europe). The occurrence of restoration failure was evaluated by two blinded and calibrated examiners. The analyses were performed in Stata 13 (StataCorp, USA). To evaluate the primary outcome (restoration survival), we performed an intention to treat (ITT) analysis at 24 months of follow-up. Kaplan-Meier survival analysis was used to verify the survival of the restorations while Cox Regression with shared frailty was performed to assess association between restoration failure and independent variables (α=5%).
Results: A total of 324 restorations were performed in 145 children. The survival for H/M group was 58.2% and 60.1% for ENC, with no difference (p=0.738). Occlusoproximal restorations had lower survival rate when compared to occlusal ones (HR=3.83; p<0.001).
Conclusions: The survival rate in primary molar is not influenced by the different supply forms of GIC
This randomized clinical trial was registered on ClinicalTrials.Gov on 10/15/2014 under protocol (NCT 02274142).
Keywords
Dental Restoration, Glass ionomer cement, Randomized Clinical Trials.
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- AdditionalFile1.docx
Frencken and Holmgren Criteria for occlusal restorations
- AdditionalFile2.docx
Roeleveld et al. criteria for occlusoproximal restorations
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Subject Areas
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This preprint is under consideration at BMC Oral Health. A preprint is a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research Article
Daniela Prócida Raggio
University of São Paulo
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Under Review
Version 1
Posted 19 Mar, 2021
No community comments so far
Review #7 received
Received 18 Mar, 2021
Review #4 received
Received 18 Mar, 2021
Review #5 received
Received 18 Mar, 2021
Review #2 received
Received 18 Mar, 2021
Review #6 received
Received 18 Mar, 2021
Review #1 received
Received 18 Mar, 2021
Reviewer #9 agreed
On 18 Mar, 2021
Reviewer #1 agreed
On 18 Mar, 2021
Reviewer #6 agreed
On 18 Mar, 2021
Reviewer #7 agreed
On 18 Mar, 2021
Reviewer #4 agreed
On 18 Mar, 2021
Reviewer #2 agreed
On 18 Mar, 2021
Reviewer #8 agreed
On 18 Mar, 2021
Reviewer #3 agreed
On 18 Mar, 2021
Reviewers invited
Invitations sent on 18 Mar, 2021
Editor assigned
On 18 Mar, 2021
Editor invited
On 18 Mar, 2021
Submission checks complete
On 18 Mar, 2021
First submitted
On 03 Mar, 2021
Subject Areas
Dentistry
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: Glass ionomer cements (GIC) have been considered the top option to restore primary teeth by dentists. The most common supply forms are hand-mixed and encapsulated GIC. There is a lack of information about the impact of different GIC supply forms on restoration survival. This randomized clinical trial compared the survival rate of occlusal and occlusoproximal restorations in primary molars using two of glass ionomer cements versions: hand-mixed (H/M) and encapsulated (ENC) after 24 months. Children aged 3-10 years who presented dentin caries lesions in primary molars were selected at School of Dentistry, University of São Paulo, Brazil. They were randomly assigned to groups: H /M (Fuji IX®, GC Europe) or ENC (Equia Fill®, GC Europe). The occurrence of restoration failure was evaluated by two blinded and calibrated examiners. The analyses were performed in Stata 13 (StataCorp, USA). To evaluate the primary outcome (restoration survival), we performed an intention to treat (ITT) analysis at 24 months of follow-up. Kaplan-Meier survival analysis was used to verify the survival of the restorations while Cox Regression with shared frailty was performed to assess association between restoration failure and independent variables (α=5%).
Results: A total of 324 restorations were performed in 145 children. The survival for H/M group was 58.2% and 60.1% for ENC, with no difference (p=0.738). Occlusoproximal restorations had lower survival rate when compared to occlusal ones (HR=3.83; p<0.001).
Conclusions: The survival rate in primary molar is not influenced by the different supply forms of GIC
This randomized clinical trial was registered on ClinicalTrials.Gov on 10/15/2014 under protocol (NCT 02274142).
Figure 1
Figure 2
Figure 3
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