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NCT04491981
Restoration Repairs Using Composite Resin Versus Glass Ionomer in Primary Molars: a Randomized Clinical Trial
NA trial testing Encapsulated Glass Ionomer Cement in Dental Caries in 312 participants. Status unknown.
1 August 2022
Quick facts
| Lead sponsor | University of Sao Paulo |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 312 |
| Start date | 1 July 2021 |
| Primary completion | 1 August 2022 |
| Estimated completion | 1 August 2023 |
| Sites | 1 location across Brazil |
Drugs / interventions tested
- Encapsulated Glass Ionomer Cement
- Composite resin
Conditions studied
- Dental Caries — all drugs for Dental Caries →
- Dental Caries in Children — all drugs for Dental Caries in Children →
Sponsor
University of Sao Paulo
Who can join
Adults 3 to 10, any sex, with Dental Caries or Dental Caries in Children. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The objective of this randomized clinical study is to evaluate the survival of repairs in restorations using composite resin (CR) or high viscosity glass ionomer cement (GIC) in primary molars. This trial is nested to another study (NCT03520309), so patients will be enrolled from CARDEC 3. 312 restorations will be included and randomized into two groups: glass ionomer cement (Riva Self Cure, SDI, Australia) and composite resin (Filtek Bulk Fill and Filtek Bulk Fill Flow, 3M ESPE, USA). After the end of treatments, patients will be followed for 24 months to assess the success of the restorations, which will be considered as the absence of the need for reintervention. The Kaplan-Meier survival curves and the log-rank tests will be performed to assess survival between groups and Cox regression analysis will be used to compare the outcome with the variables (α = 5%).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04491981
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04491981 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University of Sao Paulo
- Last refreshed: 13 April 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04491981.
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