Ignite Creation Date:
2024-05-06 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 12:52 PM
Study NCT ID:
NCT03637946
Status:
COMPLETED
Last Update Posted:
2020-02-05
First Post:
2018-08-10
Brief Title:
Release of Organic Components of a GIOMER in Non-carious Cervical Lesion Restorations
Sponsor:
Federal University of Minas Gerais
Organization:
Federal University of Minas Gerais
Study Overview
Official Title:
Release of Organic Components of a GIOMER in Non-carious Cervical Lesion Restorations in Vitro and in Vivo Studies
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To evaluated the clinical performance of composite resin restorations considering also the evaluation of release of resin components into saliva and the presence cytokines in gingival fluid Restorative system FL-Bond II self-etching adhesive system beautifil II composite restorative were use For in vitro assays adhesive and resin specimens are being preparing for assessing the monomers degree of conversion by FTIR sorption and solubility and release of resinous components in ethanol and Ringer solutions through a gas chromatography and mass spectroscopy - GC-MS In the longitudinal clinical study clinical performance of restorations and periodontal response were evaluate
Detailed Description:
Release of components of a resin composite system containing pre-reagent vitreal particles laboratory and patient studies The objectives of this study was to evaluate physical and chemical properties of a methacrylate-based restorative system regarding to the release of resin components to the storage medium to evaluate the clinical performance of composite resin restorations considering also the evaluation of release of resin components into saliva and the presence of cytokines in gingival crevicular fluid Restorative system FL-Bond II self-etching adhesive system beautifil II composite restorative were use For in vitro assays adhesive and resin specimens are being preparing for assessing the monomers degree of conversion by FTIR sorption and solubility and release of resinous components in ethanol and Ringer solutions through a gas chromatography and mass spectroscopy - GC-MS In the longitudinal clinical study patients who present a NCCL with restorative need were selecting Prior to treatment there will be periodontal evaluation saliva and gingival crevicular fluid collection controls The lesions were restoring with the restorative system After 10 min7 days 1 and 6 months clinical performance of restorations and periodontal response were evaluate according to the criterion FDI Additionally in all of these evaluation periods samples of saliva and crevicular fluid are being collecting Saliva samples will be analyze by GC-MS to identify the eventual presence of organic components derived from the restoration The crevicular fluid samples were analyzing using ELISA for identification and quantification of interleukins
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RBR-8m8cf2 | REGISTRY | Registro Brasileiro de Ensaios Clínicos | None |