Influence of the Composition of Temporary Restorative Material on the Retention Rate and Sensitivity for Provisional Direct Restorations in Vital Teeth - Clinical Study Randomized
| Registry | NCT03437655 |
|---|---|
| Status | Unknown |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: double, treatment |
| Enrollment | 25 (Estimated) |
| Sponsor | Federal University of Uberlandia (Other) |
| Conditions | MTA, Dental Restoration, Temporary |
| Interventions | Carie removal, Relative isolation, Manipulation of the temporary material based on Zinc Oxide and Eugenol, Manipulation of the temporary material based on Mineral trioxide aggregate, Material insertion on the cavity, Finishing the temporary direct restoration (Procedure) |
| Dates | start 2018-03-20 (estimated), primary completion 2018-04-30 (estimated), completion 2018-10-30 (estimated), first posted 2018-02-19, last updated 2018-03-07 |
| Locations | 1 site in Brazil |
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The aim of this study is through a randomized clinical trial, double blind, splithmouth, evaluate the success rate (retation rate and dental sensibility) of temporary direct restorations in vital teeth. The composition of the temporary direct restoration (based on Zinc-Oxide with Eugenol; and mineral trioxide aggregate). Data will be collected, tabulated and submitted to statistical analysis.
The confection of temporary direct restoration is still verry commom in dental clinic routine, either by the time required or by biological requirements.The temporary restorations must have sufficient retention and solubility between the consultation intervals to avoid displacement and infiltration; besides being biocompatible to avoid sensitivity. The aim of this study is through a randomized clinical trial, double blind, splithmouth, evaluate the success rate (retention rate and dental sensibility) of temporary direct restoration on vital teeth. The composition of the temporary material (based on Zinc-Oxide with Eugenol; and based on mineral trioxide aggregate) will be evaluated. Twenty-five participants with at least two vital teeth with the need to confection of direct restoration (each participant) will be selected. The teeth will be randomly divided into 2 different groups according to the temporary material composition (Based on Zinc-Oxide with Eugenol; and based on mineral trioxide aggregate). Data will be collected, tabulated and submitted to statistical analysis.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Zinc oxide and eugenol | Active comparator | Procedure: Carie removal; Procedure: Relative isolation; Procedure: Manipulation of the temporary material based on Zinc Oxide and Eugenol; Procedure: Material insertion on the cavity; Procedure: Finishing the temporary direct restoration | Temporary direct restoration with zinc oxide and eugenol. |
| Mineral trioxide aggregate | Active comparator | Procedure: Carie removal; Procedure: Relative isolation; Procedure: Manipulation of the temporary material based on Mineral trioxide aggregate; Procedure: Material insertion on the cavity; Procedure: Finishing the temporary direct restoration | Temporary direct restoration with Mineral trioxide aggregate. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Healthy volunteers; both genres; presence of at least two teeth with indication of direct restoration; good oral hygiene. Exclusion Criteria: * Dentures or orthodontics; presence of periodontal disease and,or parafunctional habits; systemic disease and, or severe psychological; constant use of analgesic and, or anti-inflammatory or allergic response to dental products.
| Facility | City | Country | Status |
|---|---|---|---|
| Federal University of Uberlandia | Uberlândia, Minas Gerais | Brazil |