Influence of the Composition of Temporary Restorative Material in Vital Teeth

NCT ID: NCT03437655

Last Updated: 2018-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-20

Study Completion Date

2018-10-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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MTA Dental Restoration, Temporary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Zinc oxide and eugenol

Temporary direct restoration with zinc oxide and eugenol.

Group Type ACTIVE_COMPARATOR

Carie removal

Intervention Type PROCEDURE

Carie removal with a low speed handpiece

Relative isolation

Intervention Type PROCEDURE

Relative isolation with cotton and gauze.

Manipulation of the temporary material based on Zinc Oxide and Eugenol

Intervention Type PROCEDURE

Manipulation of the temporary material based on Zinc Oxide and Eugenol according to the manufacturer's recommendations

Material insertion on the cavity

Intervention Type PROCEDURE

Material insertion on the cavity according to the manufacturer's recommendations

Finishing the temporary direct restoration

Intervention Type PROCEDURE

Excess cement removal; Occlusal Adjustment; Finishing and polishing.

Mineral trioxide aggregate

Temporary direct restoration with Mineral trioxide aggregate.

Group Type ACTIVE_COMPARATOR

Carie removal

Intervention Type PROCEDURE

Carie removal with a low speed handpiece

Relative isolation

Intervention Type PROCEDURE

Relative isolation with cotton and gauze.

Manipulation of the temporary material based on Mineral trioxide aggregate

Intervention Type PROCEDURE

Manipulation of the temporary material based on Mineral trioxide aggregate according to the manufacturer's recommendations

Material insertion on the cavity

Intervention Type PROCEDURE

Material insertion on the cavity according to the manufacturer's recommendations

Finishing the temporary direct restoration

Intervention Type PROCEDURE

Excess cement removal; Occlusal Adjustment; Finishing and polishing.

Interventions

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Carie removal

Carie removal with a low speed handpiece

Intervention Type PROCEDURE

Relative isolation

Relative isolation with cotton and gauze.

Intervention Type PROCEDURE

Manipulation of the temporary material based on Zinc Oxide and Eugenol

Manipulation of the temporary material based on Zinc Oxide and Eugenol according to the manufacturer's recommendations

Intervention Type PROCEDURE

Manipulation of the temporary material based on Mineral trioxide aggregate

Manipulation of the temporary material based on Mineral trioxide aggregate according to the manufacturer's recommendations

Intervention Type PROCEDURE

Material insertion on the cavity

Material insertion on the cavity according to the manufacturer's recommendations

Intervention Type PROCEDURE

Finishing the temporary direct restoration

Excess cement removal; Occlusal Adjustment; Finishing and polishing.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Uberlandia

OTHER

Sponsor Role lead

Responsible Party

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PAULO VINICIUS SOARES

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Federal University of Uberlandia

Uberlândia, Minas Gerais, Brazil

Site Status

Countries

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Brazil

References

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Al Jabbari YS, Al-Rasheed A, Smith JW, Iacopino AM. An indirect technique for assuring simplicity and marginal integrity of provisional restorations during full mouth rehabilitation. Saudi Dent J. 2013 Jan;25(1):39-42. doi: 10.1016/j.sdentj.2012.10.003. Epub 2012 Nov 10.

Reference Type BACKGROUND
PMID: 23960554 (View on PubMed)

Arora SJ, Arora A, Upadhyaya V, Jain S. Comparative evaluation of marginal leakage of provisional crowns cemented with different temporary luting cements: In vitro study. J Indian Prosthodont Soc. 2016 Jan-Mar;16(1):42-8. doi: 10.4103/0972-4052.164911.

Reference Type BACKGROUND
PMID: 27134427 (View on PubMed)

Fonseca RB, Martins LR, Quagliatto PS, Soares CJ. Influence of provisional cements on ultimate bond strength of indirect composite restorations to dentin. J Adhes Dent. 2005 Autumn;7(3):225-30.

Reference Type BACKGROUND
PMID: 16240963 (View on PubMed)

Hill EE, Lott J. A clinically focused discussion of luting materials. Aust Dent J. 2011 Jun;56 Suppl 1:67-76. doi: 10.1111/j.1834-7819.2010.01297.x.

Reference Type BACKGROUND
PMID: 21564117 (View on PubMed)

Koumjian JH, Nimmo A. Evaluation of fracture resistance of resins used for provisional restorations. J Prosthet Dent. 1990 Dec;64(6):654-7. doi: 10.1016/0022-3913(90)90290-s.

Reference Type BACKGROUND
PMID: 2079670 (View on PubMed)

Mahn E, Rousson V, Heintze S. Meta-Analysis of the Influence of Bonding Parameters on the Clinical Outcome of Tooth-colored Cervical Restorations. J Adhes Dent. 2015 Aug;17(5):391-403. doi: 10.3290/j.jad.a35008.

Reference Type BACKGROUND
PMID: 26525003 (View on PubMed)

Qudeimat MA, Alyahya A, Hasan AA. Mineral trioxide aggregate pulpotomy for permanent molars with clinical signs indicative of irreversible pulpitis: a preliminary study. Int Endod J. 2017 Feb;50(2):126-134. doi: 10.1111/iej.12614. Epub 2016 Feb 22.

Reference Type BACKGROUND
PMID: 26841969 (View on PubMed)

von Arx T. [Mineral trioxide aggregate (MTA) a success story in apical surgery]. Swiss Dent J. 2016;126(6):573-95. doi: 10.61872/sdj-2016-06-02. French, German.

Reference Type BACKGROUND
PMID: 27377433 (View on PubMed)

Young HM, Smith CT, Morton D. Comparative in vitro evaluation of two provisional restorative materials. J Prosthet Dent. 2001 Feb;85(2):129-32. doi: 10.1067/mpr.2001.112797.

Reference Type BACKGROUND
PMID: 11208201 (View on PubMed)

Other Identifiers

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2.358.776

Identifier Type: -

Identifier Source: org_study_id

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