Influence of the Composition of Temporary Restorative Material in Vital Teeth

MTA Clinical Trial

Official title:

Influence of the Composition of Temporary Restorative Material on the Retention Rate and Sensitivity for Provisional Direct Restorations in Vital Teeth - Clinical Study Randomized

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03437655
• Other study ID #: 2.358.776
• Status: Not yet recruiting
• Phase: N/A
• First received: February 11, 2018
• Last updated: March 6, 2018
• Start date: March 20, 2018
• Est. completion date: October 30, 2018

Study information

• Verified date: March 2018
• Source: Federal University of Uberlandia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: October 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dental Restoration, Temporary
• MTA

Intervention

Procedure:
• Carie removal
Carie removal with a low speed handpiece
• Relative isolation
Relative isolation with cotton and gauze.
• 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
• 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
• Material insertion on the cavity
Material insertion on the cavity according to the manufacturer's recommendations
• Finishing the temporary direct restoration
Excess cement removal; Occlusal Adjustment; Finishing and polishing.

Locations

Country	Name	City	State
Brazil	Federal University of Uberlandia	Uberlandia	Minas Gerais

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Uberlandia

Country where clinical trial is conducted

Brazil, 

References & Publications (9)

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. — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

Koumjian JH, Nimmo A. Evaluation of fracture resistance of resins used for provisional restorations. J Prosthet Dent. 1990 Dec;64(6):654-7. — View Citation

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. Review. — View Citation

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. — View Citation

von Arx T. [Mineral trioxide aggregate (MTA) a success story in apical surgery]. Swiss Dent J. 2016;126(6):573-95. Review. French, German. — View Citation

Young HM, Smith CT, Morton D. Comparative in vitro evaluation of two provisional restorative materials. J Prosthet Dent. 2001 Feb;85(2):129-32. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success rate (retention rate and absence of sensibility) of temporary direct restoration with diferents temporary materials with a 15 days of follow up		15 days