Influence of the Composition of Temporary Restorative Material in Vital Teeth

Overview

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.

Full Title of Study: “Influence of the Composition of Temporary Restorative Material on the Retention Rate and Sensitivity for Provisional Direct Restorations in Vital Teeth – Clinical Study Randomized”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: April 30, 2018

Detailed 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.

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: Zinc oxide and eugenol
    • Temporary direct restoration with zinc oxide and eugenol.
  • Active Comparator: Mineral trioxide aggregate
    • Temporary direct restoration with Mineral trioxide aggregate.

Clinical Trial Outcome Measures

Primary Measures

  • Success rate (retention rate and absence of sensibility) of temporary direct restoration with diferents temporary materials with a 15 days of follow up
    • Time Frame: 15 days

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Federal University of Uberlandia
  • Provider of Information About this Clinical Study
    • Principal Investigator: PAULO VINICIUS SOARES, Professor – Federal University of Uberlandia

References

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.

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.

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.

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.

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.

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.

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.

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

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.