CClinicalTrials.gg
Status unknownNCT03437655Updated Mar 7, 2018

Influence of the Composition of Temporary Restorative Material in Vital Teeth

An interventional study of Carie removal and Relative isolation in MTA and Dental Restoration, Temporary, sponsored by Federal University of Uberlandia. Status unknown at 1 site in Brazil. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-07.

Sponsored by Federal University of Uberlandia · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
25
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • MTA
  • Dental Restoration, Temporary
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Healthy volunteers; both genres; presence of at least two teeth with indication of direct restoration; good oral hygiene.

Exclusion criteria

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
25 participants (estimated)

Study arms

  • Active comparator
    Zinc oxide and eugenol

    Temporary direct restoration with zinc oxide and eugenol.

    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

  • Active comparator
    Mineral trioxide aggregate

    Temporary direct restoration with Mineral trioxide aggregate.

    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

Interventions

  • ProcedureCarie removal

    Carie removal with a low speed handpiece

  • ProcedureRelative isolation

    Relative isolation with cotton and gauze.

  • ProcedureManipulation 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

  • ProcedureManipulation 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

  • ProcedureMaterial insertion on the cavity

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

  • ProcedureFinishing the temporary direct restoration

    Excess cement removal; Occlusal Adjustment; Finishing and polishing.

05

What researchers measure

Primary outcomes

  1. 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

06

Study locations

1 site
  • Federal University of Uberlandia
    Uberlandia, Minas Gerais 381440617, Brazil
07

References and documents

Publications

  • 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. PubMed 23960554 ↗
  • 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. PubMed 27134427 ↗
  • 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. PubMed 16240963 ↗
  • 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. PubMed 21564117 ↗
  • 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. PubMed 2079670 ↗
  • 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. PubMed 26525003 ↗
  • 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. PubMed 26841969 ↗
  • 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. PubMed 27377433 ↗
  • 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. PubMed 11208201 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03437655
Lead sponsor
Federal University of Uberlandia
Responsible party
PAULO VINICIUS SOARES (Professor, Federal University of Uberlandia) — Principal investigator
First posted
Feb 19, 2018
Start date
Mar 20, 2018 (estimated)
Primary completion
Apr 30, 2018 (estimated)
Completion
Oct 30, 2018 (estimated)
Last update
Mar 7, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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