NCT03491527

Brief Summary

The aim of this study is through a randomized clinical trial, double blind, splithmouth, evaluate the success rate (post or dental crown displacement; fracture of the core/post/crown; marginal integrity and absence of endotontic alterations) of definitive indirect crowns un endodontically treated teeth. The composition of the resin cement (with and without mineral trioxide aggregate) will be evaluated. Data will be collected, tabulated and submitted to statistical analysis.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 2, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 9, 2018

Completed
22 days until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2019

Completed
Last Updated

April 9, 2018

Status Verified

April 1, 2018

Enrollment Period

5 months

First QC Date

April 2, 2018

Last Update Submit

April 2, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Success rate (post or dental crown displacement; fracture of the core/post/crown; marginal integrity and absence of endotontic alterations) of definitive indirect crowns with a 1 year follow up.

    1 year

Study Arms (2)

Conventional Resin Cement

ACTIVE COMPARATOR

Resin cement without MTA

Procedure: Absolute isolationProcedure: Manipulation of the resin cement without MTAProcedure: Fiber Post cimentationProcedure: Dental PrepareProcedure: Dental impressionProcedure: Crown cimentationProcedure: Occlusal adjustment

MTA Resin Cement

ACTIVE COMPARATOR

Resin cement with MTA

Procedure: Absolute isolationProcedure: Manipulation of the resin cement with MTAProcedure: Fiber Post cimentationProcedure: Dental PrepareProcedure: Dental impressionProcedure: Crown cimentationProcedure: Occlusal adjustment

Interventions

Absolute isolation with rubber dam

Conventional Resin CementMTA Resin Cement

Manipulation of the resin cement with MTA according to the manufacturer's recommendations.

MTA Resin Cement

Manipulation of the resin cement without MTA according to the manufacturer's recommendations.

Conventional Resin Cement

Insertion of the cement on the root canal and on post surface. Light-cured for 40 seconds on each surface.

Conventional Resin CementMTA Resin Cement

Confection of a indirect crown prepare with diamand burs.

Conventional Resin CementMTA Resin Cement

Dental impression whith silicone.

Conventional Resin CementMTA Resin Cement

Insertion of the cement on the inner surface of the crown. Light-cured for 40 seconds on each surface.

Conventional Resin CementMTA Resin Cement

Analysis of the occlusion with carbon paper.

Conventional Resin CementMTA Resin Cement

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy volunteers;
  • Presence of at least two teeth with endodontc treatment;
  • Presence of at least two teeth with indication of total crowns;
  • Good oral hygiene.

You may not qualify if:

  • Dentures or orthodontics;
  • Presence of periodontal disease
  • Presence of parafunctional habits
  • Presence of systemic disease
  • Constant use of analgesic and or anti-inflammatory
  • Allergic response to dental products

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Uberlandia

Uberlândia, Minas Gerais, 381440617, Brazil

Location

Related Publications (8)

  • Assif D, Gorfil C. Biomechanical considerations in restoring endodontically treated teeth. J Prosthet Dent. 1994 Jun;71(6):565-7. doi: 10.1016/0022-3913(94)90438-3.

    PMID: 8040817BACKGROUND
  • Bahari M, Savadi Oskoee S, Kimyai S, Mohammadi N, Saati Khosroshahi E. Effect of Light Intensity on the Degree of Conversion of Dual-cured Resin Cement at Different Depths with the use of Translucent Fiber Posts. J Dent (Tehran). 2014 May;11(3):248-55. Epub 2014 May 31.

    PMID: 25628659BACKGROUND
  • Camilleri J, Montesin FE, Brady K, Sweeney R, Curtis RV, Ford TR. The constitution of mineral trioxide aggregate. Dent Mater. 2005 Apr;21(4):297-303. doi: 10.1016/j.dental.2004.05.010.

    PMID: 15766576BACKGROUND
  • Christensen GJ. Post concepts are changing. J Am Dent Assoc. 2004 Sep;135(9):1308-10. doi: 10.14219/jada.archive.2004.0406.

    PMID: 15493395BACKGROUND
  • Duarte MA, De Oliveira Demarchi AC, Yamashita JC, Kuga MC, De Campos Fraga S. Arsenic release provided by MTA and Portland cement. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2005 May;99(5):648-50. doi: 10.1016/j.tripleo.2004.09.015.

    PMID: 15829892BACKGROUND
  • Lee SJ, Monsef M, Torabinejad M. Sealing ability of a mineral trioxide aggregate for repair of lateral root perforations. J Endod. 1993 Nov;19(11):541-4. doi: 10.1016/S0099-2399(06)81282-3.

    PMID: 8151240BACKGROUND
  • Santos-Filho PC, Castro CG, Silva GR, Campos RE, Soares CJ. Effects of post system and length on the strain and fracture resistance of root filled bovine teeth. Int Endod J. 2008 Jun;41(6):493-501. doi: 10.1111/j.1365-2591.2008.01383.x. Epub 2008 Apr 12.

    PMID: 18422584BACKGROUND
  • 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.

    PMID: 27377433BACKGROUND

MeSH Terms

Conditions

Tooth, Nonvital

Interventions

PemetrexedDental Impression TechniqueOcclusal Adjustment

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

GuanineHypoxanthinesPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DicarboxylicTechnology, DentalDentistryOrthodontics, CorrectiveOrthodontics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of NCCL Research Group

Study Record Dates

First Submitted

April 2, 2018

First Posted

April 9, 2018

Study Start

May 1, 2018

Primary Completion

September 30, 2018

Study Completion

July 30, 2019

Last Updated

April 9, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations