Fiber-reinforced Composite Core Filling in the Restoration of Endodontically Treated Molars - a Clinical Study.

NCT04111003 | Completed

• 1 other identifier: 20341 601350
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

A short fiber reinforced composite base filling material has been shown to improve the strength of a direct composite filling significantly. It prevents fracture propagation and reduces shrinkage strain. These features are needed especially in endodontically treated molars, as root-canal treated teeth are structurally compromised and their restoration is associated with technical failures such as debonding and vertical root fractures. Application on this core fiber-reinforced composite (FRC) material is simplified when compared to post and core techniques commonly used to restore endodontically treated teeth. Clinically, the use of core FRC offers a cost-effective way to restore endodontically treated molars without root canal involvement. The purpose of this study is to compare the clinical performance of endodontically treated molars restored with either direct composite restorations with a FRC substructure, or with indirect full-ceramic onlay restorations, i.e. endo-crowns.

Conditions

Dental Materials; Tooth, Nonvital

Keywords

fiber-reinforced composite

Outcome Measures

Primary Outcomes (1)

• Restoration failure detected at clinical follow-up examination

  Observer scores the restoration having a fracture or detachment that requires remaking of the restoration.

  5 years

Secondary Outcomes (3)

• Restoration fracture detected at clinical follow-up examination

  5 years

• Restored tooth demonstrates with an endodontic complication needing removal of restoration or tooth. Clinical and radiographic examination requiered.

  5 years

• Observer scores the restoration having with dental caries at clinical follow-up investigation

  5 years

Study Arms (2)

SFRC direct filling

EXPERIMENTAL

Restoration of endodontically treated tooth Endodontically treated molars are restored with direct composite restorations, using a short-FRC base filling.

Procedure: local anesthesia; Procedure: Tooth restored using SFRC filling

CEREC endocrown

ACTIVE COMPARATOR

Restoration of endodontically treated tooth Endodontically treated molars are restored with indirect ceramic CAD/CAM restorations.

Procedure: local anesthesia; Procedure: Tooth restored using Ceramic indirect endocrown

Interventions

local anesthesia PROCEDURE

administering local anesthesia in the region of the planned restorative procedure

CEREC endocrown; SFRC direct filling

Tooth restored using SFRC filling PROCEDURE

Restoration of an endodontivally treated molar using a shor-fiber base filling and veneering composite

SFRC direct filling

Tooth restored using Ceramic indirect endocrown PROCEDURE

Restoration of an endodontically treated molar using a ceramic indirect restoration

CEREC endocrown

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• need for a restoration in a endodontically treated upper of lower molar tooth
• adequate coronal tooth substance present for an adhesive restorative technique

You may not qualify if:

• propable sleep bruxism
• active periodontitis
• disability to performs oral hygiene measures
• periapical parodontitis in the study tooth
• low quality of root canal obturation
• fracture-line detected at cavity preparation
• no enamel present
• less than 2mm of coronal tissue present in average
• no opposing tooth

Sponsors & Collaborators

• University of Turku: lead
• GC Europe: collaborator
• City of Turku: collaborator

Related Publications (10)

• Sarrett DC. Clinical challenges and the relevance of materials testing for posterior composite restorations. Dent Mater. 2005 Jan;21(1):9-20. doi: 10.1016/j.dental.2004.10.001.

  PMID: 15680997 BACKGROUND

• van Dijken JW, Sunnegardh-Gronberg K. Fiber-reinforced packable resin composites in Class II cavities. J Dent. 2006 Nov;34(10):763-9. doi: 10.1016/j.jdent.2006.02.003. Epub 2006 Mar 31.

  PMID: 16580114 BACKGROUND

• Manhart J. Direct composite restorations in posterior region: a case history using a nanohybrid composite. Dent Today. 2004 Nov;23(11):66, 68-70. No abstract available.

  PMID: 15622879 BACKGROUND

• Torbjorner A, Karlsson S, Odman PA. Survival rate and failure characteristics for two post designs. J Prosthet Dent. 1995 May;73(5):439-44. doi: 10.1016/s0022-3913(05)80072-1.

  PMID: 7658393 BACKGROUND

• Garoushi S, Lassila LV, Tezvergil A, Vallittu PK. Load bearing capacity of fibre-reinforced and particulate filler composite resin combination. J Dent. 2006 Mar;34(3):179-84. doi: 10.1016/j.jdent.2005.05.010. Epub 2005 Sep 8.

  PMID: 16150524 BACKGROUND

• Garoushi SK, Lassila LV, Tezvergil A, Vallittu PK. Fiber-reinforced composite substructure: load-bearing capacity of an onlay restoration and flexural properties of the material. J Contemp Dent Pract. 2006 Sep 1;7(4):1-8.

  PMID: 16957785 BACKGROUND

• Fennis WM, Kuijs RH, Kreulen CM, Verdonschot N, Creugers NH. Fatigue resistance of teeth restored with cuspal-coverage composite restorations. Int J Prosthodont. 2004 May-Jun;17(3):313-7.

  PMID: 15237878 BACKGROUND

• Tezvergil A, Lassila LV, Vallittu PK. The effect of fiber orientation on the polymerization shrinkage strain of fiber-reinforced composites. Dent Mater. 2006 Jul;22(7):610-6. doi: 10.1016/j.dental.2005.05.017. Epub 2005 Oct 18.

  PMID: 16239026 BACKGROUND

• Garoushi S, Tanner J, Vallittu P, Lassila L. Preliminary clinical evaluation of short fiber-reinforced composite resin in posterior teeth: 12-months report. Open Dent J. 2012;6:41-5. doi: 10.2174/1874210601206010041. Epub 2012 Jan 6.

  PMID: 22408696 BACKGROUND

• van Dijken JW, Hasselrot L. A prospective 15-year evaluation of extensive dentin-enamel-bonded pressed ceramic coverages. Dent Mater. 2010 Sep;26(9):929-39. doi: 10.1016/j.dental.2010.05.008. Epub 2010 Jun 17.

  PMID: 20691334 BACKGROUND

MeSH Terms

Conditions

Tooth, Nonvital

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Pekka K Vallittu, professor

  University of Turku

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor, Department of Prosthetic Dentistry and Stomatognathic Physiology

Study Record Dates

• First Submitted: October 29, 2017
• First Posted: October 1, 2019
• Study Start: December 11, 2012
• Primary Completion: February 12, 2017
• Study Completion: February 6, 2019
• Last Updated: October 8, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share