NCT04293770

Brief Summary

Clinical performance of indirect adhesive restorations - onlays, overlays- luted with light-cured composite resin will be evaluated over three years.

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
83

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

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

Study Start

First participant enrolled

December 10, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 29, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 3, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2020

Completed
Last Updated

March 5, 2020

Status Verified

March 1, 2020

Enrollment Period

6 months

First QC Date

February 29, 2020

Last Update Submit

March 3, 2020

Conditions

Dental CariesEndodontically Treated TeethDental Restoration Failure of Marginal IntegrityWear, OcclusalIndirect Posterior Restoration

Keywords

Indirect restorationAdhesive restorationCementationComposite resin

Outcome Measures

Primary Outcomes (1)

  • FDI World Dental Federation criteria

    Restorations will be evaluated clinically using dental explorer, mirror, dental loupe and radiographically according to FDI World Dental Federation criteria over 3-year period. Two calibrated observers who are not involved in the placement of the restorations are responsible for the evaluations. Esthetic properties: Surface lustre, surface staining, marginal staining, color match and translucency, esthetical anatomical form Functional properties: Fracture of material and retention, marginal adaptation, occlusal contour and wear, approximal anatomical form, radiographic examination, patient's view. Biological properties: Recurrence of caries, erosion, abfraction, tooth integrity, periodontal response, adjacent mucosa, oral and general health.

    at 3 years

Study Arms (1)

Indirect restorations luted with light-cured composite resin.

EXPERIMENTAL

Subjects for the study will be identified from patients who had treated with indirect adhesive restorations onlay or overlay during the period 2016 to 2017 was performed at Istanbul Okan University Faculty of Dentistry by an experienced clinician. Local anesthesia was applied if necessary. After caries and/or failed restorations were removed, the preparations were performed according to defined principles for adhesive onlays/overlays. At least one cuspal coverage was required for each restoration. All undercuts were eliminated using composite resin. Following the cavity preparation, immediate dentin sealing was applied and polymerized prior to impression taking. Indirect restorations were designed and fabricated with CEREC system. Surface treatments and clinical protocols were performed under manufacturer's instructions. Adhesive cementation with composite resin procedure was carried out with the rubber-dam isolation.

Device: Indirect adhesive restoration of posterior teeth

Interventions

Indirect adhesive restoration of posterior teethDEVICE

Indirect restoration of significant loss of dental hard tissue

Also known as: Ceramic onlay or overlay
Indirect restorations luted with light-cured composite resin.

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Significant loss of dental hard tissue
  • Endodontically treated teeth in posterior region
  • Replacement of large compromised existing restoration
  • Large Class II restoration
  • Age of 18-60 years
  • Good oral hygiene
  • Presence of interproximal contact to at least one neighboring teeth
  • In occlusion with antagonist teeth
  • Cavity preparation with at least one cuspal coverage

You may not qualify if:

  • Serious medical problems or allergies to substances and/or products to be used
  • Severe periodontal problems
  • Poor oral hygiene
  • Direct pulp capping
  • Presence of parafunctional behaviors
  • Pregnant or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Okan University Faculty of Dentistry

Istanbul, Tuzla, 34959, Turkey (Türkiye)

RECRUITING

Related Publications (6)

  • D'Arcangelo C, Zarow M, De Angelis F, Vadini M, Paolantonio M, Giannoni M, D'Amario M. Five-year retrospective clinical study of indirect composite restorations luted with a light-cured composite in posterior teeth. Clin Oral Investig. 2014;18(2):615-24. doi: 10.1007/s00784-013-1001-8. Epub 2013 May 22.

    PMID: 23695612BACKGROUND

  • Veneziani M. Posterior indirect adhesive restorations: updated indications and the Morphology Driven Preparation Technique. Int J Esthet Dent. 2017;12(2):204-230.

    PMID: 28653051BACKGROUND

  • Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.

    PMID: 20628774BACKGROUND

  • Magne P, Razaghy M, Carvalho MA, Soares LM. Luting of inlays, onlays, and overlays with preheated restorative composite resin does not prevent seating accuracy. Int J Esthet Dent. 2018;13(3):318-332.

    PMID: 30073216BACKGROUND

  • D'Arcangelo C, Vanini L, Casinelli M, Frascaria M, De Angelis F, Vadini M, D'Amario M. Adhesive Cementation of Indirect Composite Inlays and Onlays: A Literature Review. Compend Contin Educ Dent. 2015 Sep;36(8):570-7; quiz 578.

    PMID: 26355440BACKGROUND

  • Naeselius K, Arnelund CF, Molin MK. Clinical evaluation of all-ceramic onlays: a 4-year retrospective study. Int J Prosthodont. 2008 Jan-Feb;21(1):40-4.

    PMID: 18350945BACKGROUND

MeSH Terms

Conditions

Dental CariesTooth, NonvitalTooth Attrition

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic DiseasesDental Pulp DiseasesTooth Wear

Study Officials

  • Gulsah YENIER, DDS, PHD

    Istanbul Okan University Faculty of Dentistry

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gulsah YENIER, DDS,PhD

CONTACT

+905547810176gulsahyenier@gmail.com

Elif CIFTCIOGLU, DDS,PhD

CONTACT

+902166771630elifcif@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: A Prospective Clinical Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist.Prof.

Study Record Dates

First Submitted

February 29, 2020

First Posted

March 3, 2020

Study Start

December 10, 2019

Primary Completion

June 8, 2020

Study Completion

July 8, 2020

Last Updated

March 5, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)