Menu
Recruiting NCT06457737

The Performance of Posterior Partial Coverage Coronal Restorations Luted With Two Differrent Systems.

No phase Interventional Unsatisfactory or Defective Restoration of Tooth

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IPS Empress Direct, Bisco Duo-Link Universal.
Who it may be relevant to
Registry conditions: Unsatisfactory or Defective Restoration of Tooth. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Jordan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Performance of Posterior Partial Coverage Coronal Restorations Cemented Using Two Different Luting Systems. A Comparative Clinical Trial.

Overview

This study explores an alternative approach using a pre-heated restorative resin composite as a luting material of partial coverage restorations on upper and lower posterior teeth. It will follow a split-mouth design with 60 participants selected based on strict criteria. Assessment at 6 months and 1 year post-delivery utilizes a modified model of USPHS criteria, evaluating retention, color match, marginal discoloration, secondary caries, anatomical form, marginal adaptation, and surface roughness. The null hypothesis: The use of preheated resin composite for cementing partial coverage restoration will not result in significantly superior clinical performance when compared to that after using dual-cure resin cement.

Detailed description

The adhesive cementation of ceramic partial coverage restorations is a technique-sensitive process essential for achieving optimal retention and marginal integrity. While dental resin cements are commonly used for adhesive luting of indirect ceramic restorations, concerns exist regarding their long-term reliability due to susceptibility to degradation over time and polymerization shrinkage-related issues.

This study explores an alternative approach using a pre-heated restorative resin composite as a luting material of partial coverage restorations on upper and lower posterior teeth, aiming to address these drawbacks. It will follow a split-mouth design with 60 participants selected based on strict criteria. The preparation and delivery appointments follow specific guidelines, incorporating the Morphology Driven Preparation Technique (MDPT). Assessment at 6 months and 1 year post-delivery utilizes a modified model of USPHS criteria, evaluating retention, color match, marginal discoloration, secondary caries, anatomical form, marginal adaptation, and surface roughness.

The objectives of this clinical trial are to evaluate the clinical performance of posterior partial coverage coronal restorations utilizing two different luting systems (preheated resin-based composite versus conventional dual-cure resin cement) in a split-mouth study design.

Interventions

  • Device IPS Empress Direct
    Resin composite will be heated and used to lute a ceramic partial coverage restoration.
  • Device Bisco Duo-Link Universal
    Dual cure adhesive resin cement will be used to lute a ceramic partial coverage restoration.

Primary outcome measures

  • Clinical evaluation of the performance of restoration adaptation of posterior partial coverage ceramic restoration. [Time frame: 1 year]
  • Clinical evaluation of the presence or absence of caries adjacent to posterior partial coverage ceramic restoration. [Time frame: 1 year]
  • Clinical evaluation of the performance of marginal adaptation of posterior partial coverage ceramic restoration. [Time frame: 1 year]
  • Clinical evaluation of surface staining of posterior partial coverage ceramic restoration. [Time frame: 1 year]
  • Clinical evaluation of contact points of posterior partial coverage ceramic restoration. [Time frame: 1 year]
  • Clinical evaluation of fracture of posterior partial coverage ceramic restoration. [Time frame: 1 year]
  • Clinical evaluation of wear of posterior partial coverage ceramic restoration. [Time frame: 1 year]
  • Radiographic evaluation of the performance of restoration adaptation of posterior partial coverage ceramic restoration. [Time frame: 1 year]
  • Radiographic evaluation of the presence or absence of caries adjacent to posterior partial coverage ceramic restoration. [Time frame: 1 year]
  • Radiographic evaluation of marginal adaptation of posterior partial coverage ceramic restoration. [Time frame: 1 year]

Eligibility criteria

Inclusion criteria

  • Consenting participants.
  • Individuals aged 18 years and above with no systemic diseases that will affect their participation.
  • Teeth of healthy periodontium.
  • Teeth to be restored in normal occlusion with natural antagonist and adjacent teeth.
  • Acceptable oral hygiene characterized by no gingivitis, calculus deposit or active carious lesions.
  • Non-vital teeth will be included

Exclusion criteria

  • Heavy occlusal contacts or signs of bruxism.
  • Profound, chronic periodontitis
  • Poor oral hygiene.
  • Sustained dentin hypersensitivity.
  • Systemic disease or severe medical complications or taking anti-inflammatory, analgesic, or psychotropic drugs.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Jordan · 1 center
  • Jordan University of Science and Technology — Irbid

Publications

  • Veneziani M. Posterior indirect adhesive restorations: updated indications and the Morphology Driven Preparation Technique. Int J Esthet Dent. 2017;12(2):204-230. PMID 28653051
  • Rickman LJ, Padipatvuthikul P, Chee B. Clinical applications of preheated hybrid resin composite. Br Dent J. 2011 Jul 22;211(2):63-7. doi: 10.1038/sj.bdj.2011.571. PMID 21779058
  • Ayub KV, Santos GC Jr, Rizkalla AS, Bohay R, Pegoraro LF, Rubo JH, Santos MJ. Effect of preheating on microhardness and viscosity of 4 resin composites. J Can Dent Assoc. 2014;80:e12. PMID 24598328
  • Mundim FM, Garcia Lda F, Cruvinel DR, Lima FA, Bachmann L, Pires-de-Souza Fde C. Color stability, opacity and degree of conversion of pre-heated composites. J Dent. 2011 Jul;39 Suppl 1:e25-9. doi: 10.1016/j.jdent.2010.12.001. Epub 2010 Dec 14. PMID 21163324
  • da Costa JB, Hilton TJ, Swift EJ Jr. Critical appraisal: preheating composites. J Esthet Restor Dent. 2011 Aug;23(4):269-75. doi: 10.1111/j.1708-8240.2011.00461.x. Epub 2011 Jun 22. PMID 21806761
  • Marcondes RL, Lima VP, Barbon FJ, Isolan CP, Carvalho MA, Salvador MV, Lima AF, Moraes RR. Viscosity and thermal kinetics of 10 preheated restorative resin composites and effect of ultrasound energy on film thickness. Dent Mater. 2020 Oct;36(10):1356-1364. doi: 10.1016/j.dental.2020.08.004. Epub 2020 Sep 1. PMID 32888725
  • Patussi AFC, Ramacciato JC, da Silva JGR, Nascimento VRP, Campos DES, de Araujo Ferreira Munizz I, de Souza GM, Lima RBW. Preheating of dental composite resins: A scoping review. J Esthet Restor Dent. 2023 Jun;35(4):646-656. doi: 10.1111/jerd.12991. Epub 2022 Dec 7. PMID 36478368
  • 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 30073216

Identifiers

NCT: NCT06457737 · 20240137

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗