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

NCT06457737 | Recruiting

• 1 other identifier: 20240137
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Unsatisfactory or Defective Restoration of Tooth

Keywords

Endodontically treated teeth; Partial coverage; Ceramic restorations; Luting systems; Preheated composite; Dual cure adhesive resin cement

Outcome Measures

Primary Outcomes (10)

• Clinical evaluation of the performance of restoration adaptation of posterior partial coverage ceramic restoration.

  Clinical examination and evaluation of the adaptation quality of partial coverage restorations according to the United States Public Health Service (USPHS) criteria as Alpha, Beta, Charlie, Delta and Echo. Alpha score means: restoration contour is continuous with the existing anatomical margin of the tooth. Beta score means: restoration is slightly under or over contoured. Charlie score means: marginal overhang or tooth structure (dentin or enamel) is exposed. Delta score means: restoration is missing, or traumatic occlusion, or restoration causes pain.

  1 year

• Clinical evaluation of the presence or absence of caries adjacent to posterior partial coverage ceramic restoration.

  Clinical examination and evaluation of the caries presence of partial coverage restorations according to the United States Public Health Service (USPHS) criteria as Alpha, Beta. Alpha score means: No visible caries Beta score means: caries present

  1 year

• Clinical evaluation of the performance of marginal adaptation of posterior partial coverage ceramic restoration.

  Clinical examination and evaluation of the marginal adaptation quality of partial coverage restorations according to the United States Public Health Service (USPHS) criteria as Alpha, Beta, Charlie, Delta. Alpha score means: Excellent continuity at resin-enamel interface, no ledge formation, no discoloration Beta score means: Slight discoloration at resin-enamel interface; ledge at interafce. Charlie score means: Moderate discoloration at resin-enamel interface measuring 1mm or greater. Delta score means: Recurrent caries at margins.

  1 year

• Clinical evaluation of surface staining of posterior partial coverage ceramic restoration.

  Clinical examination and evaluation of the presence or absence of surface staining of partial coverage restorations according to the United States Public Health Service (USPHS) criteria as Alpha, Beta. Alpha score means: staining absent Beta score means: staining present

  1 year

• Clinical evaluation of contact points of posterior partial coverage ceramic restoration.

  Clinical examination and evaluation of the contact points quality of partial coverage restorations according to the United States Public Health Service (USPHS) criteria as Alpha, Beta. Alpha score means: contact point present Beta score means: contact point absent.

  1 year

• Clinical evaluation of fracture of posterior partial coverage ceramic restoration.

  Clinical examination and evaluation of the structural integrity endurance of partial coverage restorations according to the United States Public Health Service (USPHS) criteria as Alpha, Beta, Charlie, Delta, Echo. Alpha score means: No fracture of the restoration. Beta score means: Small chipping (1/4 of restoration) Charlie score means: Moderate chipping (1/2 of restoration) Delta score means: Severe chipping (3/4 of restoration) Echo score means: loss of the restoration.

  1 year

• Clinical evaluation of wear of posterior partial coverage ceramic restoration.

  Clinical examination and evaluation of the wear presence or absence of partial coverage restorations according to the United States Public Health Service (USPHS) criteria as Alpha, Beta. Alpha score means: absence of wear. Beta score means: wear present.

  1 year

• Radiographic evaluation of the performance of restoration adaptation of posterior partial coverage ceramic restoration.

  Radiographic examination and evaluation of the adaptation quality of partial coverage restorations according to the United States Public Health Service (USPHS) criteria as Alpha, Beta, Charlie, Delta and Echo. Alpha score means: restoration contour is continuous with the existing anatomical margin of the tooth. Beta score means: restoration is slightly under or over contoured. Charlie score means: marginal overhang or tooth structure (dentin or enamel) is exposed. Delta score means: restoration is missing.

  1 year

• Radiographic evaluation of the presence or absence of caries adjacent to posterior partial coverage ceramic restoration.

  Radiographic examination and evaluation of the caries presence of partial coverage restorations according to the United States Public Health Service (USPHS) criteria as Alpha, Beta. Alpha score means: No visible caries Beta score means: caries present

  1 year

• Radiographic evaluation of marginal adaptation of posterior partial coverage ceramic restoration.

  Radiographic examination and evaluation of the marginal adaptation quality of partial coverage restorations according to the United States Public Health Service (USPHS) criteria as Alpha, Beta, Charlie, Delta. Alpha score means: Excellent continuity at resin-enamel interface, no ledge formation, no discoloration Beta score means: Slight discoloration at resin-enamel interface; ledge at interafce. Charlie score means: Moderate discoloration at resin-enamel interface measuring 1mm or greater. Delta score means: Recurrent caries at margins.

  1 year

Study Arms (2)

Preheated resin composite (IPS Empress Direct) group

EXPERIMENTAL

Endodontically treated teeth will be prepared to receive partial coverage ceramic restorations that will be luted with preheated composite.

Device: IPS Empress Direct

Dual-cure adhesive resin cement (Bisco Duo-Link Universal) group

EXPERIMENTAL

Endodontically treated teeth will be prepared to receive partial coverage ceramic restorations that will be luted with dual-cure adhesive resin cement.

Device: Bisco Duo-Link Universal

Interventions

IPS Empress Direct DEVICE

Resin composite will be heated and used to lute a ceramic partial coverage restoration.

Also known as: Ivoclar Vivadent, Schaan, Liechtenstein

Preheated resin composite (IPS Empress Direct) group

Bisco Duo-Link Universal DEVICE

Dual cure adhesive resin cement will be used to lute a ceramic partial coverage restoration.

Also known as: Bisco, USA

Dual-cure adhesive resin cement (Bisco Duo-Link Universal) group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Abdullah University Hospital: lead

Study Sites (1)

Jordan University of Science and Technology

Irbid, 21110, Jordan

RECRUITING

Related Publications (15)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Coelho NF, Barbon FJ, Machado RG, Boscato N, Moraes RR. Response of composite resins to preheating and the resulting strengthening of luted feldspar ceramic. Dent Mater. 2019 Oct;35(10):1430-1438. doi: 10.1016/j.dental.2019.07.021. Epub 2019 Aug 3.

  PMID: 31387743 BACKGROUND

• Gresnigt MMM, Ozcan M, Carvalho M, Lazari P, Cune MS, Razavi P, Magne P. Effect of luting agent on the load to failure and accelerated-fatigue resistance of lithium disilicate laminate veneers. Dent Mater. 2017 Dec;33(12):1392-1401. doi: 10.1016/j.dental.2017.09.010. Epub 2017 Nov 1.

  PMID: 29079354 BACKGROUND

• Skapska A, Komorek Z, Cierech M, Mierzwinska-Nastalska E. Comparison of Mechanical Properties of a Self-Adhesive Composite Cement and a Heated Composite Material. Polymers (Basel). 2022 Jun 30;14(13):2686. doi: 10.3390/polym14132686.

  PMID: 35808732 BACKGROUND

• Falacho RI, Marques JA, Palma PJ, Roseiro L, Caramelo F, Ramos JC, Guerra F, Blatz MB. Luting indirect restorations with resin cements versus composite resins: Effects of preheating and ultrasound energy on film thickness. J Esthet Restor Dent. 2022 Jun;34(4):641-649. doi: 10.1111/jerd.12851. Epub 2021 Dec 13.

  PMID: 34897958 BACKGROUND

• Goujat A, Abouelleil H, Colon P, Jeannin C, Pradelle N, Seux D, Grosgogeat B. Marginal and internal fit of CAD-CAM inlay/onlay restorations: A systematic review of in vitro studies. J Prosthet Dent. 2019 Apr;121(4):590-597.e3. doi: 10.1016/j.prosdent.2018.06.006. Epub 2018 Dec 1.

  PMID: 30509548 BACKGROUND

• Schmidlin PR, Zehnder M, Schlup-Mityko C, Gohring TN. Interface evaluation after manual and ultrasonic insertion of standardized class I inlays using composite resin materials of different viscosity. Acta Odontol Scand. 2005 Aug;63(4):205-12. doi: 10.1080/00016350510019973.

  PMID: 16040442 BACKGROUND

• Magne P. Immediate dentin sealing: a fundamental procedure for indirect bonded restorations. J Esthet Restor Dent. 2005;17(3):144-54; discussion 155. doi: 10.1111/j.1708-8240.2005.tb00103.x.

  PMID: 15996383 BACKGROUND

Related Links

• ISO-4049:2019 standard: The polymer-based luting materials covered by this document are intended for use in the cementation or fixation of restorations and appliances such as inlays, onlays, veneers, crowns and bridges.
• Sealed Envelope Ltd. 2012. Power calculator for binary outcome superiority trial. \[Online\]

MeSH Terms

Conditions

Tooth, Nonvital

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Zakereyya SM Albashaireh, PhD

  Jordan University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zakereyya SM Albashaireh, PhD

CONTACT

0791015505; albashai@just.edu.jo

Khawlah Z. Albashaireh, PhD

CONTACT

0796015987; kzalbashaireh@just.edu.jo

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patients who participated in the study and the assessor of the treatment outcome do not know the type of treatment procedure received.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Split mouth study design, patients will be assigned to two different treatment protocols.

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 13, 2024
• Study Start: May 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: February 28, 2026
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

JO (1)