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

Unsatisfactory or Defective Restoration of Tooth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06457737
• Other study ID #: 20240137
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: February 28, 2026

Study information

• Verified date: June 2024
• Source: King Abdullah University Hospital
• Contact: Zakereyya SM Albashaireh, PhD
• Phone: 0791015505
• Email: albashai[@]just.edu.jo
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: February 28, 2026
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Unsatisfactory or Defective Restoration of Tooth

Intervention

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

Locations

Country	Name	City	State
Jordan	Jordan University of Science and Technology	Irbid

Sponsors (1)

Lead Sponsor	Collaborator
King Abdullah University Hospital

Country where clinical trial is conducted

Jordan, 

References & Publications (15)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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

External 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]