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

March 13, 2025 updated by: King Abdullah University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Jordan
      • Irbid, Jordan, 21110
        • Recruiting
        • Jordan University of Science and Technology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Preheated resin composite (IPS Empress Direct) group
Endodontically treated teeth will be prepared to receive partial coverage ceramic restorations that will be luted with preheated composite.
Device: IPS Empress Direct
Resin composite will be heated and used to lute a ceramic partial coverage restoration.
Other Names:
  • Ivoclar Vivadent, Schaan, Liechtenstein
Experimental: Dual-cure adhesive resin cement (Bisco Duo-Link Universal) group
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
Dual cure adhesive resin cement will be used to lute a ceramic partial coverage restoration.
Other Names:
  • Bisco, USA

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical evaluation of the performance of restoration adaptation of posterior partial coverage ceramic restoration.
Time Frame: 1 year

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.
Time Frame: 1 year

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.
Time Frame: 1 year

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.
Time Frame: 1 year

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.
Time Frame: 1 year

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.
Time Frame: 1 year

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.
Time Frame: 1 year

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.
Time Frame: 1 year

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.
Time Frame: 1 year

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.
Time Frame: 1 year

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King Abdullah University Hospital

Investigators

  • Principal Investigator: Zakereyya SM Albashaireh, PhD, Jordan University of Science and Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Estimated)

November 1, 2025

Study Completion (Estimated)

February 28, 2026

Study Registration Dates

First Submitted

June 3, 2024

First Submitted That Met QC Criteria

June 9, 2024

First Posted (Actual)

June 13, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 13, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20240137

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

A consent has to be obtained from the faculty of graduate studies for sharing data as data form part of graduate students thesis.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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