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NCT Number: NCT06457737

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

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.

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Key information

Conditions

Unsatisfactory or Defective Restoration of Tooth Dental Pulp Diseases Stomatognathic Diseases Tooth Diseases Tooth, Nonvital

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jordan University of Science and Technology

Irbid, 21110, Jordan

Location status: Recruiting

Location contact

Zakereyya SM Albashaireh, PhD

CONTACT

[email protected]

0791015505

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IPS Empress Direct

Device

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

Other names: Ivoclar Vivadent, Schaan, Liechtenstein

Bisco Duo-Link Universal

Device

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

Other names: Bisco, USA

Primary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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

  10. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Khawlah Z. Albashaireh, PhD

CONTACT

[email protected]

0796015987

Zakereyya SM Albashaireh, PhD

CONTACT

[email protected]

0791015505

Sponsors and collaborators

Lead sponsor

King Abdullah University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Jun 13, 2024
Registry last updated
Mar 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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