Clinical trial NCT06457737: The Performance of Posterior Partial Coverage Coronal Restorations Luted With Two Differrent Systems.
Official title: The Performance of Posterior Partial Coverage Coronal Restorations Cemented Using Two Different Luting Systems. A Comparative Clinical Trial.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Unsatisfactory or Defective Restoration of Tooth
Keywords: Endodontically treated teeth
Partial coverage
Ceramic restorations
Luting systems
Preheated composite
Dual cure adhesive resin cement
Lead sponsor: King Abdullah University Hospital
Sponsor class: OTHER
First posted: 2024-06-13
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Split mouth study design, patients will be assigned to two different treatment protocols.
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Clinical evaluation of the performance of restoration adaptation of posterior partial coverage ceramic restoration.
timeFrame: 1 year
measure: Clinical evaluation of the presence or absence of caries adjacent to posterior partial coverage ceramic restoration.
timeFrame: 1 year
measure: Clinical evaluation of the performance of marginal adaptation of posterior partial coverage ceramic restoration.
timeFrame: 1 year
measure: Clinical evaluation of surface staining of posterior partial coverage ceramic restoration.
timeFrame: 1 year
measure: Clinical evaluation of contact points of posterior partial coverage ceramic restoration.
timeFrame: 1 year
measure: Clinical evaluation of fracture of posterior partial coverage ceramic restoration.
timeFrame: 1 year
measure: Clinical evaluation of wear of posterior partial coverage ceramic restoration.
timeFrame: 1 year
measure: Radiographic evaluation of the performance of restoration adaptation of posterior partial coverage ceramic restoration.
timeFrame: 1 year
measure: Radiographic evaluation of the presence or absence of caries adjacent to posterior partial coverage ceramic restoration.
timeFrame: 1 year
measure: Radiographic evaluation of marginal adaptation of posterior partial coverage ceramic restoration.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Irbid
country: Jordan
facility: Jordan University of Science and Technology
Study officials:
affiliation: Jordan University of Science and Technology
name: Zakereyya SM Albashaireh, PhD
role: PRINCIPAL_INVESTIGATOR
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