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

King Abdullah University Hospital

Status: Enrolling

Conditions: Unsatisfactory or Defective Restoration of Tooth

Treatments: Device: Bisco Duo-Link Universal; Device: IPS Empress Direct

Study type: Interventional

Funder types: Other

Identifiers

NCT06457737

20240137

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

Preheated resin composite (IPS Empress Direct) group

Experimental group

Description:

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

Treatment:

Device: IPS Empress Direct

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

Experimental group

Description:

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

Treatment:

Device: Bisco Duo-Link Universal