The Performance of Posterior Partial Coverage Coronal Restorations Luted With Two Differrent Systems.
NCT Number: NCT06457737
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Unsatisfactory or Defective Restoration of Tooth
Interventions: DEVICE: IPS Empress Direct|DEVICE: Bisco Duo-Link Universal
Sponsor: King Abdullah University Hospital
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 70
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-05-01
Completion Date: 2026-02-28
Locations: Jordan University of Science and Technology, Irbid, 21110, Jordan

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.

Primary Outcome Measures: 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|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|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|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|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|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|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|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|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|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