Health TrialsbyHealthPanel

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

ConditionUnsatisfactory or Defective Restoration of Tooth
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorKing Abdullah University Hospital

About this 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Heavy occlusal contacts or signs of bruxism.

Profound, chronic periodontitis

Poor oral hygiene.

Sustained dentin hypersensitivity.

Trial design

Design model

Parallel

Treatments tested in this trial

  • IPS Empress Direct

    Device

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

  • Bisco Duo-Link Universal

    Device

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

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Preheated resin composite (IPS Empress Direct) groupExperimental treatment 1 intervention
Group B: Dual-cure adhesive resin cement (Bisco Duo-Link Universal) groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 year
2

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

Time frame
1 year
3

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.

Time frame
1 year
4

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

Time frame
1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

King Abdullah University Hospital

Lead sponsor

Source ClinicalTrials.gov
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