An interventional study of composite-ceramic and Monolithic zirconia in Dental Materials, sponsored by Universidad Complutense de Madrid. Status unknown at 1 site in Spain. Open to participants aged 25 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-01-25.
Sponsored by Universidad Complutense de Madrid · Not applicable, Interventional, and Treatment
The objectives of the present study are to analyze and to compare the survival rates and possible biological and technical complications arising from the use of composite-ceramic posterior implant-supported crowns with those obtained when using their counterparts prepared using monolithic zirconia restorations. The null hypothesis is that no differences would be found between the parameters studied for each type of restoration.
Eighty patients in need of posterior implant-supported crowns (n=80) were recruited from the Master of Buccofacial Prostheses and Occlusion, Faculty of Odontology, University Complutense of Madrid, Madrid, Spain. Before treatment, all participants were informed of the purpose of the study, the clinical procedures, the material to be used, and the advantages and risks of the restorations. They were asked to give their written informed consent to participate in the study.
Eighty posterior implant-supported crowns were produced and allocated in parallel an randomly to either monolithic zirconia or composite-ceramic restorations by means of a randomization list. A total of 40 implant-supported crowns were placed using monolithic zirconia and 40 composite-ceramic. The clinical procedures were performed by two experienced clinicians. Full-arch impressions were taken using addition silicone. The restorations were cemented using a resin-based cement. The occlusion was adjusted and the surfaces polished after cementing. All restorations were prepared by an experienced technician. The restorations will be examined at one week (baseline), 1, 2, and 3 years by two researchers who were not involved in the restorative treatment. Each assessor evaluated the restoration independently, and the worst assessment will be used in the event of discrepancies.
Universidad Complutense de Madrid is the lead sponsor of 200 studies on the registry; 60 are open to participants now.
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Exclusion Criteria:
To assess the clinical performance and survival of posterior composite-ceramic implant-supported crowns
Procedure: composite-ceramic
To assess the clinical performance and survival of posterior monolitihic zirconia implant-supported crowns
Procedure: Monolithic zirconia
To assess the clinical performance of composite-ceramic crowns
Also known as: Cerasmart
To assess the clinical performance of monolithic z¡irconia crowns
Quality of restorations at baseline
The quality of the surface and color, anatomical form and marginal integrity was assessed using the California Dental Association's (CDA) assessment system. Each CDA criterion was ranked on a scale of 1 to 4, where 4 = excellent, 3 = good, 2 = unacceptable (repair), and 1 = unacceptable (replacement).
Time frame: Baseline
Quality of restorations at 1 year
The quality of the surface and color, anatomical form and marginal integrity was assessed using the California Dental Association's (CDA) assessment system. Each CDA criterion was ranked on a scale of 1 to 4, where 4 = excellent, 3 = good, 2 = unacceptable (repair), and 1 = unacceptable (replacement).
Time frame: 1 year
Quality of restorations at 2 year
The quality of the surface and color, anatomical form and marginal integrity was assessed using the California Dental Association's (CDA) assessment system. Each CDA criterion was ranked on a scale of 1 to 4, where 4 = excellent, 3 = good, 2 = unacceptable (repair), and 1 = unacceptable (replacement).
Time frame: 2 years
Quality of restorations at 3 year
The quality of the surface and color, anatomical form and marginal integrity was assessed using the California Dental Association's (CDA) assessment system. Each CDA criterion was ranked on a scale of 1 to 4, where 4 = excellent, 3 = good, 2 = unacceptable (repair), and 1 = unacceptable (replacement).
Time frame: 3 years
Plaque Index (PI) at baseline
Plaque Index (PI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Time frame: baseline
Plaque Index (PI) at 1 year
Plaque Index (PI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Time frame: 1 year
Plaque Index (PI) at 2 years
Plaque Index (PI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Time frame: 2 years
Plaque Index (PI) at 3 years
Plaque Index (PI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Time frame: 3 years
Gingival Index (GI) at baseline
Gingival Index (GI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Time frame: Baseline
Gingival Index (GI) at 1 year
Gingival Index (GI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Time frame: 1 year
Gingival Index (GI) at 2 years
Gingival Index (GI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Time frame: 2 years
Gingival Index (GI) at 3 years
Gingival Index (GI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Time frame: 3 years
Probing depth at baseline
Probing depth of the abutment. A score of 0 to 4 was assigned. Higher score means a worse outcome
Time frame: Baseline
Probing depth at 1 year
Probing depth of the abutment. A score of 0 to 4 was assigned. Higher score means a worse outcome
Time frame: 1 year
Probing depth at 2 year
Probing depth of the abutment. A score of 0 to 4 was assigned. Higher score means a worse outcome
Time frame: 2 years
Probing depth at 3 year
Probing depth of the abutment teeth. A score of 0 to 4 was assigned. Higher score means a worse outcome
Time frame: 3 years
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Universidad Complutense de Madrid