Clinical Evaluation of Composite-ceramic Implant-supported Posterior Crowns (Cerasmart) (Cerasmart)

Clinical Evaluation of Cerasmart Implant-supported Posterior Crowns

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Dental Materials
• Intervention / Treatment: Procedure: composite-ceramic; Procedure: Monolithic zirconia

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain, 28040
    • Faculty of Odontology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• One posterior tooth (molar or premolar) to restore, and with opposing tooth

Exclusion Criteria:

• unacceptable oral hygiene
• bruxism

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Composite-ceramic; To assess the clinical performance and survival of posterior composite-ceramic implant-supported crowns	Procedure: composite-ceramic; To assess the clinical performance of composite-ceramic crowns; Other Names: Cerasmart
Active Comparator: Monolithic zirconia; To assess the clinical performance and survival of posterior monolitihic zirconia implant-supported crowns	Procedure: Monolithic zirconia; To assess the clinical performance of monolithic z¡irconia crowns

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	1 year
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.	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.	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.	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.	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.	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.	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.	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.	3 years
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).	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).	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	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	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	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	3 years

Collaborators and Investigators

• Sponsor: Universidad Complutense de Madrid
• Collaborators: GC Europe
• Investigators: Study Director: MARIA J SUAREZ, PhD, Universidad Complutense de Madrid

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2017
• Primary Completion (Actual): July 20, 2019
• Study Completion (Anticipated): June 20, 2023

Study Registration Dates

• First Submitted: August 2, 2021
• First Submitted That Met QC Criteria: August 2, 2021
• First Posted (Actual): August 9, 2021

Study Record Updates

• Last Update Posted (Actual): January 25, 2023
• Last Update Submitted That Met QC Criteria: January 22, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: survival; clinical evaluation; monolithic zirconia; implant-supported crowns; composite-ceramic
• Other Study ID Numbers: GC Europe N.V-4156360

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No