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

Dental Materials Clinical Trial

— Cerasmart  

Official title:

Clinical Evaluation of Cerasmart Implant-supported Posterior Crowns

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04995458
• Other study ID #: GC Europe N.V-4156360
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 5, 2017
• Est. completion date: June 20, 2023

Study information

• Verified date: January 2023
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: June 20, 2023
• Est. primary completion date: July 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 75 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• unacceptable oral hygiene

• bruxism

Related Conditions & MeSH terms

• Dental Materials

Intervention

Procedure:
• composite-ceramic
To assess the clinical performance of composite-ceramic crowns
• Monolithic zirconia
To assess the clinical performance of monolithic z¡irconia crowns

Locations

Country	Name	City	State
Spain	Faculty of Odontology	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid	GC Europe

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Probing depth at baseline	Probing depth of the abutment. A score of 0 to 4 was assigned. Higher score means a worse outcome	Baseline
Primary	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
Primary	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
Primary	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