Clinical Evaluation of Cerasmart Implant-supported Posterior Crowns
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Dental Materials
- Sponsor
- Universidad Complutense de Madrid
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Gingival Index (GI) at baseline
- Status
- Active, Not Recruiting
- Last Updated
- 3 years ago
Overview
Brief 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.
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •One posterior tooth (molar or premolar) to restore, and with opposing tooth
Exclusion Criteria
- •unacceptable oral hygiene
Outcomes
Primary Outcomes
Gingival Index (GI) at baseline
Time Frame: Baseline
Gingival Index (GI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Gingival Index (GI) at 1 year
Time Frame: 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.
Plaque Index (PI) at 1 year
Time Frame: 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.
Plaque Index (PI) at 3 years
Time Frame: 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.
Gingival Index (GI) at 3 years
Time Frame: 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.
Probing depth at baseline
Time Frame: Baseline
Probing depth of the abutment. A score of 0 to 4 was assigned. Higher score means a worse outcome
Probing depth at 3 year
Time Frame: 3 years
Probing depth of the abutment teeth. A score of 0 to 4 was assigned. Higher score means a worse outcome
Quality of restorations at 1 year
Time Frame: 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).
Plaque Index (PI) at baseline
Time Frame: baseline
Plaque Index (PI) of the abutment and control teeth. A score of 0 to 3 was assigned. Higher score means a worse outcome.
Gingival Index (GI) at 2 years
Time Frame: 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.
Probing depth at 2 year
Time Frame: 2 years
Probing depth of the abutment. A score of 0 to 4 was assigned. Higher score means a worse outcome
Quality of restorations at baseline
Time Frame: 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).
Quality of restorations at 2 year
Time Frame: 2 years
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).
Quality of restorations at 3 year
Time Frame: 3 years
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).
Plaque Index (PI) at 2 years
Time Frame: 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.
Probing depth at 1 year
Time Frame: 1 year
Probing depth of the abutment. A score of 0 to 4 was assigned. Higher score means a worse outcome