Clinical Evaluation of Monolithic Zirconia FPDs

Dental Materials Clinical Trial

Official title:

Clinical Evaluation of Monolithic Zirconia and Metal-ceramic Posterior Fixed Partial Dentures

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04879498
• Other study ID #: 4155858 Ivoclar Vivadent AG
• Secondary ID: 15/236-E
• Status: Completed
• Phase: N/A
• Start date: January 18, 2016
• Est. completion date: December 12, 2022

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 compare the survival rates and possible biological and technical complications of metal-ceramic, veneered and monolithic zirconia posterior three-unit fixed partial dentures. The null hypothesis is that no differences would be found between the parameters studied for each type of restoration.

Description:

Ninety patients requiring at least one 3-unit Fixed partial denture (FPD) in the posterior region of the maxilla or mandible were included in this study. All subjects were recruited from the Master in Buccofacial Prostheses and Occlusion (Faculty of Odontology, University Complutense of Madrid, Spain). Before treatment, patients were informed of the study objectives, clinical procedures, materials used, advantages and possible risks of the ceramic material, and other therapeutic alternatives. Prior to the study, participants were asked to provide written informed consent. Ninety posterior FPDs were produced and allocated in parallel and randomly to either monolithic zirconia, veneered zirconia or MC restorations. The clinical procedures were performed by two experienced clinicians. All participants received oral hygiene instructions and a professional tooth cleaning prior to prosthetic treatment. The abutment teeth were prepared with a 0.8- to 1-mm-wide circumferential chamfer, an axial reduction of 1 mm and an occlusal reduction of 1.5- to 2.0-mm. A 10- to 15- degree angle of convergence was achieved for the axial walls. Tooth preparations were scanned with an intraoral scanner and the FPDs were designed using specific software. The restorations were then cemented using a resin self-adhesive cement. After cementation, occlusal contacts were evaluated, and the adjusted surfaces were polished using a porcelain polishing kit. The 90 FPDs were examined at 1week (baseline),1, 2 and 2 years by 2 researchers who were not involved in the restorative treatment.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: December 12, 2022
• Est. primary completion date: March 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• One posterior tooth (molar or premolar) to be replaced

• Vital abutments or abutments with an adequate endodontic treatment

• Abutment not crowned previously

• Periodontally healthy abutments with no signs of bone resorption or periapical disease

• Adequate occlusogingival height for an appropiate connector area of at least 9 mm2

• Stable occlusion and the presence of natural dentition in the antagonist arch.

Exclusion Criteria:

• Patients who require a Fixed Dental Prosthesis of more than three units

• Patients who present reduced crown length (less than 3 mm occlusogingival heigth)

• Poor oral hygiene, high caries activity, or active periodontal disease

Related Conditions & MeSH terms

• Dental Materials

Intervention

Drug:
• Monolithic zirconia
To assess the clinical performance and survival of posterior monolithic zirconia fixed partial dentures

Other:
• Veneered zirconia
To assess the clinical performance and survival of posterior veneered zirconia fixed partial dentures
• Metal-ceramic
To assess the clinical performance and survival of posterior metal-ceramic fixed partial dentures

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid	Ivoclar Vivadent AG

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 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 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 years	The quality of the surface and color, anatomical form and marginal integrity was assessed using the California Dental Association's 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).ty was assessed	2 years
Primary	Quality of restorations at 3 years	The quality of the surface and color, anatomical form and marginal integrity was assessed using the California Dental Association's 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	Margin stability at baseline	To assess the gingival margin stability throughout the evaluation period (subgingival, isogingival or supragingival)	Baseline
Primary	Margin stability at 1 year	To assess the gingival margin stability throughout the evaluation period (subgingival, isogingival or supragingival)	1 year
Primary	Margin stability at 2 years	To assess the gingival margin stability throughout the evaluation period (subgingival, isogingival or supragingival)	2 years
Primary	Margin stability at 3 years	To assess the gingival margin stability throughout the evaluation period (subgingival, isogingival or supragingival)	3 years
Primary	Probing depth at baseline	Probing depth of the abutment and control teeth. 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 and control teeth. A score of 0 to 4 was assigned. Higher score means a worse outcome	1 year
Primary	Probing depth at 2 years	Probing depth of the abutment and control teeth. A score of 0 to 4 was assigned. Higher score means a worse outcome	2 years
Primary	Probing depth at 3 years	Probing depth of the abutment and control teeth. A score of 0 to 4 was assigned. Higher score means a worse outcome	3 years
Primary	Patient satisfaction at 3 years	Subjective patient satisfaction using Visual analogue scale (VAS) ranged from 0 (worst possible result) to10 (best possible result). The items analyzed were: esthetics, function, comfort, overall satisfaction	3 years