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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
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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