Clinical Evaluation of Monolithic Zirconia FPDs

NCT04879498 | Completed

• 2 other identifiers: 4155858 Ivoclar Vivadent AG15/236-E
• Study Type: interventional
• Target: 90
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Dental Materials

Keywords

fixed partial dentures; clinical evaluation; monolithic zirconia; veneered zirconia; survival

Outcome Measures

Primary Outcomes (21)

• 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

• 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

• 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

• 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

• 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

• Margin stability at baseline

  To assess the gingival margin stability throughout the evaluation period (subgingival, isogingival or supragingival)

  Baseline

• Margin stability at 1 year

  To assess the gingival margin stability throughout the evaluation period (subgingival, isogingival or supragingival)

  1 year

• Margin stability at 2 years

  To assess the gingival margin stability throughout the evaluation period (subgingival, isogingival or supragingival)

  2 years

• Margin stability at 3 years

  To assess the gingival margin stability throughout the evaluation period (subgingival, isogingival or supragingival)

  3 years

• 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

• 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

• 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

• 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

• 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

Study Arms (3)

Monolithic zirconia

EXPERIMENTAL

Monolithic zirconia posterior 3-unit fixed partial dentures

Drug: Monolithic zirconia

Veneered zirconia

ACTIVE COMPARATOR

Veneered zirconia posterior 3-unit fixed partial dentures

Other: Veneered zirconia

Metal-ceramic

ACTIVE COMPARATOR

Metal-ceramic posterior 3-unit fixed partial dentures

Other: Metal-ceramic

Interventions

Monolithic zirconia DRUG

To assess the clinical performance and survival of posterior monolithic zirconia fixed partial dentures

Also known as: Zenostar T; Wieland Dental

Monolithic zirconia

Veneered zirconia OTHER

To assess the clinical performance and survival of posterior veneered zirconia fixed partial dentures

Also known as: IPS e.max ZirCAD

Veneered zirconia

Metal-ceramic OTHER

To assess the clinical performance and survival of posterior metal-ceramic fixed partial dentures

Metal-ceramic

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Complutense de Madrid: lead
• Ivoclar Vivadent AG: collaborator

MeSH Terms

Interventions

Metal Ceramic Alloys

Intervention Hierarchy (Ancestors)

Alloys; Metals; Inorganic Chemicals; Biomedical and Dental Materials; Dental Alloys; Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2021
• First Posted: May 10, 2021
• Study Start: January 18, 2016
• Primary Completion: March 30, 2019
• Study Completion: December 12, 2022
• Last Updated: January 25, 2023

Record last verified: 2023-01