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Completed

NCT Number: NCT04879498

Clinical Evaluation of Monolithic Zirconia FPDs

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.

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Key information

Conditions

Dental Materials

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Monolithic zirconia

Drug

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

Other names: Zenostar T; Wieland Dental

Veneered zirconia

Other

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

Other names: IPS e.max ZirCAD

Metal-ceramic

Other

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

Primary outcomes

  1. 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 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. 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 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. Quality of restorations at 2 years

    Time frame: 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

  4. Quality of restorations at 3 years

    Time frame: 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).

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. Margin stability at baseline

    Time frame: Baseline

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

  14. Margin stability at 1 year

    Time frame: 1 year

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

  15. Margin stability at 2 years

    Time frame: 2 years

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

  16. Margin stability at 3 years

    Time frame: 3 years

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

  17. Probing depth at baseline

    Time frame: Baseline

    Probing depth of the abutment and control teeth. A score of 0 to 4 was assigned. Higher score means a worse outcome

  18. Probing depth at 1 year

    Time frame: 1 year

    Probing depth of the abutment and control teeth. A score of 0 to 4 was assigned. Higher score means a worse outcome

  19. Probing depth at 2 years

    Time frame: 2 years

    Probing depth of the abutment and control teeth. A score of 0 to 4 was assigned. Higher score means a worse outcome

  20. Probing depth at 3 years

    Time frame: 3 years

    Probing depth of the abutment and control teeth. A score of 0 to 4 was assigned. Higher score means a worse outcome

  21. Patient satisfaction at 3 years

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Collaborators

  • Ivoclar Vivadent AG

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2019
Study completion
2022
First posted
May 10, 2021
Registry last updated
Jan 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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