Clinical Evaluation of Monolithic Zirconia Crowns

Sponsor
Universidad Complutense de Madrid (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04943315
Collaborator
Kuraray Co. Ltd (Other)
70
1
2
43.3
1.6

Study Details

Study Description

Brief Summary

The objectives of the present study are to compare the survival rates and possible biological and technical complications of metal-ceramic, and monolithic third-generation zirconia posterior crowns. The null hypothesis is that no differences would be found between the parameters studied for each type of restoration.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Monolithic zirconia
  • Procedure: Metal-ceramic
N/A

Detailed Description

Seventy patients requiring at least one crown 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. Seventy posterior crowns were produced and allocated in parallel and randomly to either monolithic third-generation zirconia, or metal-ceramic (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- 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 crowns 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 70 crowns were examined at 1week (baseline),1, 2 and 3 years by 2 researchers who were not involved in the restorative treatment.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Clinical Evaluation of Monolithic Zirconia and Metal-ceramic Posterior Crowns
Actual Study Start Date :
May 6, 2019
Actual Primary Completion Date :
Dec 15, 2020
Anticipated Study Completion Date :
Dec 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Monolithic zirconia

To assess the clinical performance and survival of posterior monolithic zirconia crowns

Procedure: Monolithic zirconia
posterior crowns
Other Names:
  • Katana
  • Active Comparator: Metal-ceramic

    To assess the clinical performance and survival of posterior metal-ceramic crowns

    Procedure: Metal-ceramic
    posterior crowns

    Outcome Measures

    Primary Outcome Measures

    1. Quality of restorations at baseline [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).

    2. Quality of restorations at 1 year [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).

    3. Quality of restorations at 2 years [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).

    4. Quality of restorations at 3 years [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).

    5. Plaque Index (PI) at baseline [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 [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 [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 [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 [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 [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 [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 [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 [Baseline]

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

    14. Margin stability at 1 year [1 year]

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

    15. Margin stability at 2 years [2 years]

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

    16. Margin stability at 3 years [3 years]

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

    17. Probing depth at baseline [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 [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 [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 [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 [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • One posterior tooth (molar or premolar) to be crowned

    • Vital abutment or abutment with an adequate endodontic treatment

    • Abutment not crowned previously

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

    • Adequate occlusogingival height ≥ 4 mm.

    • Stable occlusion and the presence of natural antagonist tooth.

    Exclusion Criteria:
    • Patients who present reduced crown length (less than 4 mm occlusogingival height).

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Odontology Madrid Spain 28040

    Sponsors and Collaborators

    • Universidad Complutense de Madrid
    • Kuraray Co. Ltd

    Investigators

    • Study Director: Maria J Suarez, PhD, Universidad Complutense de Madrid

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Universidad Complutense de Madrid
    ClinicalTrials.gov Identifier:
    NCT04943315
    Other Study ID Numbers:
    • University Complutense Madrid
    • 4157246
    First Posted:
    Jun 29, 2021
    Last Update Posted:
    Aug 9, 2021
    Last Verified:
    Jun 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Universidad Complutense de Madrid

    Study Results

    No Results Posted as of Aug 9, 2021