NCT04943315

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 6, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 23, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 29, 2021

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2023

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

1.6 years

First QC Date

June 23, 2021

Last Update Submit

January 22, 2023

Conditions

Dental Materials

Keywords

crownsmetal-ceramicmonolithic zirconiaclinical evaluationsurvivalwear

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 (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).

    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 (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).

    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 (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 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 (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 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 (2)

Monolithic zirconia

EXPERIMENTAL

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

Procedure: Monolithic zirconia

Metal-ceramic

ACTIVE COMPARATOR

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

Procedure: Metal-ceramic

Interventions

Monolithic zirconiaPROCEDURE

posterior crowns

Also known as: Katana
Monolithic zirconia
Metal-ceramicPROCEDURE

posterior crowns

Metal-ceramic

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patients who present reduced crown length (less than 4 mm occlusogingival height).
  • Poor oral hygiene, high caries activity, or active periodontal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Odontology

Madrid, 28040, Spain

Location

MeSH Terms

Interventions

Metal Ceramic Alloys

Intervention Hierarchy (Ancestors)

AlloysMetalsInorganic ChemicalsBiomedical and Dental MaterialsDental AlloysDental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Study Officials

  • Maria J Suarez, PhD

    Universidad Complutense de Madrid

    STUDY DIRECTOR

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

June 23, 2021

First Posted

June 29, 2021

Study Start

May 6, 2019

Primary Completion

December 15, 2020

Study Completion

July 15, 2023

Last Updated

January 25, 2023

Record last verified: 2023-01

Locations

ES(1)