NCT05707780

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Jan 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress87%
Jan 2023Oct 2026

First Submitted

Initial submission to the registry

January 22, 2023

Completed
3 days until next milestone

Study Start

First participant enrolled

January 25, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 1, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2026

Expected
Last Updated

February 1, 2023

Status Verified

January 1, 2023

Enrollment Period

5 months

First QC Date

January 22, 2023

Last Update Submit

January 22, 2023

Conditions

Keywords

crownsmonolithic zirconiaresin matrix ceramicclinical evaluationsurvival

Outcome Measures

Primary Outcomes (1)

  • Survival and success rates

    Survival and success rates with Kaplan Meier method

    3 years

Secondary Outcomes (21)

  • Quality of restorations at baseline

    Baseline

  • Quality of restorations at 1 year

    1 year

  • Quality of restorations at 2 years

    2 years

  • Quality of restorations at 3 years

    3 years

  • Plaque Index (PI) at baseline

    Baseline

  • +16 more secondary outcomes

Study Arms (3)

Resin-matrix ceramic

EXPERIMENTAL

To assess the survival and clinical performance of resin-matrix posterior crows in a complete digital flow

Procedure: Resin-matrix

Monolithic zirconia

ACTIVE COMPARATOR

To assess the survival and clinical performance of monolithic zirconia posterior crows in a complete digital flow

Procedure: Monolithic zirconia

Metal-ceramic

ACTIVE COMPARATOR

To assess the survival and clinical performance of metal-ceramic posterior crows in a complete digital flow

Procedure: Metal-ceramic

Interventions

Resin-matrixPROCEDURE

posterior crowns

Also known as: VarseoSmile crown
Resin-matrix ceramic

posterior crowns

Monolithic zirconia
Metal-ceramicPROCEDURE

posterior crowns

Metal-ceramic

Eligibility Criteria

Age20 Years - 80 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 abutments or abutments with sufficient endodontic treatment
  • Abutment not crowned previously
  • Periodontally healthy abutments with no signs of bone resorption or periapical disease --
  • Adequate occlusogingival height
  • Stable occlusion, and the presence of natural dentition in the antagonist arch.

You may not qualify if:

  • Patients who present reduced crown length (less than 3 mm occlusogingival height
  • Poor oral hygiene, high caries activity, active periodontal disease or bruxism.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Odontology

Madrid, 28040, Spain

RECRUITING

MeSH Terms

Interventions

Metal Ceramic Alloys

Intervention Hierarchy (Ancestors)

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

Study Officials

  • MARIA JESUS SUAREZ, PhD

    UNIVERSITY COMPLUTENSE OF MADRID

    PRINCIPAL INVESTIGATOR
  • JESUS PELAEZ, PhD

    UNIVERSITY COMPLUTENSE OF MADRID

    PRINCIPAL INVESTIGATOR

Central Study Contacts

MARIA JESUS SUAREZ, PhD

CONTACT

JESUS PELAEZ, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2023

First Posted

February 1, 2023

Study Start

January 25, 2023

Primary Completion

July 1, 2023

Study Completion (Estimated)

October 30, 2026

Last Updated

February 1, 2023

Record last verified: 2023-01

Locations