NCT04995458

Brief Summary

The objectives of the present study are to analyze and to compare the survival rates and possible biological and technical complications arising from the use of composite-ceramic posterior implant-supported crowns with those obtained when using their counterparts prepared using monolithic zirconia restorations. 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
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

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

June 5, 2017

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2019

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 9, 2021

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2023

Completed
Last Updated

January 25, 2023

Status Verified

January 1, 2023

Enrollment Period

2.1 years

First QC Date

August 2, 2021

Last Update Submit

January 22, 2023

Conditions

Dental Materials

Keywords

implant-supported crownsmonolithic zirconiacomposite-ceramicclinical evaluationsurvival

Outcome Measures

Primary Outcomes (16)

  • 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 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).

    2 years

  • Quality of restorations at 3 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 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

  • Probing depth at baseline

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

    1 year

  • Probing depth at 2 year

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

    2 years

  • Probing depth at 3 year

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

    3 years

Study Arms (2)

Composite-ceramic

EXPERIMENTAL

To assess the clinical performance and survival of posterior composite-ceramic implant-supported crowns

Procedure: composite-ceramic

Monolithic zirconia

ACTIVE COMPARATOR

To assess the clinical performance and survival of posterior monolitihic zirconia implant-supported crowns

Procedure: Monolithic zirconia

Interventions

composite-ceramicPROCEDURE

To assess the clinical performance of composite-ceramic crowns

Also known as: Cerasmart
Composite-ceramic
Monolithic zirconiaPROCEDURE

To assess the clinical performance of monolithic z¡irconia crowns

Monolithic zirconia

Eligibility Criteria

Age25 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • One posterior tooth (molar or premolar) to restore, and with opposing tooth

You may not qualify if:

  • unacceptable oral hygiene
  • bruxism

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Odontology

Madrid, 28040, Spain

Location

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

August 2, 2021

First Posted

August 9, 2021

Study Start

June 5, 2017

Primary Completion

July 20, 2019

Study Completion

June 20, 2023

Last Updated

January 25, 2023

Record last verified: 2023-01

Locations

ES(1)