NCT04052490

Brief Summary

The aim of this study is to evaluate the clinical performance of two finish line designs (feather edge and rounded shoulder) in relation with two occlusal designs (flat and planar) in endodontically treated teeth restored with zirconia crowns.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2021

Completed
Last Updated

April 15, 2022

Status Verified

April 1, 2022

Enrollment Period

1.8 years

First QC Date

August 7, 2019

Last Update Submit

April 9, 2022

Conditions

Gingival Inflammation

Keywords

Zirconia,occlusal scheme,endodontically treated teeth,finishline designs.

Outcome Measures

Primary Outcomes (1)

  • clinical performance in terms of the marginal adaptation of the groups

    examination will follow the USPHS criteria.

    One-Year

Secondary Outcomes (4)

  • the fracture of the restoration

    One-year

  • marginal discoloration

    One-year

  • secondary caries

    One-year

  • gingival response

    One-year

Study Arms (3)

flat occlusal reduction with feather edge finish

EXPERIMENTAL
Other: Abutment with flat occlusal reduction with feather edge finish

flat occlusal reduction with shoulder finish line

EXPERIMENTAL
Other: Abutment with flat occlusal reduction with feather edge finish

planar occlusal reduction with shoulder finish line

NO INTERVENTION

Interventions

Abutment with flat occlusal reduction with feather edge finishOTHER

Non vital teeth require a full coverage restoration to withstand the functional stresses and prevent any further destruction of tooth/crown complex. The zirconia all-ceramic crowns yield a high flexure strength and are used as an esthetic alternative to ceramo-metallic crowns. Several studies linked the effect of preparation designs to the survival of the restoration. Others, studied the effect of the finish line geometries as deep chamfer and shoulder on the marginal integrity of restorations. The feather edge finish line is used with zirconia crowns with limited data regarding its success. However, there is no presented research dealing with the effect of finishing line designs in combination with different occlusal reduction schemes on the marginal fit of full contour zirconia crowns.

Also known as: Experimental: Abutment with flat occlusal reduction with shoulder finish line
flat occlusal reduction with feather edge finishflat occlusal reduction with shoulder finish line

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • From 21-50 years old, be able to read and sign the informed consent document.
  • Have no active periodontal or periapical diseases.
  • Psychologically and physically able to withstand conventional dental procedures.
  • Maintenance of good oral hygiene.
  • Patients with teeth problems indicated for single posterior crowns:
  • Badly decayed teeth
  • Sufficient occluso-gingival tooth height
  • Endodontically treated teeth
  • No tooth mobility or grade 1 can be accepted.
  • No furcation involvement.
  • Able to return for follow-up examinations and evaluation.

You may not qualify if:

  • Patients with defective root canal treatment
  • Patient with active resistant periodontal diseases
  • Patients with poor oral hygiene and uncooperative patients
  • Pregnant women
  • Patients in the growth stage with partially erupted teeth
  • Psychiatric problems or unrealistic expectations
  • Lack of opposing dentition in the area of interest
  • Patients with bruxism.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Cairo university

Cairo, Manial, 17928, Egypt

Location

MeSH Terms

Conditions

GingivitisTooth, Nonvital

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesDental Pulp DiseasesTooth Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

August 7, 2019

First Posted

August 9, 2019

Study Start

October 1, 2019

Primary Completion

July 31, 2021

Study Completion

October 1, 2021

Last Updated

April 15, 2022

Record last verified: 2022-04

Locations

EG(1)