NCT05252689

Brief Summary

It has been demonstrated that a great amount of tooth structure is lost during the prosthetic preparations of abutments for full-coverage FDPs with tooth substance removal of 63% of 73%, this aggressive loss of tooth structure usually accompanied with pain and post-operative sensitivity. In comparison with the vertical preparation technique, there is less amount of tooth substance loss. this clinical study will provide benefits for practitioners and clinicians by guiding them to choose a more conservative treatment plan with the better marginal fit, clinical performance and satisfaction for the patients on the long term. rather than other benefits like less chair time, less risk for pulp injury, less time and cost

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2020

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

Study Start

First participant enrolled

March 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 14, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 23, 2022

Completed
Last Updated

April 26, 2022

Status Verified

April 1, 2022

Enrollment Period

1 year

First QC Date

February 14, 2022

Last Update Submit

April 19, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Marginal adaptation

    Assessed using the modified usphs criteria by Discrete (scores) Alpha (A) No visible evidences of crevice along the margins; no catch or penetration of the explorer. Bravo (B) Visible evidence of crevice and/or catch of explorer; no penetration of the explorer. Charlie (C) Visible evidence of crevice and penetration of the explorer.

    1 year

Secondary Outcomes (3)

  • Fracture of the restoration

    1 year

  • gingival inflammation

    1 year

  • Recurrent caries

    1 year

Other Outcomes (1)

  • Patient satisfaction

    1 year

Study Arms (2)

monolithic zirconia single posterior crowns with deep chamfer finish line

ACTIVE COMPARATOR

monolithic zirconia single posterior crowns with deep chamfer finish line fabricated by cad cam machine and cemented by self adhesive resin cement.

Other: monolithic zirconia single posterior crowns with deep chamfer finish line

monolithic zirconia single posterior crowns with vertical finish line

EXPERIMENTAL

monolithic zirconia single posterior crowns with vertical finish line fabricated by cad cam machine and cemented by self adhesive resin cement.

Other: monolithic zirconia single posterior crowns with vertical finish line

Interventions

deep chamfer of 1 mm average thickness for cervical finish line, a convergence angle of 6-12° on each side and up to 20° total, in some studies, is acceptable and occlusal reduction of 1,5-2 mm

monolithic zirconia single posterior crowns with deep chamfer finish line

using special round-ended 2 degrees tapered diamond burs a non-working tip (batt bur). It has coronal diameter of 1.2 mm, apical diameter of 0.7 mm, and non- cutting end of 1 mm, which reduces or avoids damage to the connective attachment and allows a tooth-guided preparation procedure

monolithic zirconia single posterior crowns with vertical finish line

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • The patients in this study will be in the range of 18-50 years
  • Have no active periodontal or pulpal diseases, have teeth with good restorations
  • Psychologically and physically able to withstand conventional dental procedures
  • Able to return for follow-up examinations and evaluation
  • No tooth mobility or grade 1 can be accepted
  • Patients with teeth problems indicated for single posterior crowns:
  • Badly decayed teeth
  • Teeth restored with large filling restorations
  • Endodontically treated teeth
  • Malformed teeth
  • Malposed teeth (Tilted, over-erupted, rotated, etc.)
  • Spacing between posterior teeth

You may not qualify if:

  • Patients under the age of 18 or being incapable of taking out a contract
  • Patient with active resistant periodontal diseases
  • Patients with any medical condition that impaired correct oral hygiene
  • a conspicuous medical or psychological history
  • bruxism, or known allergic reaction to the materials used.
  • pregnant female patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, Egypt

Location

MeSH Terms

Conditions

Tooth, NonvitalDental Caries

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic DiseasesTooth Demineralization

Study Officials

  • Maha Taymour, PhD

    Cairo University

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

February 14, 2022

First Posted

February 23, 2022

Study Start

March 1, 2020

Primary Completion

March 1, 2021

Study Completion

July 1, 2021

Last Updated

April 26, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations