NCT04355208

Brief Summary

This clincl trial will be conducted to compare theShade Evaluation of Monochromatic versus Polychromatic layering techniques in restoration of Fractured incisal angle

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable

Status
unknown

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

April 17, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 21, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

April 22, 2020

Status Verified

April 1, 2020

Enrollment Period

6 months

First QC Date

April 17, 2020

Last Update Submit

April 21, 2020

Conditions

Anterior Teeth

Outcome Measures

Primary Outcomes (1)

  • Shade matching

    shade matching using Modified USPHS Criteria and Visual inspection using Digital Photography

    immediate after restoration

Study Arms (2)

Intervention

EXPERIMENTAL

Restoration of anterior teeth using monochromatic layering technique using body shade (filtek universal from 3m

Other: (3M™ Filtek™ Universal )

comparator

ACTIVE COMPARATOR

Restoration of anterior teeth using polychromatic layering technique using Enamel and Dentin shades (filtek Z350 xt from 3m

Other: (3M™ Filtek™ Universal )

Interventions

(3M™ Filtek™ Universal )OTHER

universal nanofillers resin composite (3M™ Filtek™ Universal )

Interventioncomparator

Eligibility Criteria

Age13 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with fractured incisal angle.
  • Vital teeth.
  • Anterior Permanent teeth.
  • Good oral hygiene.
  • Co-operative patients approving to participate in the study.

You may not qualify if:

  • Non vital teeth.
  • Severe or active periodontal disease.
  • Severe medical complications.
  • Uncooperative patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
PRINCIPAL INVESTIGATOR
PI Title
Master degree studnet, Conservative Dentistry Department, Faculty of Dentistry, Cairo University

Study Record Dates

First Submitted

April 17, 2020

First Posted

April 21, 2020

Study Start

October 1, 2020

Primary Completion

April 1, 2021

Study Completion

May 1, 2021

Last Updated

April 22, 2020

Record last verified: 2020-04