NCT03214549

Brief Summary

The aim of this study is to evaluate tooth sensitivity and marginal adaptation of porcelain laminates veneers prepared with modified gull wing preparation and conventional preparation.

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
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2018

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

July 3, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
1 year until next milestone

Study Start

First participant enrolled

July 13, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

July 11, 2017

Status Verified

July 1, 2017

Enrollment Period

3 months

First QC Date

July 3, 2017

Last Update Submit

July 9, 2017

Conditions

Teeth Sensitivity

Outcome Measures

Primary Outcomes (1)

  • measuring marginal adaptation of laminates veneers using stero-microscope

    marginal adaptation of laminates veneers will be assess as follows, before laminates cementation, an impression material will be placed in the fitting surface of the veneers and placed over the reduced tooth using finger pressure, after material set the impression replica is separated from the laminates and the replica is section and measures under stero-microscope for marginal adaptation, measurement will be performed in eight different points on the buccal and mesio-distal sections, measurement will be in micrometer.

    immediately before laminates delivery up to 4 week sfter tooth preparation

Secondary Outcomes (1)

  • measuring tooth sensitivity after tooth preparation for laminates veneers

    one week after tooth preparation

Study Arms (2)

gull wing preparation veneers

ACTIVE COMPARATOR

intervention: gull wing preparation in laminates veneers proximal margin of the preparation is placed toward the lingual .The area of the proximal margin between the contact area and the gingival papilla is placed even further to the lingual. This preparation design helps to hide the margin when the restorations are viewed from an angle.

Procedure: gull wing preparation of laminates veneers

conventional preparation veneers

ACTIVE COMPARATOR

intervention: conventional preparation in laminates veneers preparation of veneers without lingual extension of preparation in mesial and distal areas

Procedure: conventional preparation of laminates veneers

Interventions

gull wing preparation of laminates veneersPROCEDURE

preparation involving mesial and distal extension further lingualy.

Also known as: dog leg preparation of laminates veneers
gull wing preparation veneers
conventional preparation of laminates veneersPROCEDURE

preparation not involving mesial and distal extension further lingualy.

conventional preparation veneers

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • From 18-40 years old, be able to read and sign the informed consent document.
  • Be physically and psychologically able to tolerate conventional restorative Procedures.
  • Have no active periodontal or pulpal diseases, have teeth with good restorations.
  • Patients with teeth problems indicated for laminate veneer (e.g:discoloration, fracture not involve more than 50% enamel loss, mild malposition.
  • Be willing to return for follow-up examinations and evaluation.

You may not qualify if:

  • Patients in the growth stage with partially erupted teeth.
  • Patient with fractured teeth of more than 50% enamel loss.
  • Patients with poor oral hygiene and motivation.
  • Pregnant women.
  • Patient with post and core endodontically treated teeth.
  • Psychiatric problems or unrealistic expectations.
  • Lack of opposite occluding dentition in the area intended for restoration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Central Study Contacts

housham N Musa, master

CONTACT

00201068778033dr_hishamnabeel@hotmail.com

rayan R dahab, master

CONTACT

00201068775688rayanrabiedahab@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

July 3, 2017

First Posted

July 11, 2017

Study Start

July 13, 2018

Primary Completion

October 1, 2018

Study Completion

October 1, 2018

Last Updated

July 11, 2017

Record last verified: 2017-07