NCT03321474

Brief Summary

Patient with discolored anterior teeth and need conservative restoration treated with all ceramic esthetic laminate veneers. The Patient will be satisfied with restoration mimic the surrounding natural teeth, but conventional preparation shows approximately 60% of veneer failure in form of color change and nearly 67% Fractures of laminate veneers so the modified gull wing preparation is a significant factor affecting the final esthetic especially in discolored teeth and improve fracture resistance of the restoration.

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

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

October 21, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 25, 2017

Completed
1.7 years until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

March 26, 2019

Status Verified

March 1, 2019

Enrollment Period

5 months

First QC Date

October 21, 2017

Last Update Submit

March 25, 2019

Conditions

Discolored Teeth

Outcome Measures

Primary Outcomes (1)

  • fracture of restoration

    The fracture of the restoration of the two groups will be assessed using the modified United States public health service ( USPHS) criteria

    one year

Secondary Outcomes (1)

  • color changed

    one year

Study Arms (2)

modified gull wing preparation

EXPERIMENTAL

Gullwing preparation is the inciso - proximal extension of porcelain laminates veneer margin more palatally. The preparation finished at the gingival margin and extended towards the papilla to finish the interproximal elbow preparation

Procedure: modified gull wing preparation

conventional preparation

ACTIVE COMPARATOR

In conventional preparation of veneer it circumvents the contact areas and extends palatally in the incisal third of the tooth only. The preparation thickness is defined by a 0.5 mm facial and 1.5-2.0 mm incisal reduction with the proximal finish lines placed facially to the proximal contacts Gull wing (dog leg) preparation is the inciso - proximal extension of porcelain laminates veneer margin more palatally. This preparation design helps to hide the restoration margin when viewed from an angle, especially in discoloration. The preparation thickness is defined by a 0.5 mm facial and 1.5-2.0 mm incisal reduction with the proximal finish lines The preparation finished at the gingival margin and extended towards the papilla to finish the interproximal elbow preparation.

Procedure: modified gull wing preparation

Interventions

modified gull wing preparationPROCEDURE

preparation is the inciso - proximal extension of porcelain laminates veneer margin more palatally. The preparation finished at the gingival margin and extended towards the papilla to finish the interproximal elbow preparation.

Also known as: dog leg ,dog-led -proximal extension preparation
conventional preparationmodified gull wing preparation

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age groups from 18-50-year-old
  • patients able to read and sign the informed consent.
  • patient without periodontal diseases
  • Patients indicated for laminate veneers.
  • patients Willing to return for follow -up

You may not qualify if:

  • Patients with poor oral hygiene
  • patients with endodontic ally treated teeth
  • patients with Psychiatric problems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Duzyol M, Duzyol E, Seven N. Fracture Resistance of Laminate Veneers Made with Different Cutting and Preparation Techniques. 2016;4(3):42-48. doi:10.12691/ijdsr-4-3-3.

    BACKGROUND

  • Alhekeir DF, Al-Sarhan RA, Al Mashaan AF. Porcelain laminate veneers: Clinical survey for evaluation of failure. Saudi Dent J. 2014 Apr;26(2):63-7. doi: 10.1016/j.sdentj.2014.02.003. Epub 2014 Mar 26.

    PMID: 25408598BACKGROUND

MeSH Terms

Conditions

Tooth Discoloration

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Central Study Contacts

zeinab saeed Elshamy, MDS

CONTACT

01125195692zeinab.alshamy@dentistry.cu.edu.eg

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
Assistant lecturer

Study Record Dates

First Submitted

October 21, 2017

First Posted

October 25, 2017

Study Start

July 1, 2019

Primary Completion

December 1, 2019

Study Completion

May 1, 2020

Last Updated

March 26, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share