Comparison in Marginal Adaptation Between Conventional and Gull Wing Preparation in Laminates Veneers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03214549
Recruitment Status : Not yet recruiting
First Posted : July 11, 2017
Last Update Posted : July 11, 2017
Information provided by (Responsible Party):
Housham nabiel hassan musa, Cairo University

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.

Condition or disease Intervention/treatment Phase
Teeth Sensitivity Procedure: gull wing preparation of laminates veneers Procedure: conventional preparation of laminates veneers Not Applicable

Detailed Description:

Visit 1: Preoperative records, face-to-face adherence reminder session, clinical, radio-graphic examination and primary impression for diagnostic cast construction.

Visit 2: Teeth preparation, secondary impression,temporary restoration and teeth sensitivity evaluation using United States Public Health Service criteria.

Visit 3: Placement and permanent cementation of the final restoration

Visit 4: marginal adaptation measurement by electron microscope using impression replica.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Marginal Adaptation of E.Max Laminate Veneers Prepared With Modified Gull Wing Preparation and Conventional Preparation
Estimated Study Start Date : July 13, 2018
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : October 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Active Comparator: gull wing preparation veneers
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
preparation involving mesial and distal extension further lingualy.
Other Name: dog leg preparation of laminates veneers

Active Comparator: conventional preparation veneers
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
preparation not involving mesial and distal extension further lingualy.

Primary Outcome Measures :
  1. measuring marginal adaptation of laminates veneers using stero-microscope [ Time Frame: immediately before laminates delivery up to 4 week sfter tooth preparation ]
    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.

Secondary Outcome Measures :
  1. measuring tooth sensitivity after tooth preparation for laminates veneers [ Time Frame: one week after tooth preparation ]

    measurment will be acording tomodified United States Public Health Service (USPHS) criteria used for the clinical evaluations of the restorations. post-operative sensitivity 0 No symptoms

    1. Slight sensitivity
    2. Moderate sensitivity
    3. Severe pain

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03214549

Contact: housham N Musa, master 00201068778033
Contact: rayan R dahab, master 00201068775688

Sponsors and Collaborators
Cairo University

Responsible Party: Housham nabiel hassan musa, principal investigator, Cairo University Identifier: NCT03214549     History of Changes
Other Study ID Numbers: CairoUni
First Posted: July 11, 2017    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Dentin Sensitivity
Tooth Diseases
Stomatognathic Diseases