Comparison in Marginal Adaptation Between Conventional and Gull Wing Preparation in Laminates Veneers
Primary Purpose
Teeth Sensitivity
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
gull wing preparation of laminates veneers
conventional preparation of laminates veneers
Sponsored by
About this trial
This is an interventional treatment trial for Teeth Sensitivity
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
gull wing preparation veneers
conventional preparation veneers
Arm Description
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.
intervention: conventional preparation in laminates veneers preparation of veneers without lingual extension of preparation in mesial and distal areas
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
measuring tooth sensitivity after tooth preparation for laminates veneers
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
Slight sensitivity
Moderate sensitivity
Severe pain
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03214549
Brief Title
Comparison in Marginal Adaptation Between Conventional and Gull Wing Preparation in Laminates Veneers
Official Title
Marginal Adaptation of E.Max Laminate Veneers Prepared With Modified Gull Wing Preparation and Conventional Preparation
Study Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 13, 2018 (Anticipated)
Primary Completion Date
October 1, 2018 (Anticipated)
Study Completion Date
October 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Teeth Sensitivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
38 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
gull wing preparation veneers
Arm Type
Active Comparator
Arm Description
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.
Arm Title
conventional preparation veneers
Arm Type
Active Comparator
Arm Description
intervention: conventional preparation in laminates veneers preparation of veneers without lingual extension of preparation in mesial and distal areas
Intervention Type
Procedure
Intervention Name(s)
gull wing preparation of laminates veneers
Other Intervention Name(s)
dog leg preparation of laminates veneers
Intervention Description
preparation involving mesial and distal extension further lingualy.
Intervention Type
Procedure
Intervention Name(s)
conventional preparation of laminates veneers
Intervention Description
preparation not involving mesial and distal extension further lingualy.
Primary Outcome Measure Information:
Title
measuring marginal adaptation of laminates veneers using stero-microscope
Description
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.
Time Frame
immediately before laminates delivery up to 4 week sfter tooth preparation
Secondary Outcome Measure Information:
Title
measuring tooth sensitivity after tooth preparation for laminates veneers
Description
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
Slight sensitivity
Moderate sensitivity
Severe pain
Time Frame
one week after tooth preparation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
housham N Musa, master
Phone
00201068778033
Email
dr_hishamnabeel@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
rayan R dahab, master
Phone
00201068775688
Email
rayanrabiedahab@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Comparison in Marginal Adaptation Between Conventional and Gull Wing Preparation in Laminates Veneers
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