Back to resultsClinical Evaluation of Laminate Veneers With Coronal Post Versus Post and Core Foundation Restoration With Single Crown for Restoration of Endodontically Treated Anterior Teeth (Randomized Controlled Trial) "In-vivo Study"
Primary Purpose
Teeth, Endodontically-Treated, Anterior Teeth
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
laminate veneer with coronal post
post,core and crown
Sponsored by
About this trial
This is an interventional treatment trial for Teeth, Endodontically-Treated focused on measuring endocrown, laminate veneer with coronal post, post and core, crown
Eligibility Criteria
Inclusion Criteria:
- From 18-60 years old, should be able to read and sign the consent document.
- Ability to tolerate the restorative procedures (physical and psychological).
Patients with anterior endodontically treated teeth indicated for coronal restoration:
- Good oral hygiene
- Minimum remaining coronal tooth height of 4 mm
- Normal functional occlusal stresses within physiological limits.
- Adequate crown/root ratio
- No signs and symptoms related to active periapical pathosis or endodontic failure.
- With no active periodontal or pulpal problems.
- Willing to return for follow-up visits.
Exclusion Criteria:
- Teeth not fully erupted as in young patients.
- Poor oral hygiene and lack of motivation
- Vital teeth
- Psychiatric problems or unrealistic expectations
- Excessive parafunctional stresses and bad habits like nail biting. 11
- The absence of sound enamel margins for the preparation
- Abnormally small teeth or with structural defects in enamel. 12
- Tooth mobility or inadequate crown/root ratio.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
laminate veneers with coronal posts
post, core and crown
Arm Description
anterior endodontically treated teeth restored with laminate veneers with coronal posts
anterior endodontically treated teeth restored with post, core and crown
Outcomes
Primary Outcome Measures
Gross Fracture
: Alpha (A),Restoration is intact and fully retained. Bravo (B), Restoration is partially retained with some portion of the restoration still intact.
Charlie (C), Restoration is completely missing.
Secondary Outcome Measures
marginal integrity
Alpha (A), Visual inspection and explorer, the explorer does not catch when drawn across the surface of the restoration toward the tooth, or, if the explorer does not catch, there is no visible crevice along the periphery of the restoration. Bravo (B), Visual inspection and explorer, the explorer catches and there is visible evidence of a crevice, which the explorer penetrates, indicating that the edge of the restoration does not adapt closely to the tooth structure. The dentin and/or the base is not exposed, and the restoration is not mobile. Charlie (C), Explorer, the explorer penetrates crevice defect extended to the dentino-enamel junction.
marginal discoloration
Alpha (A) Visual inspection, There is no visual evidence of marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure. Bravo (B), Visual inspection, There is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration, but the discoloration has not penetrated along the restoration in a pulpal direction. Charlie (C), Visual inspection, there is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration that has penetrated along the restoration in a pulpal direction.
color match
Alpha (A) Visual inspection The restoration appears to match the shade and translucency of adjacent tooth tissues. Bravo (B), Visual inspection, the restoration does not match the shade and translucency of adjacent tooth tissues, but the mismatch is within the normal range of tooth shades. (Within normal range: Similar to silicate cement restorations for which the dentist did not quite succeed in matching tooth color by his choice among available silicate cement shades.) Charlie (C), visual inspection , the restoration does not match the shade and translucency of the adjacent tooth structure, and the mismatch is outside the normal range of tooth shades and translucency.
caries
Alpha (A) Visual inspection, the restoration is a continuation of existing anatomic form adjacent to the restoration. Bravo (B), Visual inspection, there is visual evidence of dark deep discoloration adjacent to the restoration (but not directly associated with cavosurface margins).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03314545
Brief Title
Clinical Evaluation of Laminate Veneers With Coronal Post Versus Post and Core Foundation Restoration With Single Crown for Restoration of Endodontically Treated Anterior Teeth (Randomized Controlled Trial) "In-vivo Study"
Official Title
Clinical Evaluation of Laminate Veneers With Coronal Post Versus Post and Core Foundation Restoration With Single Crown for Restoration of Endodontically Treated Anterior Teeth (Randomized Controlled Trial) "In-vivo Study"
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2017 (Anticipated)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
January 2020 (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
Yes
5. Study Description
Brief Summary
Clinical evaluation of Laminate veneers with coronal post versus post and core foundation restoration with single crown for restoration of endodontically treated anterior teeth (Randomized Controlled Trial) "In-vivo Study"
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Teeth, Endodontically-Treated, Anterior Teeth
Keywords
endocrown, laminate veneer with coronal post, post and core, crown
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
35 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
laminate veneers with coronal posts
Arm Type
Other
Arm Description
anterior endodontically treated teeth restored with laminate veneers with coronal posts
Arm Title
post, core and crown
Arm Type
Other
Arm Description
anterior endodontically treated teeth restored with post, core and crown
Intervention Type
Procedure
Intervention Name(s)
laminate veneer with coronal post
Other Intervention Name(s)
anterior endocrown, endolam, endolaminate
Intervention Description
laminate veneer with coronal post
Intervention Type
Procedure
Intervention Name(s)
post,core and crown
Intervention Description
post,core and crown
Primary Outcome Measure Information:
Title
Gross Fracture
Description
: Alpha (A),Restoration is intact and fully retained. Bravo (B), Restoration is partially retained with some portion of the restoration still intact.
Charlie (C), Restoration is completely missing.
Time Frame
one year
Secondary Outcome Measure Information:
Title
marginal integrity
Description
Alpha (A), Visual inspection and explorer, the explorer does not catch when drawn across the surface of the restoration toward the tooth, or, if the explorer does not catch, there is no visible crevice along the periphery of the restoration. Bravo (B), Visual inspection and explorer, the explorer catches and there is visible evidence of a crevice, which the explorer penetrates, indicating that the edge of the restoration does not adapt closely to the tooth structure. The dentin and/or the base is not exposed, and the restoration is not mobile. Charlie (C), Explorer, the explorer penetrates crevice defect extended to the dentino-enamel junction.
Time Frame
one year
Title
marginal discoloration
Description
Alpha (A) Visual inspection, There is no visual evidence of marginal discoloration different from the color of the restorative material and from the color of the adjacent tooth structure. Bravo (B), Visual inspection, There is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration, but the discoloration has not penetrated along the restoration in a pulpal direction. Charlie (C), Visual inspection, there is visual evidence of marginal discoloration at the junction of the tooth structure and the restoration that has penetrated along the restoration in a pulpal direction.
Time Frame
one year
Title
color match
Description
Alpha (A) Visual inspection The restoration appears to match the shade and translucency of adjacent tooth tissues. Bravo (B), Visual inspection, the restoration does not match the shade and translucency of adjacent tooth tissues, but the mismatch is within the normal range of tooth shades. (Within normal range: Similar to silicate cement restorations for which the dentist did not quite succeed in matching tooth color by his choice among available silicate cement shades.) Charlie (C), visual inspection , the restoration does not match the shade and translucency of the adjacent tooth structure, and the mismatch is outside the normal range of tooth shades and translucency.
Time Frame
one year
Title
caries
Description
Alpha (A) Visual inspection, the restoration is a continuation of existing anatomic form adjacent to the restoration. Bravo (B), Visual inspection, there is visual evidence of dark deep discoloration adjacent to the restoration (but not directly associated with cavosurface margins).
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
From 18-60 years old, should be able to read and sign the consent document.
Ability to tolerate the restorative procedures (physical and psychological).
Patients with anterior endodontically treated teeth indicated for coronal restoration:
Good oral hygiene
Minimum remaining coronal tooth height of 4 mm
Normal functional occlusal stresses within physiological limits.
Adequate crown/root ratio
No signs and symptoms related to active periapical pathosis or endodontic failure.
With no active periodontal or pulpal problems.
Willing to return for follow-up visits.
Exclusion Criteria:
Teeth not fully erupted as in young patients.
Poor oral hygiene and lack of motivation
Vital teeth
Psychiatric problems or unrealistic expectations
Excessive parafunctional stresses and bad habits like nail biting. 11
The absence of sound enamel margins for the preparation
Abnormally small teeth or with structural defects in enamel. 12
Tooth mobility or inadequate crown/root ratio.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
mohamed Elsadek, MDS
Phone
002010052992472
Email
m.elsadek@dentistry.cu.edu.eg
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Evaluation of Laminate Veneers With Coronal Post Versus Post and Core Foundation Restoration With Single Crown for Restoration of Endodontically Treated Anterior Teeth (Randomized Controlled Trial) "In-vivo Study"
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