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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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ClinicalTrials.gov Identifier: NCT03314545
Recruitment Status : Unknown
Verified October 2017 by Mohamed Ahmed Abdelrahman Elsadek, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : October 19, 2017
Last Update Posted : October 19, 2017
Sponsor:
Information provided by (Responsible Party):
Mohamed Ahmed Abdelrahman Elsadek, Cairo University

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"

Condition or disease Intervention/treatment Phase
Teeth, Endodontically-Treated Anterior Teeth Procedure: laminate veneer with coronal post Procedure: post,core and crown Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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"
Estimated Study Start Date : December 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

Arm Intervention/treatment
laminate veneers with coronal posts
anterior endodontically treated teeth restored with laminate veneers with coronal posts
Procedure: laminate veneer with coronal post
laminate veneer with coronal post
Other Names:
  • anterior endocrown
  • endolam
  • endolaminate

post, core and crown
anterior endodontically treated teeth restored with post, core and crown
Procedure: post,core and crown
post,core and crown




Primary Outcome Measures :
  1. Gross Fracture [ Time Frame: one year ]

    : 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 :
  1. marginal integrity [ Time Frame: one year ]
    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.

  2. marginal discoloration [ Time Frame: one year ]
    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.

  3. color match [ Time Frame: one year ]
    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.

  4. caries [ Time Frame: one year ]
    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).



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. From 18-60 years old, should be able to read and sign the consent document.
  2. Ability to tolerate the restorative procedures (physical and psychological).
  3. Patients with anterior endodontically treated teeth indicated for coronal restoration:

    1. Good oral hygiene
    2. Minimum remaining coronal tooth height of 4 mm
    3. Normal functional occlusal stresses within physiological limits.
    4. Adequate crown/root ratio
    5. No signs and symptoms related to active periapical pathosis or endodontic failure.
  4. With no active periodontal or pulpal problems.
  5. Willing to return for follow-up visits.

Exclusion Criteria:

  1. Teeth not fully erupted as in young patients.
  2. Poor oral hygiene and lack of motivation
  3. Vital teeth
  4. Psychiatric problems or unrealistic expectations
  5. Excessive parafunctional stresses and bad habits like nail biting. 11
  6. The absence of sound enamel margins for the preparation
  7. Abnormally small teeth or with structural defects in enamel. 12
  8. Tooth mobility or inadequate crown/root ratio.

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 ClinicalTrials.gov identifier (NCT number): NCT03314545


Contacts
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Contact: mohamed Elsadek, MDS 002010052992472 m.elsadek@dentistry.cu.edu.eg

Sponsors and Collaborators
Cairo University
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Responsible Party: Mohamed Ahmed Abdelrahman Elsadek, Assistant Lecturer, Cairo University
ClinicalTrials.gov Identifier: NCT03314545    
Other Study ID Numbers: CEBD-CU-2017-09-32
First Posted: October 19, 2017    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mohamed Ahmed Abdelrahman Elsadek, Cairo University:
endocrown
laminate veneer with coronal post
post and core
crown
Additional relevant MeSH terms:
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Tooth, Nonvital
Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases