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"

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 Overview

• Status: Unknown
• Conditions: Anterior Teeth; Teeth, Endodontically-Treated
• Intervention / Treatment: Procedure: laminate veneer with coronal post; Procedure: post,core and crown

• Study Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: mohamed Elsadek, MDS; Phone Number: 002010052992472; Email: m.elsadek@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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
OTHER: post, core and crown; anterior endodontically treated teeth restored with post, core and crown	Procedure: post,core and crown; post,core and crown

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	one year
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.	one year
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.	one year
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).	one year

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 1, 2017
• Primary Completion (ANTICIPATED): December 1, 2019
• Study Completion (ANTICIPATED): January 1, 2020

Study Registration Dates

• First Submitted: October 15, 2017
• First Submitted That Met QC Criteria: October 15, 2017
• First Posted (ACTUAL): October 19, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 19, 2017
• Last Update Submitted That Met QC Criteria: October 15, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: crown; endocrown; laminate veneer with coronal post; post and core
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Dental Pulp Diseases; Tooth, Nonvital
• Other Study ID Numbers: CEBD-CU-2017-09-32

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No