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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03314545
Other study ID # CEBD-CU-2017-09-32
Secondary ID
Status Not yet recruiting
Phase N/A
First received October 15, 2017
Last updated October 15, 2017
Start date December 2017
Est. completion date January 2020

Study information

Verified date October 2017
Source Cairo University
Contact mohamed Elsadek, MDS
Phone 002010052992472
Email m.elsadek@dentistry.cu.edu.eg
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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"


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 35
Est. completion date January 2020
Est. primary completion date December 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 60 Years
Eligibility 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 Design


Intervention

Procedure:
laminate veneer with coronal post
laminate veneer with coronal post
post,core and crown
post,core and crown

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
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