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Effect of Different Types of Crowns on Patient Satisfaction and Clinical Assesment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02929173
Recruitment Status : Unknown
Verified October 2016 by Nora helmy hassaneen, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : October 11, 2016
Last Update Posted : October 11, 2016
Information provided by (Responsible Party):
Nora helmy hassaneen, Cairo University

Brief Summary:

The aim of this study is to compare the patient satisfaction and clinical assessment (shade matching, surface texture and marginal discoloration) of Bio- High Performance Polymers (HPP) restoration versus E-max restoration compared to contralateral tooth in anterior zone.

Regardless E-max popularity in the dental field.

Condition or disease Intervention/treatment Phase
Personal Satisfaction Other: Allceram Other: hybrid crown Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Patient Satisfaction and Clinical Assessment of Biocompatible High Performance Polymers Crown Veneered With Visio.Lign Versus E-max Crown Veneered With E-max Veneering System in Anterior Aesthetic Zone.(Randomized Controlled Clinical Trial)
Study Start Date : January 2017
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : March 2018

Arm Intervention/treatment
Active Comparator: Group 2
E-max is un allceram crown
Other: Allceram
Pressed E-max coping veneered with E-max veneering system
Other Name: Prosthetic Crown

Experimental: Group 1
Bio HPP crown is a hybrid crown
Other: hybrid crown
pressed Bio HPP coping veneered with visolign veneering system
Other Name: Prosthetic Crown

Primary Outcome Measures :
  1. Change in esthetic patient satisfaction [ Time Frame: At crown delivery time and after delivery 3, 6, 9, 12 month ]
    using Rating scores from 0-2 (0= Poor, 1=Accepted, 2=Excellent)

Secondary Outcome Measures :
  1. Shade match to contralateral tooth [ Time Frame: At crown delivery time and after delivery 3, 6, 9, 12 month ]
    using Modified USPHS scores from 0-3 (0= Match to contralateral tooth, 1=Acceptable mismatch to contralateral tooth , 2=Unacceptable mismatch to contralateral tooth, 3=New restoration is needed.)

  2. Marginal discolouration [ Time Frame: At crown delivery time and after delivery 3, 6, 9, 12 month ]
    using Modified USPHS scores from 0-3 (0= Smooth surface., 1=Slight staining can be polished away., 2=Gross staining., 3=New restoration is needed.)

  3. Surface texture [ Time Frame: At crown delivery time and after delivery 3, 6, 9, 12 month ]
    using Modified USPHS scores from 0-3 (0= Surface is smooth as the surrounding., 1=Surface is rough than the surrounding, 2=Gross staining., 3=Surface is very rough avoiding movement of the explorer, 4=New restoration is needed.)

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Patient will be able to physically and psychologically to tolerate conventional restorative procedures.
  2. Patients have no active periodontal or pulpal diseases, have teeth with good restorations.
  3. Patient with anterior tooth with problems indicated for full coverage restoration (e.g. mild to moderate discoloration, coronal fracture where partial coverage would lack retention, malposed or malformed teeth) Patients are willing to return for follow-up examination and evaluation.
  4. Patient with sound contralateral tooth to the selected tooth required for full coverage.
  5. Patient with root canal treated tooth requiring full coverage restoration

Exclusion Criteria:

  1. Patient in the growth stage with partially erupted teeth.
  2. Patient with poor oral hygiene and motivation.
  3. Pregnant women's.
  4. Patient with psychiatric problems or unrealistic expectations.
  5. Patients have no opposing occluding dentition in the area intended for restoration.
  6. Patients with parafunctional habits.
  7. Color blindness patients are excluded.
  8. Patient without contralateral tooth to that tooth to will be restored.
  9. Patient without adjacent teeth to that tooth will be restored.
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Responsible Party: Nora helmy hassaneen, assistant lecturer of fixed prosthodontic department,MTI university, Cairo University Identifier: NCT02929173    
Other Study ID Numbers: CEBD-CU-2016-09-217
First Posted: October 11, 2016    Key Record Dates
Last Update Posted: October 11, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No