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Effect of Different Types Crowns on Bio Compatibility and Biological Tissue Response

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: NCT02929199
Recruitment Status : Unknown
Verified October 2016 by Esraa Mohamed Ali Mraweh, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : October 11, 2016
Last Update Posted : October 12, 2016
Information provided by (Responsible Party):
Esraa Mohamed Ali Mraweh, Cairo University

Brief Summary:
The aim of this study compare soft tissue reaction (bleeding, gingival color and texture), bacteria type and count in the gingival sulcus around the restoration margin and sulcus depth of Bio-compatible High performance polymer( Bio-Hpp) restorations to E-max regardless its popularity in the dental field.

Condition or disease Intervention/treatment Phase
Personal Satisfaction Other: All ceramic crown Other: Hybrid crown Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluation of Bio Compatibility of Bio-HPP Crown Veneered With Visio.Lign Compared to Lithium Disilicate (E-max) Crown Veneered With E-max Veneering System in Anterior Esthetic Zone (Randomized 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 A
Pressable E- max, an all ceramic crown
Other: All ceramic crown
Pressed E-Max coping veneered with E-max veneering system
Other Name: Prosthetic crown

Experimental: Group B
BIO-Hpp hybrid crown
Other: Hybrid crown
pressed Bio HPP veneered with Visio-Lign Veneering system
Other Name: Prosthetic crown

Primary Outcome Measures :
  1. change in patient satisfaction(bleeding) [ Time Frame: 3,6,9 and 12 months ]
    presence or absence of bleeding is noted in questionnaire.

Secondary Outcome Measures :
  1. Clinical biological outcome(crevice depth) [ Time Frame: before preparation, immediately after crown delivery, 3, 6, 9 and 12 months ]
    Crevice depth(mm): measured using Periodontal probe and recorded in millimeters(mm).

  2. Clinical biological outcome(Bacteria count) [ Time Frame: before preparation, immediately after crown delivery, 3, 6, 9 and 12 months ]
    Bacterial account: from the culture specimens, the number of bacteria Cells per millimeter was recorded.

Information from the National Library of Medicine

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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. Age range of patients will be 18-50 years old, able to read and sign the informed consent document.
  2. Patient will be able to physically and psychologically to tolerate conventional restorative procedures.
  3. Patients have no active periodontal or pulpal diseases, no pockets, bone defects or resorption, have teeth with good restorations.
  4. Patients with good Occlusion no para-functional habits
  5. Patient with teeth with problems indicated for full coverage restoration (e.g. mild to moderate dislocation, coronal fracture where partial coverage would lack retention, malposed or malformed teeth).
  6. Patients are willing to return for follow-up examination and evaluation.
  7. Patient with sound contralateral tooth to the selected tooth required for full coverage.
  8. 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. Patients with periodontal disease, bony defects.
  4. Pregnant women`s.
  5. Patient with psychiatric problems or unrealistic expectations.
  6. Patients have no opposing occluding dentition in the area intended for restoration.
  7. Patients with Mal Occlusion and Parafunctional habits.

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 identifier (NCT number): NCT02929199

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Contact: Esra'a Mraweh, Master 01007476355
Contact: Nora Helmy, Master 01006710080

Sponsors and Collaborators
Cairo University
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Principal Investigator: Hisham Alansary, Professor

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Responsible Party: Esraa Mohamed Ali Mraweh, assistant lecturer,Fixed Prosthodontic department,MTI University, Cairo University Identifier: NCT02929199    
Other Study ID Numbers: CEBD-CU-2016-09-218
First Posted: October 11, 2016    Key Record Dates
Last Update Posted: October 12, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No