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Influence of Superstructure Material on Crestal Bone Resorption and Esthetic Outcome of Dental Implants

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: NCT02937220
Recruitment Status : Unknown
Verified October 2016 by Ahmed Roshdy Radwan, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : October 18, 2016
Last Update Posted : October 18, 2016
Information provided by (Responsible Party):
Ahmed Roshdy Radwan, Cairo University

Brief Summary:
The aim of this study is to evaluate the influence of superstructure material on crestal bone resorption and esthetic outcome of dental implants in patients with single missing tooth in the aesthetic zone.

Condition or disease Intervention/treatment Phase
Single Tooth Dental Implant Procedure: monolithic zirconia crown Procedure: metal ceramic crown Not Applicable

Detailed Description:
The transfer of occlusal forces to the implant bone interface greatly influence the long term prognosis of implants and crestal bone resorption. Accordingly this study will investigate the influence of metal ceramic crowns and monolithic zirconia crowns on crestal bone resorption under loading. Also these crown materials greatly influence the final aesthetic outcome of the definitive restoration, which will be evaluated using the pink and white aesthetic scoring systems.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Influence of Superstructure Material on Crestal Bone Resorption and Esthetic Outcome of Dental Implants
Study Start Date : December 2016
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Zirconium

Arm Intervention/treatment
Experimental: Monolithic zirconia crowns
New crown material to restore dental implants
Procedure: monolithic zirconia crown
New crown material used as final restoration for dental implants

Active Comparator: metal ceramic crowns
conventional crown material for restoring dental implants
Procedure: metal ceramic crown
Conventional crown material used as final restoration for dental implants

Primary Outcome Measures :
  1. P.E.S. [ Time Frame: 1 year ]
    Pink aesthetic scoring system for soft tissue aesthetics

Secondary Outcome Measures :
  1. crestal bone resorption [ Time Frame: 1 year ]

Information from the National Library of Medicine

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

Inclusion Criteria:

  1. Patients above 18 years old.
  2. Patients able to read and sign the informed consent document. 3. Medically free patients or with controlled systemic disease.

4. Patients with good bone quality and quantity evaluated using C.B.C.T. 5. Patients willing to return for follow-up examinations and evaluation. 6. Patients having single missing recently extracted premolar tooth.

Exclusion Criteria:

  1. Young patients in growth stage.
  2. Patients with unsuitable implantation sites (patients with major boney defects or sever bone resorption)
  3. Pregnant women to avoid any complication that may occur in dental office.
  4. Patients with uncontrolled systemic disease (hypertensive patient or uncontrolled diabetic patient)
  5. Psychiatric problems or unrealistic expectations.
  6. Multiple adjacent missing teeth.
  7. Patients with bad oral hygiene
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Responsible Party: Ahmed Roshdy Radwan, Assistant lecturer, Cairo University Identifier: NCT02937220    
Other Study ID Numbers: CEBD-CU-2016-10-223
First Posted: October 18, 2016    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Bone Resorption
Bone Diseases
Musculoskeletal Diseases