Back to resultsInfluence of Superstructure Material on Crestal Bone Resorption and Esthetic Outcome of Dental Implants
Primary Purpose
Single Tooth Dental Implant
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
monolithic zirconia crown
metal ceramic crown
Sponsored by
About this trial
This is an interventional treatment trial for Single Tooth Dental Implant
Eligibility Criteria
Inclusion Criteria:
- Patients above 18 years old.
- 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:
- Young patients in growth stage.
- Patients with unsuitable implantation sites (patients with major boney defects or sever bone resorption)
- Pregnant women to avoid any complication that may occur in dental office.
- Patients with uncontrolled systemic disease (hypertensive patient or uncontrolled diabetic patient)
- Psychiatric problems or unrealistic expectations.
- Multiple adjacent missing teeth.
- Patients with bad oral hygiene
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Monolithic zirconia crowns
metal ceramic crowns
Arm Description
New crown material to restore dental implants
conventional crown material for restoring dental implants
Outcomes
Primary Outcome Measures
P.E.S.
Pink aesthetic scoring system for soft tissue aesthetics
Secondary Outcome Measures
crestal bone resorption
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02937220
Brief Title
Influence of Superstructure Material on Crestal Bone Resorption and Esthetic Outcome of Dental Implants
Official Title
Influence of Superstructure Material on Crestal Bone Resorption and Esthetic Outcome of Dental Implants
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Single Tooth Dental Implant
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
34 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Monolithic zirconia crowns
Arm Type
Experimental
Arm Description
New crown material to restore dental implants
Arm Title
metal ceramic crowns
Arm Type
Active Comparator
Arm Description
conventional crown material for restoring dental implants
Intervention Type
Procedure
Intervention Name(s)
monolithic zirconia crown
Intervention Description
New crown material used as final restoration for dental implants
Intervention Type
Procedure
Intervention Name(s)
metal ceramic crown
Intervention Description
Conventional crown material used as final restoration for dental implants
Primary Outcome Measure Information:
Title
P.E.S.
Description
Pink aesthetic scoring system for soft tissue aesthetics
Time Frame
1 year
Secondary Outcome Measure Information:
Title
crestal bone resorption
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients above 18 years old.
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:
Young patients in growth stage.
Patients with unsuitable implantation sites (patients with major boney defects or sever bone resorption)
Pregnant women to avoid any complication that may occur in dental office.
Patients with uncontrolled systemic disease (hypertensive patient or uncontrolled diabetic patient)
Psychiatric problems or unrealistic expectations.
Multiple adjacent missing teeth.
Patients with bad oral hygiene
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Influence of Superstructure Material on Crestal Bone Resorption and Esthetic Outcome of Dental Implants
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