- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02937220
Influence of Superstructure Material on Crestal Bone Resorption and Esthetic Outcome of Dental Implants
October 17, 2016 updated by: Ahmed Roshdy Radwan, Cairo University
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
34
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Monolithic zirconia crowns
New crown material to restore dental implants
|
New crown material used as final restoration for dental implants
|
Active Comparator: metal ceramic crowns
conventional crown material for restoring dental implants
|
Conventional crown material used as final restoration for dental implants
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
P.E.S.
Time Frame: 1 year
|
Pink aesthetic scoring system for soft tissue aesthetics
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
crestal bone resorption
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2016
Primary Completion (Anticipated)
December 1, 2017
Study Completion (Anticipated)
December 1, 2017
Study Registration Dates
First Submitted
October 16, 2016
First Submitted That Met QC Criteria
October 17, 2016
First Posted (Estimate)
October 18, 2016
Study Record Updates
Last Update Posted (Estimate)
October 18, 2016
Last Update Submitted That Met QC Criteria
October 17, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEBD-CU-2016-10-223
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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