Evaluation of Marginal Bone Loss After Immediate Implant Placement in Esthetic Zone Without Xenograft.
Primary Purpose
Bone Loss
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
xenograft placement .
Sponsored by
About this trial
This is an interventional other trial for Bone Loss focused on measuring immediate implant, upper esthetic zone, marginal bone loss
Eligibility Criteria
Inclusion Criteria:
- Adult patients with badly broken teeth in upper esthetic zone indicated for extraction presence of at least 4 mm of bone beyond root apex
Exclusion Criteria:
- presence of fenestrations or dehiscences of the residual bony walls after extraction heavy smokers more than 20 cigarettes per day. systemic diseases that may affect normal healing. psychiatric problems.
Sites / Locations
- Cairo UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Marginal bone loss without grafting.
marginal bone loss with xenograft.
Arm Description
immediate implant placement in upper esthetic zone.
xenograft placement (Geistlich Bio-Oss) in immediate implant placement in upper esthetic zone between the residual labial bone and implant surface.
Outcomes
Primary Outcome Measures
marginal bone loss
Evaluation of marginal bone loss after Immediate implant placement in maxillary esthetic zone with and without xenograft
Secondary Outcome Measures
patient satisfaction
measure patient satisfaction by patient satisfaction chart.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03397316
Brief Title
Evaluation of Marginal Bone Loss After Immediate Implant Placement in Esthetic Zone Without Xenograft.
Official Title
Evaluation of Marginal Bone Loss After Immediate Implant Placement in Maxillary Esthetic Zone With and Without Xenograft.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
March 15, 2018 (Anticipated)
Study Completion Date
April 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Marginal bone loss in immediate implant placement in upper esthetic zone by comparing between non grafting in immediate implant placement with xenograft placement in other side.
the study is to assess the marginal bone loss in the two techniques and compare results between them.
Detailed Description
Marginal bone loss in immediate implant placement in upper esthetic zone by comparing between non grafting in immediate implant placement with xenograft placement in other side.
the study is to assess the marginal bone loss in the two techniques and compare results between them after follow up period of 4 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Loss
Keywords
immediate implant, upper esthetic zone, marginal bone loss
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Each patient will be given a code by researcher (A.A) and the observers will be blind to which group this case belong.
Allocation
Randomized
Enrollment
8 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Marginal bone loss without grafting.
Arm Type
No Intervention
Arm Description
immediate implant placement in upper esthetic zone.
Arm Title
marginal bone loss with xenograft.
Arm Type
Active Comparator
Arm Description
xenograft placement (Geistlich Bio-Oss) in immediate implant placement in upper esthetic zone between the residual labial bone and implant surface.
Intervention Type
Procedure
Intervention Name(s)
xenograft placement .
Intervention Description
immediate implant placement in upper esthetic zone with xenograft placement between residual labial bone and implant surface.
Primary Outcome Measure Information:
Title
marginal bone loss
Description
Evaluation of marginal bone loss after Immediate implant placement in maxillary esthetic zone with and without xenograft
Time Frame
4 months
Secondary Outcome Measure Information:
Title
patient satisfaction
Description
measure patient satisfaction by patient satisfaction chart.
Time Frame
4 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Adult patients with badly broken teeth in upper esthetic zone indicated for extraction presence of at least 4 mm of bone beyond root apex
Exclusion Criteria:
presence of fenestrations or dehiscences of the residual bony walls after extraction heavy smokers more than 20 cigarettes per day. systemic diseases that may affect normal healing. psychiatric problems.
Facility Information:
Facility Name
Cairo University
City
Cairo
ZIP/Postal Code
02
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
info@dentistry.cu.edu.eg info@dentistry.cu.edu.eg
Phone
0023634965
Email
info@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name & Degree
Ahmed Alaa
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Evaluation of Marginal Bone Loss After Immediate Implant Placement in Esthetic Zone Without Xenograft.
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