- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03665025
Immediate Implant Placement With Immediate Professionalization in Aesthetic Area
September 10, 2018 updated by: mohammed nashmi hammad, Cairo University
Immediate Implant Placement With Immediate Professionalization in the Maxillary Esthetic Zone Using Mixture of Allograft and Xenograft vs Xenografts to Augment the Jumping Gap
Immediate implant placement with immediate professionalization in the maxillary esthetic zone using mixture of allograft and xenograft vs xenografts to augment the jumping gap
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
Implant placement in fresh extraction sockets in conjunction with appropriate guided bone regeneration has many benefits, which ultimately affect the total treatment plan.
The immediate placement of implants provides significant advantages, including fewer surgical procedures, shorter treatment time, and improved esthetics.
The goals of osseous replacement are maintenance of contour, elimination of dead space, and reduce postoperative infection, provide good support for dental implant and enhance bony and soft tissue healing.
allograft bone has gold standard over other augment techniques including favorable bone quality and minimal bone resorption.
Study Type
Interventional
Enrollment (Anticipated)
2
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Q8
-
Kuwait, Q8, Kuwait, 00965
- Mohammed
-
-
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
20 years to 60 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Adult patients with badly broken teeth in upper esthetic zone indicated for extraction, presence of at least 4 mm of bone beyond the root apex to guarantee implant primary stability, implant placement within the alveoli confines.
- Both sexes.
- No intraoral soft and hard tissue pathology.
- No systemic condition that contraindicate implant placement.
Exclusion Criteria:
- Presence of fenestrations or dehiscence of the residual bony Walls after extraction.
- Heavy smokers more than 20 cigarettes per day .(24)
- Patients with systemic disease that may affect normal healing.
- Psychiatric problems
- Disorders to implant are related to history of radiation therapy to the head and neck neoplasia, or bone augmentation to implant site.
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: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: immediate implant placement with xenograft
Immediate implant placement with the use of xenograft as grafting material
|
immediate implant using mixed allograft and xenograft in anterior area to fill jumping area
|
|
Experimental: immediate implant using mixed allograft and xenograft
Immediate implant placement with using mixture of allograft and xenograft material
|
immediate implant using mixed allograft and xenograft in anterior area to fill jumping area
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Crestal bone loss
Time Frame: 1 year
|
Will be measured using calliper with scale(1-10mm) for evaluation of crestal bone loss around implant which are the lower values represent a better outcome.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Patient satisfaction
Time Frame: 1 year
|
Will be measured using a satisfaction table chart which divided in 4 paraments with scale from 1-4 include( pain-infection-radiography-successful implant ),the number represent (4 excellent-3 very good -2 good-1 bad)
|
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 (Anticipated)
January 1, 2019
Primary Completion (Anticipated)
January 1, 2019
Study Completion (Anticipated)
January 1, 2019
Study Registration Dates
First Submitted
September 6, 2018
First Submitted That Met QC Criteria
September 10, 2018
First Posted (Actual)
September 11, 2018
Study Record Updates
Last Update Posted (Actual)
September 12, 2018
Last Update Submitted That Met QC Criteria
September 10, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- 14422017463550
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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