- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04096209
Immediate Implant Placement in the Esthetic Zone With and Without Using Autogenous Mixed With Xenograft
The Effect on Dental Implant Stability With and Without Using 1:1 Mixture of Autogenous Bone and Anorganic Bovine Bone Minerals Particulates in Immediate Implant Placement in the Dental Esthetic Zone (A Randomized Clinical Trial)
Xenografts are graft materials derived from the inorganic portion of animal bones; the most common source is bovine the removal of the organic component are processed to remove their antigenicity, while the remaining inorganic components provide a natural matrix as well as an excellent source of calcium. The disadvantage of xenografts is that they are only osteoconductive and the resorption rate of bovine cortical bone is slow.
However leaving the jumping gap empty has been the gold standard for immediate implantation as the formed blood clot will allow bone fill in that area.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Not using a grafting material in the jumping gap was chosen as a comparator as it's the standard procedure usually applied and showed high success rates. This should allow us to assess whether the chosen grafting material would have a positive influence on the study outcomes as compared to it.
Intraoral and extraoral autologous bone grafts could be considered as the "Gold standard" pre-prosthetic dentoalveolar reconstruction of atrophic jaws with cortico-cancellous bone grafts from intraoral and/or extraoral donor sites as a predictable technique for the facilitation of dental rehabilitation of atrophic ridges, associated with high bone survival rate and long term implant success. Autogenous bone corresponds to bone graft obtained from the same individual. It is considered the gold standard for filling of bone defects since it allows (I) osseointegration: direct contact with bone tissue without fibrous tissue ; (II) osteoconduction: support to bone growth (III) osteoinduction: differentiation of mesenchymal cells of surrounding tissue (receptor site) into osteoblastic cells ; and (IV) osteogenesis: bone neoformation by osteoblastic cells present in the graft material. Although few mature osteoblasts survive to grafting, precursor cells are responsible for the osteogenic potential
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Sherine Osama El-Ebiary, BDS
- Phone Number: 01285594066
- Email: sherine.ebiary@gmail.com
Study Contact Backup
- Name: Mohammed Atef, PhD
- Phone Number: 01009612708
- Email: zokasur@gmail.com
Study Locations
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Cairo, Egypt
- Cairo University
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Contact:
- Mohammed Atef, PhD
- Phone Number: 0201009612708
- Email: zokasur@gmail.com
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Contact:
- magdy zarea
- Phone Number: 0201144252034
- Email: magdyzarea@yahoo.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age from 20-60 years
- Both sexes
- non-restorable maxillary incisors, canine and premolars
- Good oral hygiene
- Adequate bone height apical to the alveolus of the failing tooth
Exclusion Criteria:
- Systematic disease which affect osseointegration (uncontrolled diabetes, cancer, etc...)
- Bad oral hygiene
- Bruxism, clenching, deep bite, edge to edge and abnormal habits
- Non-treated periodontal diseases
- Pregnancy and smokers
- Severe infection
- Absence of labial plate of bone (Fenestration, dehiscence).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Graft-less and grafting using xenograft and autograft
Extraction of badly decayed teeth with immediate implant placement using graft-less and grafting using autogenous bone and xenograft between the implant and labial socket bone
|
Eligible patients will be randomized in equal proportions between control group (immediate implant placement without bone grafts in the jumping gap) and study group (immediate implant placement with a mixture of Xenograft and autogenous bone placed in the jumping gap). All patients will be evaluated by proper history taking and thorough clinical and radio graphical examination and assessed according to the inclusion and exclusion criteria. Patients of both groups will be subjected to Cone beam Computed tomography (CBCT). Primary impression will be taken, a study model will then be poured and then waxing up will be performed. Patients will be instructed to rinse with chlorhexidine 0.1% mouthwash. Articaine 4% (1:100,000) local anesthesia will be given to the patient. Atraumatic extraction of the tooth or remaining root using No. 15c lancet and periotome |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Implant stability
Time Frame: 4-6 months
|
implant stability will be measured using osstell
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4-6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CairoUimplant 2
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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