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Immediate Implant Placement in the Esthetic Zone With and Without Using Autogenous Mixed With Xenograft

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04096209
Recruitment Status : Not yet recruiting
First Posted : September 19, 2019
Last Update Posted : September 19, 2019
Information provided by (Responsible Party):
Sherine Osama El ebiary, Cairo University

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Badly Decayed Teeth Device: autograft mixed with xenograft bone Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 26 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)
Estimated Study Start Date : September 30, 2019
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

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
Device: autograft mixed with xenograft 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

Primary Outcome Measures :
  1. Implant stability [ Time Frame: 4-6 months ]
    implant stability will be measured using osstell

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04096209

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Contact: Sherine Osama El-Ebiary, BDS 01285594066
Contact: Mohammed Atef, PhD 01009612708

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Cairo University
Cairo, Egypt
Contact: Mohammed Atef, PhD    0201009612708   
Contact: Magdy Zarea    0201144252034   
Sponsors and Collaborators
Cairo University
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Responsible Party: Sherine Osama El ebiary, principal investigator, Cairo University Identifier: NCT04096209    
Other Study ID Numbers: CairoUimplant 2
First Posted: September 19, 2019    Key Record Dates
Last Update Posted: September 19, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases