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Horizontal Ridge Reconstruction of Atrophic Anterior Maxillary Ridges Using Customized Xenograft Bone Shell With 1 :1 Mixture of Autogenous and Xenograft Bone Particulate

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ClinicalTrials.gov Identifier: NCT04075942
Recruitment Status : Not yet recruiting
First Posted : September 3, 2019
Last Update Posted : September 3, 2019
Sponsor:
Information provided by (Responsible Party):
Manal Ahmed Hassan Ahmed, Cairo University

Brief Summary:
Using customized Xenograft bone shell with mixture of autogenous and xenograft particulate in modified cortical shell technique. by 3D printed model from The CT scans segmentation by special software

Condition or disease Intervention/treatment Phase
Atrophic Anterior Maxillary Ridges Procedure: Atrophic Anterior Maxillary Ridges Not Applicable

Detailed Description:

Using customized Xenograft bone shell by 3D printed model from The CT scans segmentation by special software ( Mimics ) . All surgeries were performed by the same surgeon .

All surgical procedures were performed under strict aseptic conditions, all patients received infiltration local anesthesia (Articaine 4% 1:100 000 epinephrine).

a midcrestal incision was made in the anterior region using No. 15 blade. A full thickness mucoperiosteal flap was raised to expose the underlying alveolar ridge. The residual remaining bone in the area was minimal, with a maximum measured ridge thickness of 3 or 4 mm. 'To reconstruct the lost alveolar bone, an xenograft bone shell approximately 1 to 2 mm thick was shaped, after 3D print the bone shell were fixed to the buccal defect, using screws . 'The space between the plate and the existing palatal bone wall was then filled using a combination of autograft bone chips and xenograft bone particles

. Periosteal releasing incision is done to obtain stress free primary closure. The flap will then be closed using interrupted 4/0 resorbable sutures. After 4 month will insert implant . After 3 month will insert final restoration which will be mostly PMF .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Horizontal Ridge Reconstruction of Atrophic Anterior Maxillary Ridges Using Customized Xenograft Bone Shell With 1 :1 Mixture of Autogenous and Xenograft Bone Particulate
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2021

Arm Intervention/treatment
Atrophic Anterior Maxillary Ridges participants
Using customized Xenograft bone shell with equal mixture of autogenous and xenograft particulate bone as a graft with the modified cortical shell technique, with atrophic anterior maxilla with less than 5 mm Bucco-lingual
Procedure: Atrophic Anterior Maxillary Ridges
Use of modified cortical shell technique grafted with customized Xenograft bone shell




Primary Outcome Measures :
  1. Bucco-lingual bone width gain. [ Time Frame: 4 months ]


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Ages Eligible for Study:   15 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • patients with atrophic Anterior Maxillary Ridges

Exclusion Criteria:

  • Heavy smokers
  • Uncontrolled diabetic patients.
  • Pregnant patients. Psychiatric patient
  • pathology related to bone.
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Responsible Party: Manal Ahmed Hassan Ahmed, Faculty of dentistry, Master degree of dental Implantology, Cairo University
ClinicalTrials.gov Identifier: NCT04075942    
Other Study ID Numbers: PER 6-3-1
First Posted: September 3, 2019    Key Record Dates
Last Update Posted: September 3, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Atrophy
Pathological Conditions, Anatomical