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

Sponsor

Manal Ahmed Hassan Ahmed (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04075942

Collaborator

(none)

Enrollment

Arm

Study Details

Study Description

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	N/A

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 .

Study Design

Study Type:

Interventional

Anticipated 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

Anticipated Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Jan 1, 2021

Anticipated Study Completion Date :

Jan 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: 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

Arm

Intervention/Treatment

Other: 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

Outcome Measures

Primary Outcome Measures

Bucco-lingual bone width gain. [4 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

patients with atrophic Anterior Maxillary Ridges

Exclusion Criteria:

Heavy smokers
Uncontrolled diabetic patients.
Pregnant patients. Psychiatric patient
pathology related to bone.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Manal Ahmed Hassan Ahmed

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Sep 3, 2019

Last Update Posted:

Jan 26, 2021

Last Verified:

Jan 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Atrophy

Study Results

No Results Posted as of Jan 26, 2021