Radiographic and Histological Evaluation of Regenerated B... | NCT04324697

Studies
Radiographic and Histological Evaluation of Regenerated Bone After Grafting Using Allograft Shell and Autogenous Chips

NCT04324697

Sponsor

October 6 University

Status

Completed

Last Update Posted

Jun 9, 2020Actual

Enrollment

10Actual

Phase

Phase 4

Conditions

Alveolar Bone Resorption

Interventions

Horizontal alveolar bone augmentation

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 8, 2018Actual

Primary Completion Date

Jul 1, 2019Actual

Completion Date

Sep 5, 2019Actual

First Submitted Date

Mar 23, 2020

First Submission Date that Met QC Criteria

Mar 25, 2020

First Posted Date

Mar 27, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 6, 2020

Last Update Posted Date

Jun 9, 2020Actual

Name	Class
Ain Shams University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The clinical cases in the present study described the khoury shell technique using an allograft plate and autogenous chips, for horizontal reconstruction of the anterior alveolar ridge in the esthetic zone. Without need to use autogenous bone graft techniques that are characterized by more aggressive surgery.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Horizontal alveolar bone augmentation	Procedure	Horizontal augmentation in anterior maxilla using allograft shell and autogenous chips with no need for a second surgical site		MAXGRAFT@Cortico - Botiss

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Alveolar Bone quantity	Alveolar bone width by millimeters using Cone Beam Computed Tomography	6 months

Secondary Outcomes

Measure	Description	Time Frame
Alveolar Bone quality	Histological evaluation of status of regenerated bone vitality and remodeling	7 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with class IV of Cawood and Howell classification in the anterior maxilla.
Males and females 18-50 years of age.
Patients with adequate oral hygiene.
Patients with healed sites for at least 6 months after tooth extraction.
Patients with an inter-arch distance of at least 6 mm.
Compliance with all requirements in the study and signing the informed consent.

Exclusion Criteria:

Patients with diseases of the immune system or systemic disease affecting bone healing
Patients who are chronic users of medications known to affect the periodontal status.
Patients with history of intravenous and/or oral bisphosphonate use.
Pathologic lesions or acute infection in the area of defect.
Patients who are pregnant or lactating mothers.
Heavy smokers who smoke more than 10 cigarettes a day.
Patients with poor oral hygiene that are not amenable to motivation and improvement.
Patients with history of irradiation of the head and neck region.
Vulnerable patients.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Faculty of Dentistry Ain Shams University		Cairo		11566	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Model Description

Reconstruction of the localized deficient anterior maxilla using an allograft cortical bone plate, which was fixed at a distance from the alveolar ridge using two micro-screws, and the created gap between the allograft plate and the alveolar ridge was filled with autogenous cortical bone chips harvested intraorally using a bone scrapper.