Subperiosteal Implants Constructed With Digital Technology | NCT06012643

Studies
Subperiosteal Implants Constructed With Digital Technology

NCT06012643

Sponsor

Mansoura University

Status

Unknown status

Last Update Posted

Oct 23, 2023Actual

Enrollment

23Estimated

Phase

Not provided

Conditions

Alveolar Bone Loss

Interventions

The purpose of this systematic review of case reports and case series was to evaluate the spectrum of subperiosteal implants for severely atrophied jaws using digital technology.

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

Oct 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2023Actual

Primary Completion Date

Oct 20, 2023Actual

Completion Date

Oct 30, 2023Estimated

First Submitted Date

Aug 13, 2023

First Submission Date that Met QC Criteria

Aug 22, 2023

First Posted Date

Aug 25, 2023Actual

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

Oct 19, 2023

Last Update Posted Date

Oct 23, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mohamed Elsawy, lecturer, Department of prosthodontics, principle investigator, Mansoura UniversityPrincipal Investigator

Lead Sponsor

Mansoura UniversityOTHER

Collaborators

Not provided

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

Atrophied jaw is a condition where there is insufficient bone quantity to place root form implants. Several treatment plans are available for treating atrophied jaws, including subperiosteal implants. Subperiosteal implants were introduced in the last century. Poor clinical results led those implants to be progressively abandoned. Recently, several Authors suggested a revival of subperiosteal implants as an alternative to regenerative procedures.

Detailed Description

An electronic and manual search was conducted in the PubMed, Scopus, and Google Scholar databases. Publications of case reports and series written in English without data restrictions that reported on subperiosteal implants management of patients with severely atrophied jaws in completely and partially edentulous population.

The purpose of this systematic review of case reports and case series was to evaluate the spectrum of subperiosteal implants for severely atrophied jaws using digital technology.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

23Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
The purpose of this systematic review of case reports and case series was to evaluate the spectrum of subperiosteal implants for severely atrophied jaws using digital technology.	Other	An electronic and manual search was conducted in the PubMed, Scopus, and Google Scholar databases. Publications of case reports and series written in English without data restrictions

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
to evaluate the spectrum of subperiosteal implants for severely atrophied jaws using digital technology.	The outcome was implant success or rejection.	5 year retrospective

Secondary Outcomes

Measure	Description	Time Frame
Biological complications	such as (dehiscence or exposure of the framework)	5 year retrospective

Other Outcomes

Measure	Description	Time Frame
Prosthetic complications	such as (fracture of the definitive or temporary prosthesis)	5 year retrospective

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

population with partial or fully edentulous arches, in particular Cawood and Howell class (IV-VI);

Exclusion Criteria:

Articles were excluded if complex reconstructive surgery including bone grafts, barrier membranes, jaw osteotomies, sinus lift, alveolar ridge distraction, and zygomatic implants was recommended for treatment

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

85 Years

Standard Ages

ChildAdultOlder Adult

Study Population

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohammed ELSawy, PhD	Contact	00201061314522		Dr_sawy@windowslive.com
Salah A. Hegazy, PhD	Contact	00201227690209		salahhegazy@yahoo.com

Overall Officials

Name	Affiliation	Role
Mohammed ELSawy, PhD	Mansoura University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mohammed El Sawy	Recruiting	Multiple Locations		12345	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

just by contacting the corresponding author

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016301	Alveolar Bone Loss

Ancestor Terms

ID	Term
D001862	Bone Resorption
D001847	Bone Diseases
D009140	Musculoskeletal Diseases
D055093	Periodontal Atrophy

Browse Leaves

Not provided

Browse Branches

Not provided