Bio-implant Root Analogue Versus Conventional Screw-type... | NCT07284680

Studies
Bio-implant Root Analogue Versus Conventional Screw-type Implant for Management of Pier Abutment in Mandibular Distal Extension Cases

NCT07284680

Sponsor

Mansoura University

Status

Active, not recruiting

Last Update Posted

Dec 16, 2025Actual

Enrollment

8Actual

Phase

Not Applicable

Conditions

Implant Assesment

Interventions

Implant

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

Dec 2025

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 19, 2022Actual

Primary Completion Date

Dec 30, 2025Estimated

Completion Date

Dec 30, 2025Estimated

First Submitted Date

Nov 23, 2025

First Submission Date that Met QC Criteria

Dec 14, 2025

First Posted Date

Dec 16, 2025Actual

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

Dec 14, 2025

Last Update Posted Date

Dec 16, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hosam eldin Hegazy Mohamed Ebrahim Eid, postgrad student (master of prosthodontics), Mansoura UniversityPrincipal Investigator

Lead Sponsor

Mansoura UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

reviewing literature was lacking for bio implant and management of pier abutment in distal extension bases for this reason the aim of this research will be to use the bio implant in the management of pier abutment cases for distal extension denture base cases Aim of the study the aim of this study was to evaluate and compare the bioimplant root analogue implant with the conventional screw type implant the evaluation was done 0,3 and 6months of definitive prosthesis insertion regarding the following

radiographic evaluation of the alveolar bone hight as related to the bio implant ,conventional screw implant , pier abutment and RPD abutments : this will be done using standardized periapical digital radiographs
soft tissue evaluatins related to the bio implant ,conventional screw implant , pier abutment and RPD abutments this will be done using : A . modified plaque index (MPI) B . modified gingival index (MGI) C . peridontal pocket depth

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

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

8Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
bioimolant	Experimental	bioimplant assessement	Device: Implant
screw type conventional implant	Experimental	conventional screw type implant assessement	Device: Implant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Implant	Device	construction of prothesis related to bioimplant or conventional implant	bioimolant screw type conventional implant

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
bone changes and soft tissue changes	peri-implant bone and soft tissue changes and abutment teeth bone and soft tissue changes changes periapical X-ray for measurement of bone changes by millimeter periodontal probe for measurement of soft tissue changes by millimeter	after 3 and 6 months of denture insertion

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The patients had bilateral mandibular free-end partially edentulous cases with a pier abutment or a planned presence of pier abutment.
The edentulous space mesial to the pier abutment has a hopeless tooth or root that was used for bio-implant insertion or conventional screw-type implants.
Healthy patients with no systemic disease that can affect the implant surgery. This was verified by medical history in addition to a report from the physician.
The patients have had dentulous maxillary jaw and mandibular free-end saddle for at least 6 months.
Class I maxillo-mandibular relationship with adequate inter-arch distance.

Exclusion Criteria:

Patients with metabolic disorders that affect osseointegration such as uncontrolled diabetes mellitus, immune disorders, and osteoporosis.
Patients with heavy smoking habit
Patients complaining of severe temporomandibular joint disorder.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mansoura University		Al Mansurah	Dakahlia Governorate	7650001	Egypt

Intervention Browse Module

MeSH Terms

ID	Term
D016254	Mutagenesis, Insertional

Ancestor Terms

ID	Term
D015202	Protein Engineering
D005818	Genetic Engineering
D005821	Genetic Techniques
D008919	Investigative Techniques

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Browse Branches

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