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

NCT ID: NCT07284680

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-19

Study Completion Date

2025-12-30

Brief Summary

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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

1. 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
2. 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

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Conditions

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Implant Assesment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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bioimolant

bioimplant assessement

Group Type EXPERIMENTAL

Implant

Intervention Type DEVICE

construction of prothesis related to bioimplant or conventional implant

screw type conventional implant

conventional screw type implant assessement

Group Type EXPERIMENTAL

Implant

Intervention Type DEVICE

construction of prothesis related to bioimplant or conventional implant

Interventions

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Implant

construction of prothesis related to bioimplant or conventional implant

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University

OTHER

Sponsor Role lead

Responsible Party

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Hosam eldin Hegazy Mohamed Ebrahim Eid

postgrad student (master of prosthodontics)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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A11061222

Identifier Type: -

Identifier Source: org_study_id