SFI Bars and Milled Bars Supporting Mandibular Overdentures. Three-year Randomized Clinical Trial

NCT ID: NCT06620497

Last Updated: 2024-10-01

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

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-06

Study Completion Date

2024-06-12

Brief Summary

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The aim of this study will be to evaluate the marginal bone loss and prosthetic complications of stress-free implant (SFI) and milled bars used to assist mandibular 4-implant overdentures after 3 years

Detailed Description

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Eight edentulous participants with insufficient stability of mandibular dentures will receive 4 implants in the mandibular ridge (2 implants in the canine areas and 2 implants in the first molar areas), and then after 3 months, patients will be randomly assigned into 2 groups; 1) group 1: will include 4 participants who will receive milled bar overdentures, and 2) group 2: will include 4 participants who will receive SFI bar overdentures. For both groups, marginal bone loss will be evaluated using the standardized digital periapical films at the time of insertion, 6 months, 1 year, and 3 years after insertion. Prosthetic and mucosal complications will be evaluated after 3 years.

Conditions

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Edentulous Alveolar Ridge in Mandible

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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SFI group

Group Type EXPERIMENTAL

stress free implant bar

Intervention Type PROCEDURE

SFI bar was sectioned and adjusted on the model for more convenience and to save the time of the appointment. The bar (Cendres Metaux, Switzerland) abutments were screwed to the implant analogues.

milled bar group

Group Type ACTIVE_COMPARATOR

milled bar

Intervention Type PROCEDURE

bar abutments were attached to the analogues and scan bodies were threaded into the bar abutments. The cast was scanned using a lab scanner (Ceramill, Amann Girrbach, Germany). The milled bar was selected from the software (Exocad DentalCAD) and designed digitally to connect the implants.

Interventions

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stress free implant bar

SFI bar was sectioned and adjusted on the model for more convenience and to save the time of the appointment. The bar (Cendres Metaux, Switzerland) abutments were screwed to the implant analogues.

Intervention Type PROCEDURE

milled bar

bar abutments were attached to the analogues and scan bodies were threaded into the bar abutments. The cast was scanned using a lab scanner (Ceramill, Amann Girrbach, Germany). The milled bar was selected from the software (Exocad DentalCAD) and designed digitally to connect the implants.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* mandibular edentulous ridge

Exclusion Criteria

* severe atrophy in mandibular ridge
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fayoum University

OTHER

Sponsor Role lead

Responsible Party

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Salsabeel A Afifi, PhD

lecturer of oral medicine and periodontology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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fayoum University

Al Fayyum, , Egypt

Site Status

Countries

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Egypt

Related Links

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Other Identifiers

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2492024

Identifier Type: -

Identifier Source: org_study_id

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