Digital vs Analog Impression in Cases of All-on-4 - Prosthesis

NCT ID: NCT04475913

Last Updated: 2021-03-01

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

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-11

Study Completion Date

2020-08-20

Brief Summary

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Fifty six patients were randomly enrolled in the study. Participants were randomly stratified into two control groups and two test groups, from which conventional pick up and digital impressions were made respectively. Patients of group 1 (CIG Axial) and 3 (DIG Axial) received 4 axial implants whereas, group 2 patients (CIG Tilted), and group 4 (DIG Tilted) received two anterior axial implants and two distal tilted implants.

All participants received hybrid dentures. Bone loss, implant loss, maintenance of prosthesis were evaluated at 6m,12m, and 24 months follow up period.

Detailed Description

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Conditions

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Edentulous Mouth

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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(CIG Axial)

received 4 axial implants and conventional impression

Group Type ACTIVE_COMPARATOR

DIG Axial

Intervention Type OTHER

patients received 4 axial implants and digital impression

(DIG Axial)

received 4 axial implants and digital impression

Group Type EXPERIMENTAL

DIG Tilted

Intervention Type OTHER

received two anterior axial implants and two distal tilted implants, and digital impression

CIG Axial

Intervention Type OTHER

patients received 4 axial implants and conventional impression

CIG Tilted

received two anterior axial implants and two distal tilted implants, and conventional impression

Group Type ACTIVE_COMPARATOR

DIG Tilted

Intervention Type OTHER

received two anterior axial implants and two distal tilted implants, and digital impression

(DIG Tilted)

received two anterior axial implants and two distal tilted implants, and digital impression

Group Type EXPERIMENTAL

DIG Axial

Intervention Type OTHER

patients received 4 axial implants and digital impression

CIG Tilted

Intervention Type OTHER

received two anterior axial implants and two distal tilted implants, and conventional impression

Interventions

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DIG Axial

patients received 4 axial implants and digital impression

Intervention Type OTHER

DIG Tilted

received two anterior axial implants and two distal tilted implants, and digital impression

Intervention Type OTHER

CIG Axial

patients received 4 axial implants and conventional impression

Intervention Type OTHER

CIG Tilted

received two anterior axial implants and two distal tilted implants, and conventional impression

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* completely edentulous patients with age range from 50-65 years.
* physically and psychologically eligible participants for implants placement.
* adequate bone to receive 4 interforaminal implants.

Exclusion Criteria

participants were excluded if

* medical conditions that precludes implants placement
* smokers
* patients suffering from any parafunctional habits
Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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October University for Modern Sciences and Arts

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dina Elawady

Role: PRINCIPAL_INVESTIGATOR

Lecturer

Locations

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OctoberUMSA

Giza, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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5

Identifier Type: -

Identifier Source: org_study_id

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