Marginal Bone Changes of CAD/CAM Implant Supported Screw-retained and Screw-mented Metal Frameworks

NCT ID: NCT04722744

Last Updated: 2022-03-25

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-01

Study Completion Date

2023-06-30

Brief Summary

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compare CAD/CAM implant supported screw-retained metal frameworks based on actual versus screw-mented ones based on virtual implant position regarding marginal bone changes.

Detailed Description

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patients with at least three missing teeth will be recruited and randomly assigned into two parallel groups. both groups will receive three implants based on planned implant positions and then one group will receive screw retained CAD CAM restoration with conventional impression technique while the second group will receive screw-mented CAD CAM restoration based on planned implant positions.

Conditions

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Patient Satisfaction Bone Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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screwmented metal frameworks based on virtual implant position.

this group will receive a CAD CAM restoration based on virtually planned implant position.

Group Type EXPERIMENTAL

screwmented metal frameworks

Intervention Type PROCEDURE

Intervention group: in which the edentulous area will be restored with 3-implant, screwmented CAD/CAM frameworks constructed based on planned implant positions

screw-retained metal frameworks based on actual implant position.

this group will receive screw retained CAD CAM restoration based on actual implant position using conventional open tray impression.

Group Type ACTIVE_COMPARATOR

screwmented metal frameworks

Intervention Type PROCEDURE

Intervention group: in which the edentulous area will be restored with 3-implant, screwmented CAD/CAM frameworks constructed based on planned implant positions

Interventions

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screwmented metal frameworks

Intervention group: in which the edentulous area will be restored with 3-implant, screwmented CAD/CAM frameworks constructed based on planned implant positions

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Kennedy class I, II Or IV cases.
* Opposing completely dentulous, fully or partially restored dentition.
* Good oral hygiene.
* The patient should have bone for implants, minimum bone height 10 mm and minimum bone diameter should be 6 mm.
* Adequate inter arch space for restoration 15mm or more.
* Adult patients age ≥18 years

Exclusion Criteria

* any medical disorder that could complicate surgical phase or affect osteointegration. Radiation chemotherapy.
* smokers more than 10/daily.
* Uncooperative patients.
* Patients with Para-functional habits
* Patients with severe periodontal diseases.
* Patients with limited mouth opening.
* Presence of intraoral pathological lesions.
* Diabetic (HbA1c \>7.5%).
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Amr Magdy Ibrahim

assistant lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Azza Hussein, PhD

Role: STUDY_CHAIR

Professor of Prosthodontics

Mohamed ElKhashab, PhD

Role: STUDY_DIRECTOR

Lecturer of prosthodontics

Iman Radi, PhD

Role: STUDY_DIRECTOR

Professor of Prosthodontics

Locations

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Faculty of Dentistry

Cairo, Manial, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Amr Magdy, Masters

Role: CONTACT

00201285247060

Iman Radi, PhD

Role: CONTACT

Facility Contacts

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Amr Magdy, Masters

Role: primary

Iman AW Radi, PhD

Role: backup

Other Identifiers

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101120

Identifier Type: -

Identifier Source: org_study_id

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