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

March 11, 2022 updated by: Amr Magdy Ibrahim, Cairo University

Marginal Bone Changes of CAD/CAM Implant Supported Screw-retained Metal Frameworks Based on Actual Versus Screwmented Ones Based on Virtual Implant Position: A Randomized Clinical Stud

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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%).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: screwmented metal frameworks based on virtual implant position.
this group will receive a CAD CAM restoration based on virtually planned implant position.
Procedure: 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
Active Comparator: 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.
Procedure: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
marginal bone changes.
Time Frame: 6 months
Using long cone paralleling technique , RINN XCP and Digora (digital periapical radiographs for standardization. the bone loss is measured in mm
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: 6 months
Patient satisfaction questionnaire using Visual Analogue Scale (VAS) scale, from 0-100, where 0 is the worst meaning that patient is not satisfied and 100 is the highest satisfaction meaning the patient is totally satisfied
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Study Chair: Azza Hussein, PhD, Professor of prosthodontics
  • Study Director: Mohamed ElKhashab, PhD, Lecturer of Prosthodontics
  • Study Director: Iman Radi, PHD, Professor of prosthodontics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

January 20, 2021

First Submitted That Met QC Criteria

January 20, 2021

First Posted (Actual)

January 25, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2022

Last Update Submitted That Met QC Criteria

March 11, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • 101120

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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