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

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04722744
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
15
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: screwmented metal frameworks
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Investigator)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. marginal bone changes. [6 months]

    Using long cone paralleling technique , RINN XCP and Digora (digital periapical radiographs for standardization. the bone loss is measured in mm

Secondary Outcome Measures

  1. Patient satisfaction [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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%).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Dentistry Cairo Manial Egypt 11555

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Amr Magdy Ibrahim, assistant lecturer, Cairo University
ClinicalTrials.gov Identifier:
NCT04722744
Other Study ID Numbers:
  • 101120
First Posted:
Jan 25, 2021
Last Update Posted:
Mar 25, 2022
Last Verified:
Mar 1, 2022
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

Study Results

No Results Posted as of Mar 25, 2022