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

Patient Satisfaction Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04722744
• Other study ID #: 101120
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2022
• Est. completion date: June 2023

Study information

• Verified date: March 2022
• Source: Cairo University
• Contact: Amr Magdy, Masters
• Phone: 00201285247060
• Email: amr.magdy[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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%).

Related Conditions & MeSH terms

• Bone Loss
• Patient Satisfaction

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry	Cairo	Manial

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	marginal bone changes.	Using long cone paralleling technique , RINN XCP and Digora (digital periapical radiographs for standardization. the bone loss is measured in mm	6 months
Secondary	Patient satisfaction	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