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

Not Applicable

• Conditions: Bone Loss; Patient Satisfaction
• Interventions: Procedure: screwmented metal frameworks

• Registration Number: NCT04722744
• Lead Sponsor: Cairo University

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.

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 Timeline

• Study First Submitted: 2021-01-20
• Study First Submitted QC: 2021-01-20
• Study First Posted: 2021-01-25
• Status Verified: 2022-03
• Study Start: 2022-03-01
• Last Update Submitted: 2022-03-11
• Last Update Posted: 2022-03-25
• Primary Completion: 2023-05
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
screwmented metal frameworks based on virtual implant position.	screwmented metal frameworks	this group will receive a CAD CAM restoration based on virtually planned implant position.
screw-retained metal frameworks based on actual implant position.	screwmented metal frameworks	this group will receive screw retained CAD CAM restoration based on actual implant position using conventional open tray impression.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Faculty of Dentistry; 🇪🇬 Cairo, Manial, Egypt