Passive Fit of CAD/CAM Screw-retained Metal Frameworks Versus Screwmented Ones

Edentulous Clinical Trial

Official title:

Passive Fit of CAD/CAM Implant Supported Screw-retained Metal Frameworks Based on Actual Versus Screwmented Ones Based on Virtual Implant Position: A Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04372901
• Other study ID #: 123987
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2021
• Est. completion date: April 2022

Study information

• Verified date: April 2021
• Source: Cairo University
• Contact: Iman Radi, PhD
• Phone: 01001539613
• Email: iman.abdelwahab[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

CAD/CAM (computer aided design/ computer aided manufacturing) constructed screw retained implant supported frameworks give solutions for the problems arising from the lost wax technique by improving accuracy, adaptation and passive fit of the final restoration. However, concerns about the passive fit of a pre-implant insertion CAD/CAM constructed framework still exists due to the expected errors in imaging, registration, surgical guide construction, adaptation and hence transferring the planned position intra-orally.

Description:

9. PICO Format: Population: mandibular free end saddle requiring 2 implants. Intervention:

Digitally fabricated screw-mented retained metal frameworks constructed before implant placement Control: Digitally fabricated screw retained metal frameworks constructed after implant placement

Outcome:

Outcome Measuring device Measuring unit Passive fit One screw test Binary 13 Screw resistance Binary Radiographic ( digital periapical radiography) Binary III. Methods A) Participants, interventions & outcomes 9. Study settings: i. The study will be conducted at Department of Oral Implantology, faculty of oral and dental medicine, Cairo University, Egypt. ii. Participants will be selected from the outpatient clinic of implantology department, faculty of oral and dental medicine, Cairo University, Egypt. 10. Eligibility criteria: A-Inclusion criteria: i- Mandibular Kenndy Class I. ii- Opposing completely dentulous, fully or partially restored dentition. iii- Good oral hygiene. iv- The patient should have bone for implants, minimum bone height 10 mm and minimum bone diameter should be 6 mm. v- Adequate inter arch space for restoration 15mm or more. vi- Adult patients age ≥18 years B- Exclusion criteria: i. any medical disorder that could complicate surgical phase or affect osteointegration. Radiation chemotherapy. ii. smokers more than 10/daily. iii. Uncooperative patients. iv. Patients with Para-functional habits v. Patients with severe periodontal diseases. vi. Patients with limited mouth opening. vii. Presence of intraoral pathological lesions. viii. Diabetic (HbA1c >7.5%).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 8
• Est. completion date: April 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

.Inclusion Criteria:

• Mandibular Kenndy Class I.

• 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 15 mm or more.

• Adult patients age =18 years

Exclusion Criteria:

• - . any medical disorder that could complicate surgical phase or affect osteointegration. Radiation chemotherapy.

• ii. smokers more than 10/daily.

• iii. Uncooperative patients.

• iv. Patients with Para-functional habits

• v. Patients with severe periodontal diseases.

• vi. Patients with limited mouth opening.

• vii. Presence of intraoral pathological lesions.

• viii. Diabetic (HbA1c >7.5%)

Related Conditions & MeSH terms

• Edentulous
• Jaw
• Mouth, Edentulous

Intervention

Procedure:
• Digitally constructed frameworks before implant placement
Intervention group in which the edentulous area will be restored with 3-implant screwmented CAD/CAM frameworks constructed based on planned implant positions.
• Digitally constructed frameworks after implant placement
Control group: edentulous area will be restored with 3-implant conventional screw retained CAD/CAM frameworks constructed after implant placement.

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, 

References & Publications (1)

de França DG, Morais MH, das Neves FD, Barbosa GA. Influence of CAD/CAM on the fit accuracy of implant-supported zirconia and cobalt-chromium fixed dental prostheses. J Prosthet Dent. 2015 Jan;113(1):22-8. doi: 10.1016/j.prosdent.2014.07.010. Epub 2014 Sep 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Passive fit	Evaluation of Passive fit between CAD/CAM Implant Supported Screw-retained Metal Frameworks Based on Actual Versus Screwmented Ones Based on Virtual Implant Position using one screw test .	10 weeks