Passive Fit of CAD/CAM Screw-retained Metal Frameworks Versus Screwmented Ones
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
1 other identifier
interventional
8
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2020
CompletedFirst Posted
Study publicly available on registry
May 4, 2020
CompletedStudy Start
First participant enrolled
May 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2022
CompletedApril 14, 2021
April 1, 2021
8 months
April 24, 2020
April 13, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
digitally constructed frameworks before implant placement
EXPERIMENTALIntervention 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
ACTIVE COMPARATORControl group: edentulous area will be restored with 3-implant conventional screw retained CAD/CAM frameworks constructed after implant placement
Interventions
Intervention group in which the edentulous area will be restored with 3-implant screwmented CAD/CAM frameworks constructed based on planned implant positions.
Control group: edentulous area will be restored with 3-implant conventional screw retained CAD/CAM frameworks constructed after implant placement.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \- . 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%)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Faculty of dentistry
Cairo, Manial, 12911, Egypt
Related Publications (1)
de Franca 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.
PMID: 25277028BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mohamed El-Sayyed, BDS
Teaching assistant MIU
- STUDY DIRECTOR
Mohamed ElKhashab, Phd
Lecturer of prosthodontics, Faculty of Dentistry, Cairo Univerusty
- STUDY DIRECTOR
Iman Radi, Phd
Cairo University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- The study is based on different technical procedures of fabrication of the frameworks. Since these differences are visible, the operator, the assessor and the technician involved in the study cannot be blinded. Since blinding was not possible, randomization was delayed till the prosthetic phase to avoid any performance bias in the surgical steps. But the statistician will be blinded .
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Master student- Oral implantology -Cairo univeristy
Study Record Dates
First Submitted
April 24, 2020
First Posted
May 4, 2020
Study Start
May 1, 2021
Primary Completion
January 1, 2022
Study Completion
April 1, 2022
Last Updated
April 14, 2021
Record last verified: 2021-04
Data Sharing
- IPD Sharing
- Will not share
The author of "study will publish it in an internationally acknowledged journal.