Edentulous, Jaw
Conditions
Keywords
Passive, Fit, Screwmented, CAD/CAM, Frameworks
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.
Detailed 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%).
Interventions
PROCEDUREDigitally 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.
PROCEDUREDigitally 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.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
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 .
Intervention model description
Trial design to be conducted is RCT, split mouth , two arms, and Equivalence frame with 1:1 allocation ratio.
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
.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%)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Passive fit | 10 weeks | 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 . |
Countries
Egypt
Contacts
Primary ContactIman Radi, PhD
Backup Contactmohamed Elsayyed, BDS
Outcome results
None listed