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

Study Overview
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Brief Summary
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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
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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%).

Official Title
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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

Conditions
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Edentulous, Jaw

Intervention / Treatment
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* Procedure: Digitally constructed frameworks before implant placement
* Procedure: Digitally constructed frameworks after implant placement


Participation Criteria
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Eligibility Criteria
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.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%)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Trial design to be conducted is RCT, split mouth , two arms, and Equivalence frame with 1:1 allocation ratio.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: digitally constructed frameworks before implant placement<br>Intervention group in which the edentulous area will be restored with 3-implant screwmented CAD/CAM frameworks constructed based on planned implant positions. | Procedure: Digitally constructed frameworks before implant placement<br>* Intervention group in which the edentulous area will be restored with 3-implant screwmented CAD/CAM frameworks constructed based on planned implant positions.<br>|
| Active Comparator: digitally constructed frameworks after implant placement<br>Control group: edentulous area will be restored with 3-implant conventional screw retained CAD/CAM frameworks constructed after implant placement | Procedure: Digitally constructed frameworks after implant placement<br>* Control group: edentulous area will be restored with 3-implant conventional screw retained CAD/CAM frameworks constructed after implant placement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Passive, Fit, Screwmented, CAD/CAM, Frameworks