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

Primary Purpose

Edentulous, Jaw

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Digitally constructed frameworks before implant placement
Digitally constructed frameworks after implant placement
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Edentulous focused on measuring Passive, Fit, Screwmented, CAD/CAM, Frameworks

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

.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%)

Sites / Locations

  • Faculty of dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

digitally constructed frameworks before implant placement

digitally constructed frameworks after implant placement

Arm Description

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

Outcomes

Primary Outcome Measures

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 .

Secondary Outcome Measures

Full Information

First Posted
April 24, 2020
Last Updated
April 13, 2021
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04372901
Brief Title
Passive Fit of CAD/CAM Screw-retained Metal Frameworks Versus Screwmented Ones
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 2021 (Anticipated)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
April 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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%).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous, Jaw
Keywords
Passive, Fit, Screwmented, CAD/CAM, Frameworks

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
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 .
Allocation
Randomized
Enrollment
8 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
digitally constructed frameworks before implant placement
Arm Type
Experimental
Arm Description
Intervention group in which the edentulous area will be restored with 3-implant screwmented CAD/CAM frameworks constructed based on planned implant positions.
Arm Title
digitally constructed frameworks after implant placement
Arm Type
Active Comparator
Arm Description
Control group: edentulous area will be restored with 3-implant conventional screw retained CAD/CAM frameworks constructed after implant placement
Intervention Type
Procedure
Intervention Name(s)
Digitally constructed frameworks before implant placement
Intervention Description
Intervention group in which the edentulous area will be restored with 3-implant screwmented CAD/CAM frameworks constructed based on planned implant positions.
Intervention Type
Procedure
Intervention Name(s)
Digitally constructed frameworks after implant placement
Intervention Description
Control group: edentulous area will be restored with 3-implant conventional screw retained CAD/CAM frameworks constructed after implant placement.
Primary Outcome Measure Information:
Title
Passive fit
Description
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 .
Time Frame
10 weeks

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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%)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Iman Radi, PhD
Phone
01001539613
Email
iman.abdelwahab@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
mohamed Elsayyed, BDS
Email
moahmed.elsayed@dentistry.cu.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohamed El-Sayyed, BDS
Organizational Affiliation
Teaching assistant MIU
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mohamed ElKhashab, Phd
Organizational Affiliation
Lecturer of prosthodontics, Faculty of Dentistry, Cairo Univerusty
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Iman Radi, Phd
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of dentistry
City
Cairo
State/Province
Manial
ZIP/Postal Code
12911
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The author of "study will publish it in an internationally acknowledged journal.
Citations:
PubMed Identifier
25277028
Citation
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.
Results Reference
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Passive Fit of CAD/CAM Screw-retained Metal Frameworks Versus Screwmented Ones

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