Clinical trial NCT04372901: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Edentulous
Jaw
Keywords: Passive
Fit
Screwmented
CAD/CAM
Frameworks
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2020-05-04
Enrollment: 8
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Trial design to be conducted is RCT, split mouth , two arms, and Equivalence frame with 1:1 allocation ratio.
Primary purpose: TREATMENT

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%).

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%)

Primary outcomes:
measure: Passive fit
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dentistry
state: Manial
Study officials:
affiliation: Teaching assistant MIU
name: Mohamed El-Sayyed, BDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Lecturer of prosthodontics, Faculty of Dentistry, Cairo Univerusty
name: Mohamed ElKhashab, Phd
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Iman Radi, Phd
role: STUDY_DIRECTOR
References:
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.