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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-31

Study Completion Date

2022-04-30

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.

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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%).

Conditions

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Edentulous Jaw

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Trial design to be conducted is RCT, split mouth , two arms, and Equivalence frame with 1:1 allocation ratio.

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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 .

Study Groups

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digitally 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.

Group Type EXPERIMENTAL

Digitally constructed frameworks before implant placement

Intervention Type PROCEDURE

Intervention 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

Control group: edentulous area will be restored with 3-implant conventional screw retained CAD/CAM frameworks constructed after implant placement

Group Type ACTIVE_COMPARATOR

Digitally constructed frameworks after implant placement

Intervention Type PROCEDURE

Control group: edentulous area will be restored with 3-implant conventional screw retained CAD/CAM frameworks constructed after implant placement.

Interventions

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Digitally 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.

Intervention Type PROCEDURE

Digitally 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.

Intervention Type PROCEDURE

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%)

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes