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Clinical Trials/NCT05770011
NCT05770011Active, not recruitingNot Applicable

Accuracy of Impression Techniques and Their Effect on the Passive Fit of Screw- Retained Bar Splinting Two Interforaminal Implants

Ain Shams University2 sites in 1 country54 target enrollmentStarted: February 1, 2023Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
54
Locations
2
Primary Endpoint
Angular accuracy of impressions by superimposition

Study Overview

Brief Summary

Objectives: Passive fit of screw retained frameworks is essential to avoid biological and mechanical failures in addition to transmission of unfavourable stresses to the bone-implant interface. However, Several factors contribute to the passive fit of screw retained prosthesis such as relative parallelism between the implants, implant number, impression material, impression technique and method of prothesis fabrication. The current study aims to evaluate the accuracy of three different impression techniques on the fit of screw retained bar splinting two inter-foraminal implants.

Methods: The study presents evaluation of the passive fit of screw retained bar fabricated with three different impression techniques.

Detailed Description

Surgical guide will be designed for completely edentulous patients. It will be inserted into the patient's mouth, stabilized against the upper denture and secured in place. dental implants will then be placed.

For bar fabrication using the first impression technique, closed-top primary impressions will be made followed by open top secondary impression. Extraoral scanning of the impression will be done followed by digital fabrication of the bar.

For bar fabrication using the second impression technique, scanning of the lower arch will be done using Omnicam intraoral scanner. Scanning will be done by a single calibrated operator who is trained on intraoral scanning techniques.

Scan bodies will be then screwed to the implants and scanning will be done. Both scans will be previewed on the computer desktop and superimposed together. A Standard tessellation language file will be then exported, downloaded and previewed in Inlab Exocad software .Implant system and the bar design will be selected from the software library. Then, the Standard tessellation Language file will be exported to the milling machine and milling of Cobalt chromium bar will be done.

For bar fabrication using the third technique, splinting of scan bodies will be done followed by intraoral scanning of the lower arch.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Masking Description

triple blinded

Eligibility Criteria

Ages
50 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • - Patients' age range from 50 to 65 years old.
  • Good oral hygiene is mandatory.
  • Sufficient restorative space (15mm) to accept implant supported over denture diagnosed by mounting the diagnostic casts.
  • Firm and healthy mucosa covering the alveolar ridge.
  • Minimum bone width 5.5 mm buccolingually and of 12 mm bone height as diagnosed from the pre-operative cone beam computed tomography scan.

Exclusion Criteria

  • Heavy smokers.
  • Patients with para functional habits.
  • Tempromandibular Joint Disorders. (TMJ disorders)
  • Patients with systemic disorders that may affect the results of this study.
  • V-shaped dental arch.

Arms & Interventions

Conventional impression

Active Comparator

Impression will be taken conventionally using rubber base open tray

Intervention: impression material (Device)

digital impression without splinting the scan bodies

Experimental

Impression will be taken by intraoral scaner

Intervention: intraoral scanner of nonsplinted scan bodies (Device)

digital impression with splinting the scan bodies

Experimental

Impression will be taken by intraoral scaner

Intervention: intraoral scanner of splinted scan bodies (Device)

Outcomes

Primary Outcomes

Angular accuracy of impressions by superimposition

Time Frame: 1 year

accurate details recorded by superimposition of the impressions using geomagic software program by measuring angular displacements in degrees

linear accuracy of impressions by superimposition

Time Frame: 1 year

accurate details recorded by superimposition of the impressions using geomagic software program by measuring linear deviation in millimeters

passive fit of screw retained bars

Time Frame: one year

frame work fitting passively using screw resistance test using screw resistance parameter calculated by subtraction of passive and non passive situations angles of rotation in degrees

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Bassant Sherif Gamal eldin

assistant lecturer of OMF prosthodontics

Ain Shams University

Study Sites (2)

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