Digital Versus Conventional Impression Technique in Mandibular Arch

NCT ID: NCT05770011

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2024-05-01

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.

Conditions

Edentulous Jaw

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Conventional impression

Impression will be taken conventionally using rubber base open tray

Group Type: ACTIVE_COMPARATOR

impression material

Intervention Type: DEVICE

conventional recording

digital impression without splinting the scan bodies

Impression will be taken by intraoral scaner

Group Type: EXPERIMENTAL

intraoral scanner of nonsplinted scan bodies

Intervention Type: DEVICE

scanning of non splinted scan bodies

digital impression with splinting the scan bodies

Impression will be taken by intraoral scaner

Group Type: EXPERIMENTAL

intraoral scanner of splinted scan bodies

Intervention Type: DEVICE

scanning of splinted scan bodies

Interventions

intraoral scanner of nonsplinted scan bodies

scanning of non splinted scan bodies

Intervention Type: DEVICE

impression material

conventional recording

Intervention Type: DEVICE

intraoral scanner of splinted scan bodies

scanning of splinted scan bodies

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Bassant Sherif Gamal eldin

assistant lecturer of OMF prosthodontics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marwa El Kassaby, PhD

Role: STUDY_DIRECTOR

Ain Shams University

Locations

Faculty of Dentistry Ain Shams University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

2351992

Identifier Type: -

Identifier Source: org_study_id