Digital Versus Conventional Impression Technique in Mandibular Arch

Edentulous Jaw Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05770011
• Other study ID #: 2351992
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: February 2024
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 54
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Edentulous Jaw
• Jaw, Edentulous

Intervention

Device:
• intraoral scanner of nonsplinted scan bodies
scanning of non splinted scan bodies
• impression material
conventional recording
• intraoral scanner of splinted scan bodies
scanning of splinted scan bodies

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	linear accuracy of impressions by superimposition	accurate details recorded by superimposition of the impressions using geomagic software program by measuring linear deviation in millimeters	1 year
Primary	Angular accuracy of impressions by superimposition	accurate details recorded by superimposition of the impressions using geomagic software program by measuring angular displacements in degrees	1 year
Primary	passive fit of screw retained bars	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	one year