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Digital Versus Conventional Impression Technique in Mandibular Arch

Primary Purpose

Edentulous Jaw

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
intraoral scanner of nonsplinted scan bodies
impression material
intraoral scanner of splinted scan bodies
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Edentulous Jaw

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Faculty of Dentistry Ain Shams UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Conventional impression

digital impression without splinting the scan bodies

digital impression with splinting the scan bodies

Arm Description

Impression will be taken conventionally using rubber base open tray

Impression will be taken by intraoral scaner

Impression will be taken by intraoral scaner

Outcomes

Primary Outcome Measures

linear accuracy of impressions by superimposition
accurate details recorded by superimposition of the impressions using geomagic software program by measuring linear deviation in millimeters
Angular accuracy of impressions by superimposition
accurate details recorded by superimposition of the impressions using geomagic software program by measuring angular displacements in degrees
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

Secondary Outcome Measures

Full Information

First Posted
February 16, 2023
Last Updated
October 21, 2023
Sponsor
Ain Shams University
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1. Study Identification

Unique Protocol Identification Number
NCT05770011
Brief Title
Digital Versus Conventional Impression Technique in Mandibular Arch
Official Title
Accuracy of Impression Techniques and Their Effect on the Passive Fit of Screw- Retained Bar Splinting Two Interforaminal Implants
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous Jaw

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
one control group and two comparator groups
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
triple blinded
Allocation
Randomized
Enrollment
27 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional impression
Arm Type
Active Comparator
Arm Description
Impression will be taken conventionally using rubber base open tray
Arm Title
digital impression without splinting the scan bodies
Arm Type
Experimental
Arm Description
Impression will be taken by intraoral scaner
Arm Title
digital impression with splinting the scan bodies
Arm Type
Experimental
Arm Description
Impression will be taken by intraoral scaner
Intervention Type
Device
Intervention Name(s)
intraoral scanner of nonsplinted scan bodies
Intervention Description
scanning of non splinted scan bodies
Intervention Type
Device
Intervention Name(s)
impression material
Intervention Description
conventional recording
Intervention Type
Device
Intervention Name(s)
intraoral scanner of splinted scan bodies
Intervention Description
scanning of splinted scan bodies
Primary Outcome Measure Information:
Title
linear accuracy of impressions by superimposition
Description
accurate details recorded by superimposition of the impressions using geomagic software program by measuring linear deviation in millimeters
Time Frame
1 year
Title
Angular accuracy of impressions by superimposition
Description
accurate details recorded by superimposition of the impressions using geomagic software program by measuring angular displacements in degrees
Time Frame
1 year
Title
passive fit of screw retained bars
Description
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
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bassant Sherif, BDS MSc
Phone
01001106591
Email
Bassantsherif62@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed Mostafa, BDS MSc PhD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marwa El Kassaby, PhD
Organizational Affiliation
Ain Shams University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of Dentistry Ain Shams University
City
Cairo
ZIP/Postal Code
11361
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marwa El Kassaby

12. IPD Sharing Statement

Plan to Share IPD
No

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Digital Versus Conventional Impression Technique in Mandibular Arch

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