Digital Versus Conventional Impression Technique in Mandibular Arch

NCT05770011 | Active Not Recruiting

• 1 other identifier: 2351992
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Edentulous Jaw

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (3)

Conventional impression

ACTIVE COMPARATOR

Impression will be taken conventionally using rubber base open tray

Device: impression material

digital impression without splinting the scan bodies

EXPERIMENTAL

Impression will be taken by intraoral scaner

Device: intraoral scanner of nonsplinted scan bodies

digital impression with splinting the scan bodies

EXPERIMENTAL

Impression will be taken by intraoral scaner

Device: intraoral scanner of splinted scan bodies

Interventions

intraoral scanner of nonsplinted scan bodies DEVICE

scanning of non splinted scan bodies

digital impression without splinting the scan bodies

impression material DEVICE

conventional recording

Conventional impression

intraoral scanner of splinted scan bodies DEVICE

scanning of splinted scan bodies

digital impression with splinting the scan bodies

Eligibility Criteria

• Age: 50 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Faculty of Dentistry Ain Shams University

Cairo, 11361, Egypt

Location

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Study Officials

• Marwa El Kassaby, PhD

  Ain Shams University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: triple blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer of OMF prosthodontics

Model Details: one control group and two comparator groups

Study Record Dates

• First Submitted: February 16, 2023
• First Posted: March 15, 2023
• Study Start: February 1, 2023
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)