Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06592066

Digital Intraoral Scanning With and Without Prefabricated Landmarks Versus Conventional Impression Technique

The aim of this clinical trial is to evaluate the accuracy of digital implant impressions with or without prefabricated landmarks between scan bodies compared to conventional impression technique in mandibular full-arch implant cases.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Implant-supported full arch dental prostheses are crucial and reliable alternatives for individuals with missing teeth in their jaws. The initial phase in the production of implant-supported prostheses involves the impression-taking process. Inaccurate impressions can result in a misfit between the prosthesis and implant abutment, potentially causing both mechanical and biological complications that can adversely affect the long-term viability of the implants. Therefore, the precision of impressions is of utmost importance, particularly for prostheses supported by multiple implants.

The conventional approach to obtaining impressions for multiple implants involves the use of an open-tray technique, widely adopted in dental practice. In this method, impression copings are connected to prevent rotational movements, making it a preferable choice compared to the non-splinting technique. Nevertheless, this procedure is complex, less efficient, and demands considerable clinical expertise. It is advised for use by experienced dentists, as those lacking experience have shown a notably higher rate of unsuccessful outcomes when employing the splinting technique.6 Additionally, various factors, such as patients' pharyngeal reflex and the potential deformation of impression materials, can influence the accuracy of implant impressions in the conventional workflow.

With the advancement of computer-aided design/computer-aided manufacturing (CAD/CAM) and digital technologies, the intraoral scanner (IOS) has gained popularity for capturing implant positions. In clinical practice, IOSs are valued for their comfort, efficiency, and practicality. However, it's important to note that IOSs cannot completely replace traditional methods. When it comes to implant-supported fixed dental prostheses, intraoral scanners can effectively be used for single- and three-unit implant scanning.

In a study from 2020, Revell et al. recommended specific scanners, such as Primescan, for complete-arch implant impressions due to their low deviation values at the implant platform level. Nevertheless, the accuracy of older models of intraoral scanners may not be reliable when scanning edentulous spaces with long inter-implant distances or fully edentulous jaws, particularly in the hands of inexperienced operators.

Previous research has introduced custom-designed scan bodies featuring an extensional structure to achieve dependable digital full-arch implant impressions. Typically, these platforms necessitate the use of custom-made scan bodies or a secondary scan to obtain mucosal information. In this context, this study is conducted to present newly designed prefabricated landmarks between the scan bodies to offer a solution for digital scanning of a mandibular full-arch implant. Therefore, the aim of this study is to evaluate and compare the accuracy of digital intraoral scanning with or without prefabricated landmarks to conventional impression techniques in mandibular full-arch implant cases.

The null hypothesis posits that there would be no significant difference in accuracy between digital intraoral scanning with or without prefabricated landmarks between scan bodies and conventional impression techniques.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • patients with completely edentulous mandible, non-smokers, 50-70 years in age, have Good oral hygiene and motivation.

Exclusion criteria

  • patients with major systemic diseases that may affect osseointegration as uncontrolled diabetes mellitus, the need for extensive bone grafting in planned implant site, pregnancy, patients under bisphosphonate treatment, and limited mouth-opening for executing the guided implant surgery.

Treatment and study plan

Digital Impression by using Intraoral Scanning of Scan Bodies

Device

intraoral scanning will be used to capture the positions of full-arch mandibular implants with the aid of scan bodies.

Digital Impression by using Intraoral Scanning of Scan Bodies with Prefabricated Landmarks

Device

intraoral scanning will be used to capture the positions of full-arch mandibular implants with the aid of scan bodies with prefabricated landmarks in place.

Splinted Open Top Tay Conventional Impression Technique

Device

Splinted open-top tray conventional impression technique will be preformed by using medium body silicone impression material.

Primary outcomes

  1. The accuracy of digital intraoral scanning of full-arch mandibular implants.

    Time frame: Baseline

    Improving digital intraoral scanning of mandibular full-arch implant cases will facilitate the impression procedure, omit the drawback of conventional impression, improve the passive fit, and address the biomechanical considerations of the final-full arch prosthesis.

Study contacts

Contact information is provided by the study sponsor or research team.

Kirollos S. Shanoudy, PHD candidate

CONTACT

[email protected]

01280180780

Omnia M. Refai, PHD

CONTACT

[email protected]

01202420046 ext. +02

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study title

Accuracy of Digital Intraoral Scanning With and Without Prefabricated Landmarks Versus Conventional Impression Technique for Mandibular Implant Supported Full-Arch Prosthesis

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.