Skip to main content
OpenTrials
Completed

NCT Number: NCT05929560

Digital Impression in Neonates

The goal of this [clinical trial] is to [explore the attitudes of guardians with different educational background regarding the technique of impression registration as well as the compliance to using feeding appliances ] in [neonates].

Researchers will compare [conventional impression technique to digital impression]

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Unilateral Complete Cleft Lip and Palate

Age range

1 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria Faculty of Dentistry

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients with unilateral complete cleft lip and palate
  • neonates

Exclusion criteria

  • infants and children
  • bilateral cleft lip and palatal
  • incomplete cleft lip

Treatment and study plan

Conventional impression

Other

Palatal impressions obtained using an irreversible hydrocolloid impression material

Digital impression

Other

after obtaining stone models from conventional impression material, stone models were scanned using the I700 (Medit) scanner and Patients were directly scanned intraorally using an intraoral 3D scanner Subsequently, the printed 3D model scan data of the seven patients were then used for standard triangulated language (STL)

Primary outcomes

  1. Deviation of linear measurments

    Time frame: up to 1 month

    The stone models obtained from conventional methods and 3D printed models obtained from the intraoral scanning were measured directly three times using an Vernier Fowler Calipers (WESTport Corporation, NY.),

Secondary outcomes

  1. Assessment of gaurdian' perception and experience

    Time frame: up to 1 month

    The assessment of mothers' perception and experience regarding Pre-surgical infant orthopedics (PSIO) was executed using 16 validated preformed question.

    A questionnaire assess parents' satisfaction concerning PSIO

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Diagnostic Evaluation and Guardian Assessment of Using Digital Impression in Neonates Versus the Conventional Techniques.

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jul 3, 2023
Registry last updated
Jul 3, 2023

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.

Related clinical trials

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