Digital Impression in Neonates

NCT05929560 | Completed

• 1 other identifier: Digital_impression_neonates_23
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief Summary

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 \[conventional impression technique to digital impression\]

Conditions

Unilateral Complete Cleft Lip and Palate

Outcome Measures

Primary Outcomes (1)

• Deviation of linear measurments

  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.),

  up to 1 month

Secondary Outcomes (1)

• Assessment of gaurdian' perception and experience

  up to 1 month

Study Arms (2)

Conventional impression

ACTIVE COMPARATOR

Other: Conventional impression

Digital impression

EXPERIMENTAL

Other: Digital impression

Interventions

Conventional impression OTHER

Palatal impressions obtained using an irreversible hydrocolloid impression material

Conventional impression

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)

Digital impression

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• patients with unilateral complete cleft lip and palate
• neonates

You may not qualify if:

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

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria Faculty of Dentistry

Alexandria, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer of DPH and Clinical statistician

Model Details: Paired design "Same patients receive conventional impression and digital"

Study Record Dates

• First Submitted: June 25, 2023
• First Posted: July 3, 2023
• Study Start: February 1, 2023
• Primary Completion: June 15, 2023
• Study Completion: June 15, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

EG (1)