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Digital Impression in Neonates

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05929560
Enrollment
7
Registered
2023-07-03
Start date
2023-02-01
Completion date
2023-06-15
Last updated
2023-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Unilateral Complete Cleft Lip and Palate

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 \[conventional impression technique to digital impression\]

Interventions

Palatal impressions obtained using an irreversible hydrocolloid impression material

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)

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Paired design Same patients receive conventional impression and digital

Eligibility

Sex/Gender
ALL
Age
1 Days to 28 Days
Healthy volunteers
No

Inclusion criteria

* patients with unilateral complete cleft lip and palate * neonates

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Deviation of linear measurmentsup to 1 monthThe 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

MeasureTime frameDescription
Assessment of gaurdian' perception and experienceup to 1 monthThe 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026