Back to resultsDigital Impression in Neonates
Primary Purpose
Unilateral Complete Cleft Lip and Palate
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Conventional impression
Digital impression
Sponsored by
About this trial
This is an interventional treatment trial for Unilateral Complete Cleft Lip and Palate
Eligibility Criteria
Inclusion Criteria: patients with unilateral complete cleft lip and palate neonates Exclusion Criteria: infants and children bilateral cleft lip and palatal incomplete cleft lip
Sites / Locations
- Alexandria Faculty of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional impression
Digital impression
Arm Description
Outcomes
Primary Outcome Measures
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.),
Secondary Outcome Measures
Assessment of gaurdian' perception and experience
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05929560
Brief Title
Digital Impression in Neonates
Official Title
Diagnostic Evaluation and Guardian Assessment of Using Digital Impression in Neonates Versus the Conventional Techniques.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
June 15, 2023 (Actual)
Study Completion Date
June 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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]
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Unilateral Complete Cleft Lip and Palate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Paired design "Same patients receive conventional impression and digital"
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional impression
Arm Type
Active Comparator
Arm Title
Digital impression
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Conventional impression
Intervention Description
Palatal impressions obtained using an irreversible hydrocolloid impression material
Intervention Type
Other
Intervention Name(s)
Digital impression
Intervention Description
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 Outcome Measure Information:
Title
Deviation of linear measurments
Description
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.),
Time Frame
up to 1 month
Secondary Outcome Measure Information:
Title
Assessment of gaurdian' perception and experience
Description
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
Time Frame
up to 1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
patients with unilateral complete cleft lip and palate
neonates
Exclusion Criteria:
infants and children
bilateral cleft lip and palatal
incomplete cleft lip
Facility Information:
Facility Name
Alexandria Faculty of Dentistry
City
Alexandria
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Digital Impression in Neonates
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