Unilateral Complete Cleft Lip and PalateNCT05929560
Digital Impression in Neonates
A study testing Conventional impression and Digital impression in people with Unilateral Complete Cleft Lip and Palate, run by Alexandria University at 1 site in Egypt.
Trial 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] Read more about this study
- Who is it for?
- Ages 1 day to 28 days
- Conditions the study is for
- Unilateral Complete Cleft Lip and Palate
- What is being tested?
- Conventional impression and Digital impression
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2023to 15 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- patients with unilateral complete cleft lip and palate
- neonates
Who cannot join
- infants and children
- bilateral cleft lip and palatal
- incomplete cleft lip
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diagnostic Evaluation and Guardian Assessment of Using Digital Impression in Neonates Versus the Conventional Techniques.
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
- Being tested
- Conventional impression, Digital impression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional impressionOther
Palatal impressions obtained using an irreversible hydrocolloid impression material
Digital impressionOther
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)
| Study group | Role | What they receive |
|---|---|---|
| Conventional impression | Active comparator | Not described Receives: Other: Conventional impression |
| Digital impression | Experimental | Not described Receives: Other: Digital impression |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.),
Measured: up to 1 month
Secondary outcomes (1)
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
Measured: up to 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Feb 2023
- Primary completion15 Jun 2023
- Study completion15 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unilateral Complete Cleft Lip and PalateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Paired design "Same patients receive conventional impression and digital"
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05929560
- Sponsor's protocol ID
- Digital_impression_neonates_23
- Status last verified
- Jun 2023
- First submitted
- 25 Jun 2023
- Last updated
- 3 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diagnostic Evaluation and Guardian Assessment of Using Digital Impression in Neonates Versus the Conventional Techniques.
- ClinicalTrials.gov ID
- NCT05929560
- Acronym / sponsor ID
- Digital_impression_neonates_23
- Conditions
- Unilateral Complete Cleft Lip and Palate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- 15 Jun 2023 (actual)
- Study completion
- 15 Jun 2023 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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]
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Paired design "Same patients receive conventional impression and digital"
| Arm | Type | Receives |
|---|---|---|
| Conventional impression | Active comparator | Other: Conventional impression |
| Digital impression | Experimental | Other: Digital impression |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- patients with unilateral complete cleft lip and palate
- neonates
Key exclusion criteria (3 listed)
- infants and children
- bilateral cleft lip and palatal
- incomplete cleft lip
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional impressionPalatal impressions obtained using an irreversible hydrocolloid impression material | Other | Conventional impression |
| Digital impressionafter 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) | Other | Digital impression |
Primary outcome
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.),
1 secondary outcome
Assessment of gaurdian' perception and experience
Time frame: up to 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional impression and Digital impression in people with Unilateral Complete Cleft Lip and Palate, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Deviation of linear measurments (time frame: up to 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.