EvaluationNCT06522217
Prosthetic Rehabilitation of Lip and Palate Deformaties in Neonates Using Two Different Approaches
A study testing nasoalveolar molding appliance and digital nasoalveolar molding appliance in people with Evaluation, run by Tanta University at 1 site in Egypt.
Trial summary
This study was conducted to compare the use of conventional nasoalveolar molding appliances and the use of digitally designed and produced nasoalveolar molding appliances in rehabilitating neonates born with unilateral complete cleft lip and palate. Read more about this study
- Who is it for?
- Ages 2 to 4 weeksHealthy volunteers can take part
- Conditions the study is for
- Evaluation
- What is being tested?
- nasoalveolar molding appliance and digital nasoalveolar molding appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Feb 2018to 28 Feb 2022
- 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 2 to 4 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age range from 2-3 weeks after birth.
- Only the Non-syndromic unilateral cleft lip and palate neonates.
- Newborn infants without any surgical intervention.
Who cannot join
- Patients with the life threatening syndromes.
- Respiratory difficulties are not considered for presurgical treatment.
- Uncooperative guardians.
Trial locations and contacts
1 site in 1 country.
About this study
This study was conducted to compare the use of conventional nasoalveolar molding appliances and the use of digitally designed and produced nasoalveolar molding appliances in rehabilitating neonates born with unilateral complete cleft lip and palate.
Read the detailed description
For this prospective study, twenty newborns with non-syndromic complete unilateral cleft lip and palate were referred from the Outpatient Clinics of several pediatric surgeons and obstetricians to the Department of Prosthodontics -Faculty of Dentistry - Tanta University.
Inclusion criteria:
- Age range from 2-3 weeks after birth.
- Only the Non-syndromic unilateral cleft lip and palate neonates.
- Newborn infants without any surgical intervention.
Exclusion criteria:
- Patients with the life threatening syndromes.
- Respiratory difficulties are not considered for presurgical treatment.
- Uncooperative guardians.
- Conditions
- Evaluation
- Being tested
- nasoalveolar molding appliance, digital nasoalveolar molding appliance
- Keywords
- nasoalveolar molding, digital nasoalveolar molding, complete unilateral cleft lip and palate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nasoalveolar molding applianceDevice
making impression then make the conventional lab procedures for group A for the production of conventional appliances
digital nasoalveolar molding applianceDevice
group B scanning the model and designing the appliances on 3shap and 3d printing the appliances
| Study group | Role | What they receive |
|---|---|---|
| Conventional Group A | Active comparator | 10 neonates receiving conventional nasoalveolar molding appliances Receives: Device: nasoalveolar molding appliance |
| Digital Group B | Active comparator | 10 neonates receiving CAD- nasoalveolar molding appliances Receives: Device: digital nasoalveolar molding appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoral measurements
measuring 2 points the first is the intersegmental distance in (mm) and the second is the alveolar width in (mm)
Measured: 3 -4 months
extraoral measurements
- Nostril height in (mm)
- Nasal dome height in (mm)
- Columella height in( mm)
- Nostril basal width in (mm)
- Nostril width in (mm)
Measured: 3-4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2024
- Study start19 Feb 2018
- Primary completion30 Jan 2022
- Study completion28 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EvaluationStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups : Group A receiving conventional nasoalveolar molding appliance and Group B receiving CAD NAM
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Mohamed Abdallah, Tanta University
- Investigators
- hoda amin rashad, phd, Principal investigator, tanta university faculty of dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06522217
- Sponsor's protocol ID
- RP-12-18
- Status last verified
- Jul 2024
- First submitted
- 11 Jul 2024
- Last updated
- 9 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prosthetic Rehabilitation of Lip and Palate Deformaties in Neonates Using Two Different Approaches
- ClinicalTrials.gov ID
- NCT06522217
- Acronym / sponsor ID
- RP-12-18
- Conditions
- Evaluation
- Keywords
- nasoalveolar molding, digital nasoalveolar molding, complete unilateral cleft lip and palate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 19 Feb 2018 (actual)
- Primary completion
- 30 Jan 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 26 Jul 2024 (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.
This study was conducted to compare the use of conventional nasoalveolar molding appliances and the use of digitally designed and produced nasoalveolar molding appliances in rehabilitating neonates born with unilateral complete cleft lip and palate.
Detailed description
For this prospective study, twenty newborns with non-syndromic complete unilateral cleft lip and palate were referred from the Outpatient Clinics of several pediatric surgeons and obstetricians to the Department of Prosthodontics -Faculty of Dentistry - Tanta University.
Inclusion criteria:
- Age range from 2-3 weeks after birth.
- Only the Non-syndromic unilateral cleft lip and palate neonates.
- Newborn infants without any surgical intervention.
Exclusion criteria:
- Patients with the life threatening syndromes.
- Respiratory difficulties are not considered for presurgical treatment.
- Uncooperative guardians.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- 2 groups : Group A receiving conventional nasoalveolar molding appliance and Group B receiving CAD NAM
| Arm | Type | Receives |
|---|---|---|
| Conventional Group A | Active comparator | Device: nasoalveolar molding appliance10 neonates receiving conventional nasoalveolar molding appliances |
| Digital Group B | Active comparator | Device: digital nasoalveolar molding appliance10 neonates receiving CAD- nasoalveolar molding appliances |
Who may qualify
- Ages
- 2 to 4 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age range from 2-3 weeks after birth.
- Only the Non-syndromic unilateral cleft lip and palate neonates.
- Newborn infants without any surgical intervention.
Key exclusion criteria (3 listed)
- Patients with the life threatening syndromes.
- Respiratory difficulties are not considered for presurgical treatment.
- Uncooperative guardians.
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 |
|---|---|---|
| nasoalveolar molding appliancemaking impression then make the conventional lab procedures for group A for the production of conventional appliances | Device | Conventional Group A |
| digital nasoalveolar molding appliancegroup B scanning the model and designing the appliances on 3shap and 3d printing the appliances | Device | Digital Group B |
Primary outcome
intraoral measurements
Time frame: 3 -4 months
measuring 2 points the first is the intersegmental distance in (mm) and the second is the alveolar width in (mm)
extraoral measurements
Time frame: 3-4 months
* Nostril height in (mm) * Nasal dome height in (mm) * Columella height in( mm) * Nostril basal width in (mm) * Nostril width in (mm)
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 9 Oct 2024.
- Individual participant dataSharing planned: No
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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.
hoda amin rashad, phd principal investigator
tanta university faculty of dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nasoalveolar molding appliance and digital nasoalveolar molding appliance in people with Evaluation, run by Tanta 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 3 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 9 Oct 2024. 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?
intraoral measurements (time frame: 3 -4 months). The study lists 2 primary outcomes in all. 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 9 Oct 2024.