Cleft Lip and PalateNCT02881606
Evaluation of the Clinical Effectiveness of Naso-alveolar Molding (NAM) Versus Computer Aided Design NAM (CAD/NAM) in Infants With Bilateral Cleft Lip and Palate: A Randomized Clinical Trial
A study testing Naso-alveolar molding (NAM) and Computer aided design NAM (CAD/NAM) in people with Cleft Lip and Palate, run by Cairo University at 1 site in Egypt.
Trial summary
Bilateral cleft lip and palate neonates will be randomly assigned to one of two groups: (gp1 presurgical Naso-alveolar molding (NAM) using Grayson method, gp 2 computer aided design NAM (CAD/NAM). Read more about this study
- Who is it for?
- Ages 7 to 60 days
- Conditions the study is for
- Cleft Lip and Palate
- What is being tested?
- Naso-alveolar molding (NAM) and Computer aided design NAM (CAD/NAM)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteEgypt
- Study dates
- Dec 2016to May 2019
- 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 7 to 60 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Bilateral cleft lip and palate
Who cannot join
- Patients without cleft palate Unilateral cleft lip Patients having systemic medical problems that contraindicate NAM treatment Patients with history of previous presurgical infant orthopedics Patients with history of any surgical procedures (ex: lip adhesion)
Trial locations and contacts
1 site in 1 country.
About this study
Bilateral cleft lip and palate neonates will be randomly assigned to one of two groups: (gp1 presurgical Naso-alveolar molding (NAM) using Grayson method, gp 2 computer aided design NAM (CAD/NAM). The aim of the study is to compare between short term clinical effects of both interventions as regards alveolar alignment, nasal esthetics and interlabial gap.
- Conditions
- Cleft Lip and Palate
- Being tested
- Naso-alveolar molding (NAM), Computer aided design NAM (CAD/NAM)
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naso-alveolar molding (NAM)Device
Computer aided design NAM (CAD/NAM)Device
| Study group | Role | What they receive |
|---|---|---|
| Naso-alveolar molding (NAM) | Active comparator | Active plates and nasal stents (Grayson method) Receives: Device: Naso-alveolar molding (NAM) |
| Computer aided design NAM (CAD/NAM) | Active comparator | Computer aided design active plates and nasal stents Receives: Device: Computer aided design NAM (CAD/NAM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alveolar alignment
Reference points,lines and planes on digital models recording the symmetry and alignment of maxillary arch segments
Measured: 5-6 months
Secondary outcomes (1)
Nasal and labial esthetics
Reference points, lines and planes on standardized photos recording the collumellar length, symmetry of nostrils and interlabial gap
Measured: 5-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2016 (estimated)
- Study startDec 2016
- Primary completionMar 2019
- Study completionMay 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Lip and PalateStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Ali El Ashmawi, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02881606
- Sponsor's protocol ID
- CEBD-CU-2016-08-184
- Status last verified
- Dec 2019
- First submitted
- 24 Aug 2016
- Last updated
- 3 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Clinical Effectiveness of Naso-alveolar Molding (NAM) Versus Computer Aided Design NAM (CAD/NAM) in Infants With Bilateral Cleft Lip and Palate: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02881606
- Acronym / sponsor ID
- CEBD-CU-2016-08-184
- Conditions
- Cleft Lip and Palate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Mar 2019 (actual)
- Study completion
- May 2019 (actual)
- First posted
- 29 Aug 2016 (estimated)
- 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.
Bilateral cleft lip and palate neonates will be randomly assigned to one of two groups: (gp1 presurgical Naso-alveolar molding (NAM) using Grayson method, gp 2 computer aided design NAM (CAD/NAM). The aim of the study is to compare between short term clinical effects of both interventions as regards alveolar alignment, nasal esthetics and interlabial gap.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Naso-alveolar molding (NAM) | Active comparator | Device: Naso-alveolar molding (NAM)Active plates and nasal stents (Grayson method) |
| Computer aided design NAM (CAD/NAM) | Active comparator | Device: Computer aided design NAM (CAD/NAM)Computer aided design active plates and nasal stents |
Who may qualify
- Ages
- 7 to 60 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Bilateral cleft lip and palate
Key exclusion criteria (1 listed)
- Patients without cleft palate Unilateral cleft lip Patients having systemic medical problems that contraindicate NAM treatment Patients with history of previous presurgical infant orthopedics Patients with history of any surgical procedures (ex: lip adhesion)
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 |
|---|---|---|
| Naso-alveolar molding (NAM) | Device | Naso-alveolar molding (NAM) |
| Computer aided design NAM (CAD/NAM) | Device | Computer aided design NAM (CAD/NAM) |
Primary outcome
Alveolar alignment
Time frame: 5-6 months
Reference points,lines and planes on digital models recording the symmetry and alignment of maxillary arch segments
1 secondary outcome
Nasal and labial esthetics
Time frame: 5-6 months
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 Dec 2019.
- Individual participant dataSharing planned: Yes
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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 Naso-alveolar molding (NAM) and Computer aided design NAM (CAD/NAM) in people with Cleft Lip and Palate, run by Cairo 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 1 inclusion and 1 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 Dec 2019. 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?
Alveolar alignment (time frame: 5-6 months). 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 Dec 2019.