Cleft Lip and PalateNCT05535530
The Effect of a Newly Designed Presurgical Orthopedic Appliance
A study testing Active PSIO in people with Cleft Lip and Palate, run by University of Baghdad at 1 site in Iraq.
Trial summary
A randomized clinical trial to compare the effectiveness of newly designed active type of presurgical orthopedic appliances on maxillary arch dimensions in infants with bilateral cleft lip and palate. Read more about this study
- Who is it for?
- Ages 5 days to 2 monthsHealthy volunteers can take part
- Conditions the study is for
- Cleft Lip and Palate
- What is being tested?
- Active PSIO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIraq
- Study dates
- 1 Jan 2021to 1 Sep 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 5 days to 2 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 1. Healthy new born infants with complete bilateral cleft lip, alveolus and palate.
- 2. Non-syndromic. 3. Non-operated cases.
Who cannot join
- 1. Infants with systemic syndromes. 2.Facial deformities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of a Newly Designed Presurgical Orthopedic Appliance on Maxillary Arch Dimensions in Infants With Bilateral Cleft Lip and Palate: Randomized Clinical Trial
A randomized clinical trial to compare the effectiveness of newly designed active type of presurgical orthopedic appliances on maxillary arch dimensions in infants with bilateral cleft lip and palate.
Read the detailed description
It is a multicenter randomized clinical trial with two parallel arms. The patients will be randomly divided into two groups, group one: a passive orthopedic appliance will be used, and group two a new designed active orthopedic appliance will be used. Impressions will be taken before starting the treatment (T1) and at the end of treatment (T2) three months later. The effectiveness of the two appliances will be assessed and measured on digital models of the maxillary arch before and after the treatment.
- Conditions
- Cleft Lip and Palate
- Being tested
- Active PSIO
- Keywords
- Cleft lip and palate, Bilateral, Presurgical orthopaedic appliance
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active PSIODevice
new designed active orthopedic appliance will be used. Impressions will be taken before starting the treatment (T1) and at the end of treatment (T2) three months later. The effectiveness of the two appliances will be assessed and measured on digital models of the maxillary arch before and after the treatment.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Passive PSIO will be used |
| Experimental | Experimental | Active PSIO will be used Receives: Device: Active PSIO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arch dimension (experimental group and control group)
Evaluation of the efficiency of a newly designed presurgical infant orthopedic for bilateral cleft lip and palate patients by measuring the maxillary arch dimension at the beginning and end of treatment in both experimental and control group.
Measured: T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)
Secondary outcomes (4)
Parents Perception and experience
The perception and experience of parents of children with cleft lip and palate concerning the use presurgical infant orthopedics using a questionnaire-based cross sectional survey. The assessment of mothers' perception and experience regarding PSIO will be executed using 16 validated preformed questions. The onset of the sign of the positive correction of the cleft segments will be recorded accordingly. In addition, PSIO management, including the removable appliance's hygiene maintenance, was also assessed.
Measured: T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)
Linear measurement (experimental group and control group)
The linear measurements of arch dimensions in millimeter before and after treatment with the new presurgical infant orthopedic within the cleft patients in both experimental and control group.
Linear measurements for maxillary arch assessments in millimeters:
- Antero-posterior arch length (I-RTLT)
- Posterior arch width (RT-LT)
- Alveolar cleft widths (AP); Right: RP-RA and left: LP-LA
- Mid-palatal arch width (RM-LM)
Measured: T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)
Angular measurement (experimental group and control group)
The angular measurements of arch dimensions before and after treatment with the new presurgical infant orthopedic within the cleft patients in both experimental and control group.
Angular measurements for maxillary arch assessments in degrees:
- Vertical deviation amount of premaxilla
- Horizontal deviation amount of premaxilla
Measured: T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)
Vertical measurement (experimental group and control group)
The vertical measurements of arch dimensions in millimeter before and after treatment with the new presurgical infant orthopedic within the cleft patients in both experimental and control group.
Vertical measurements for maxillary arch assessments in millimeters:
- The height of alveolar bone at RM
- The height of alveolar bone at LM
Measured: T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start1 Jan 2021
- Primary completion15 Aug 2022
- Study completion1 Sep 2022
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 University of BaghdadThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mushriq F. Abid, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05535530
- Sponsor's protocol ID
- 262421
- Status last verified
- Sep 2022
- First submitted
- 4 Aug 2022
- Last updated
- 21 Sep 2022
- Results posted
- 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 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Newly Designed Presurgical Orthopedic Appliance on Maxillary Arch Dimensions in Infants With Bilateral Cleft Lip and Palate: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05535530
- Acronym / sponsor ID
- 262421
- Conditions
- Cleft Lip and Palate
- Keywords
- Cleft lip and palate, Bilateral, Presurgical orthopaedic appliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 10 Sep 2022 (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.
A randomized clinical trial to compare the effectiveness of newly designed active type of presurgical orthopedic appliances on maxillary arch dimensions in infants with bilateral cleft lip and palate.
Detailed description
It is a multicenter randomized clinical trial with two parallel arms. The patients will be randomly divided into two groups, group one: a passive orthopedic appliance will be used, and group two a new designed active orthopedic appliance will be used. Impressions will be taken before starting the treatment (T1) and at the end of treatment (T2) three months later. The effectiveness of the two appliances will be assessed and measured on digital models of the maxillary arch before and after the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Passive PSIO will be used |
| Experimental | Experimental | Device: Active PSIOActive PSIO will be used |
Who may qualify
- Ages
- 5 days to 2 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 1. Healthy new born infants with complete bilateral cleft lip, alveolus and palate.
- 2. Non-syndromic. 3. Non-operated cases.
Key exclusion criteria (1 listed)
- 1. Infants with systemic syndromes. 2.Facial deformities.
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 |
|---|---|---|
| Active PSIOnew designed active orthopedic appliance will be used. Impressions will be taken before starting the treatment (T1) and at the end of treatment (T2) three months later. The effectiveness of the two appliances will be assessed and measured on digital models of the maxillary arch before and after the treatment. | Device | Experimental |
Primary outcome
Arch dimension (experimental group and control group)
Time frame: T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)
Evaluation of the efficiency of a newly designed presurgical infant orthopedic for bilateral cleft lip and palate patients by measuring the maxillary arch dimension at the beginning and end of treatment in both experimental and control group.
4 secondary outcomes
Parents Perception and experience
Time frame: T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)
Linear measurement (experimental group and control group)
Time frame: T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)
Angular measurement (experimental group and control group)
Time frame: T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)
Vertical measurement (experimental group and control group)
Time frame: T1 before starting any treatment and T2 After treatment before surgical repair (average 3 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 21 Sep 2022.
- 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.
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 Active PSIO in people with Cleft Lip and Palate, run by University of Baghdad at 1 site in Iraq.
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 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 21 Sep 2022. 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 Iraq. 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?
Arch dimension (experimental group and control group) (time frame: T1 before starting any treatment and T2 After treatment before surgical repair (average 3 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 21 Sep 2022.