Cleft Lip and PalateNCT05796336
Two Methods of Lip Taping as a Presurgical Orthopedic Appliance
A study testing Lip taping 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 two methods of lip taping as a 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 1 day to 1 monthHealthy volunteers can take part
- Conditions the study is for
- Cleft Lip and Palate
- What is being tested?
- Lip taping
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIraq
- Study dates
- 12 Jan 2023to 1 May 2024
- 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 1 month
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Non-Syndromic infants with complete bilateral cleft lip and palate.
- Both sexes.
- Age range from 1-30 day
Who cannot join
- Infants with systemic syndromes.
- infants with unilateral cleft
- infants whom parents refuse to consent.
Trial locations and contacts
1 site in 1 country.
Iraq1 site, 1 recruiting
- Recruiting
College of Dentistry
Baghdad, Al-Rusaffa, 01110
Mushriq Abid, PhD, 07718800706 ext. 00964, mushriq.abid@codental.uobaghadad.edu.iq
About this study
Official title: Effectiveness of Two Methods of Lip Taping as a Presurgical Orthopedic in Infants With Bilateral Cleft Lip and Palate: A Randomized Clinical Trial
A randomized clinical trial to compare the effectiveness of two methods of lip taping as a 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 with conventional steri strip, and group two will receive a passive orthopedic appliance with a custom-made tape consist of steri strip and orthodontic elastic. Impressions will be taken before starting the treatment (T1) and at the end of treatment (T2) three months later. The effectiveness of the two methods of taping will be assessed and measured on digital models of the maxillary arch before and after the treatment.
- Conditions
- Cleft Lip and Palate
- Being tested
- Lip taping
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lip tapingDevice
Steri strip tape and passive baby feeding plate Two methods of lip taping will be used with passive baby feeding plate. 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 |
|---|---|---|
| Passive lip taping | Experimental | Will receive passive baby feeding plate and conventional steri strip Receives: Device: Lip taping |
| Custom-made tape | Experimental | will receive passive baby feeding plate and custom-made tape (Steri Srip and orthodontic elastics) Receives: Device: Lip taping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of maxillary arch dimension change
To evaluate the effect of the lip taping as a presurgical orthopedic on the maxillary arch dimensions for infants with bilateral cleft using two different types of medical taping.
Measured: T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)]
Secondary outcomes (3)
Assessment of Linear measurement change
The linear measurements of arch dimensions in millimeter before and after treatment with both methods of lip taping in both experimental groups
Linear measurements for maxillary arch assessments in millimeters:
- Antero-posterior arch length (I-ITT')
- Posterior arch width (T-T')
- Alveolar cleft widths (AP); Right cleft and (A'P') Left cleft
- Mid-palatal arch width (C-C')
Measured: T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)]
Assessment of Angular measurement change
The angular measurements of arch dimensions in degrees before and after treatment with both methods of lip taping in both experimental groups.
Angular measurements for maxillary arch assessments in degrees:
Anterior arch curvature angle (AIA')
Measured: T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)]
Assessment of 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 15 validated preformed questions.
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 posted3 Apr 2023
- Study start12 Jan 2023
- Primary completion1 Mar 2024
- Study completion1 May 2024 (estimated)
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
- 24 participants (estimated)
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
- NCT05796336
- Sponsor's protocol ID
- 765423
- Status last verified
- Apr 2024
- First submitted
- 18 Mar 2023
- Last updated
- 8 Apr 2024
- 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 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Two Methods of Lip Taping as a Presurgical Orthopedic in Infants With Bilateral Cleft Lip and Palate: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05796336
- Acronym / sponsor ID
- 765423
- Conditions
- Cleft Lip and Palate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 May 2024 (estimated)
- First posted
- 3 Apr 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.
A randomized clinical trial to compare the effectiveness of two methods of lip taping as a 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 with conventional steri strip, and group two will receive a passive orthopedic appliance with a custom-made tape consist of steri strip and orthodontic elastic. Impressions will be taken before starting the treatment (T1) and at the end of treatment (T2) three months later. The effectiveness of the two methods of taping 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 |
|---|---|---|
| Passive lip taping | Experimental | Device: Lip tapingWill receive passive baby feeding plate and conventional steri strip |
| Custom-made tape | Experimental | Device: Lip tapingwill receive passive baby feeding plate and custom-made tape (Steri Srip and orthodontic elastics) |
Who may qualify
- Ages
- 1 day to 1 month
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Non-Syndromic infants with complete bilateral cleft lip and palate.
- Both sexes.
- Age range from 1-30 day
Key exclusion criteria (3 listed)
- Infants with systemic syndromes.
- infants with unilateral cleft
- infants whom parents refuse to consent.
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 |
|---|---|---|
| Lip tapingSteri strip tape and passive baby feeding plate Two methods of lip taping will be used with passive baby feeding plate. 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 | Custom-made tape, Passive lip taping |
Primary outcome
Assessment of maxillary arch dimension change
Time frame: T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)]
To evaluate the effect of the lip taping as a presurgical orthopedic on the maxillary arch dimensions for infants with bilateral cleft using two different types of medical taping.
3 secondary outcomes
Assessment of Linear measurement change
Time frame: T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)]
Assessment of Angular measurement change
Time frame: T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)]
Assessment of Parents Perception and experience
Time frame: T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lip taping 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 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: status not confirmed, as of the sponsor's last update on 8 Apr 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mushriq Abid, PhD (7718800706 ext. 00964, mushriq.abid@codental.uobaghdad.edu.iq), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of maxillary arch dimension change (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 8 Apr 2024.