An interventional study of Lip taping in Cleft Lip and Palate, sponsored by University of Baghdad. Recruiting at 1 site in Iraq. Open to participants aged 1 Day to 1 Month, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-08.
Sponsored by University of Baghdad · Not applicable, Interventional, and Treatment
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.
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.
168 studies on the registry are indexed under Cleft Lip; 51 are open to participants now.
This study's planned enrollment of 24 is below the median of 30 across 116 interventional studies indexed under Cleft Lip.
Browse Cleft Lip studies →University of Baghdad is the lead sponsor of 170 studies on the registry; 69 are open to participants now.
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Exclusion Criteria:
Will receive passive baby feeding plate and conventional steri strip
Device: Lip taping
will receive passive baby feeding plate and custom-made tape (Steri Srip and orthodontic elastics)
Device: Lip taping
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.
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.
Time frame: T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)]
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')
Time frame: 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')
Time frame: 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.
Time frame: T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)]
Plan to share: No
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