Cleft Lip and Palate
Conditions
Brief 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.
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.
Interventions
DEVICELip 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.
Sponsors
University of Baghdad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
1 Days to 1 Months
Healthy volunteers
Yes
Inclusion criteria
1. Non-Syndromic infants with complete bilateral cleft lip and palate. 2. Both sexes. 3. Age range from 1-30 day
Exclusion criteria
1. Infants with systemic syndromes. 2. infants with unilateral cleft 3. infants whom parents refuse to consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of maxillary arch dimension change | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Linear measurement change | T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)] | 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') |
| Assessment of Angular measurement change | T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)] | 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') |
| Assessment of Parents Perception and experience | T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)] | 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. |
Countries
Iraq
Contacts
Primary ContactMushriq Abid, PhD
Outcome results
None listed