Comparing two lip taping methods for infants with cleft lip and palate
Effectiveness of Two Methods of Lip Taping as a Presurgical Orthopedic in Infants With Bilateral Cleft Lip and Palate: A Randomized Clinical Trial
This study is testing two different ways to tape the lips of infants with cleft lip and palate to see which method helps their mouth shape better before surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 1 Day to 1 Month |
| Sex | All |
| Sponsor | University of Baghdad Academic / other |
| Locations | 1 site (Baghdad, Al-Rusaffa) |
| Trial ID | NCT05796336 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of two different lip taping methods as presurgical orthopedic appliances for infants with bilateral cleft lip and palate. It is a multicenter randomized trial where participants will be divided into two groups: one using conventional steri strips and the other using a custom-made tape that combines steri strips with orthodontic elastic. Impressions of the maxillary arch will be taken before and after the treatment period of three months to assess the impact of each method on arch dimensions.
Who should consider this trial
Good fit: Ideal candidates for this study are non-syndromic infants aged 1 to 30 days with complete bilateral cleft lip and palate.
Not a fit: Patients with unilateral cleft lip or those with systemic syndromes will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the presurgical management of infants with cleft lip and palate, potentially leading to better surgical outcomes.
How similar studies have performed: While there may be limited studies on lip taping methods, this approach is relatively novel and has not been extensively tested in this specific context.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Baghdad, Al-Rusaffa
- College of Dentistry — Baghdad, Al-Rusaffa, Iraq (Recruiting)
Study contacts
- Study coordinator: Mushriq Abid, PhD
- Email: mushriq.abid@codental.uobaghdad.edu.iq
- Phone: 7718800706
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.