Two Methods of Lip Taping as a Presurgical Orthopedic Appliance

University of Baghdad

Status: Enrolling

Conditions: Cleft Lip and Palate

Treatments: Device: Lip taping

Study type: Interventional

Funder types: Other

Identifiers

NCT05796336

765423

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 1 day to 1 month old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

24 participants in 2 patient groups

Passive lip taping

Experimental group

Description:

Will receive passive baby feeding plate and conventional steri strip

Treatment:

Device: Lip taping

Custom-made tape

Experimental group

Description:

will receive passive baby feeding plate and custom-made tape (Steri Srip and orthodontic elastics)

Treatment:

Device: Lip taping