The Effect of a Newly Designed Presurgical Orthopedic Appliance

University of Baghdad

Status: Completed

Conditions: Cleft Lip and Palate

Treatments: Device: Active PSIO

Study type: Interventional

Funder types: Other

Identifiers

NCT05535530

262421

Details and patient eligibility

About

A randomized clinical trial to compare the effectiveness of newly designed active type of 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, and group two a new designed active orthopedic appliance will be used. 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.

Enrollment: 30 patients

Sex: All

Ages: 5 days to 2 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 1. Healthy new born infants with complete bilateral cleft lip, alveolus and palate.

  2. Non-syndromic. 3. Non-operated cases.

Exclusion criteria

• 1. Infants with systemic syndromes. 2.Facial deformities.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Control group

No Intervention group

Description:

Passive PSIO will be used

Experimental

Experimental group

Description:

Active PSIO will be used

Treatment:

Device: Active PSIO