The Effect of a Newly Designed Presurgical Orthopedic Appliance

Cleft Lip and Palate Clinical Trial

Official title:

The Effect of a Newly Designed Presurgical Orthopedic Appliance on Maxillary Arch Dimensions in Infants With Bilateral Cleft Lip and Palate: Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05535530
• Other study ID #: 262421
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: September 2022
• Source: University of Baghdad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 1, 2022
• Est. primary completion date: August 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Days to 2 Months

Eligibility

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.

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Lip and Palate

Intervention

Device:
• Active PSIO
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.

Locations

Country	Name	City	State
Iraq	Mushreq Abed	Baghdad	Al-Rusafa

Sponsors (1)

Lead Sponsor	Collaborator
University of Baghdad

Country where clinical trial is conducted

Iraq, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arch dimension (experimental group and control group)	Evaluation of the efficiency of a newly designed presurgical infant orthopedic for bilateral cleft lip and palate patients by measuring the maxillary arch dimension at the beginning and end of treatment in both experimental and control group.	T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)
Secondary	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 16 validated preformed questions. The onset of the sign of the positive correction of the cleft segments will be recorded accordingly. In addition, PSIO management, including the removable appliance's hygiene maintenance, was also assessed.	T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)
Secondary	Linear measurement (experimental group and control group)	The linear measurements of arch dimensions in millimeter before and after treatment with the new presurgical infant orthopedic within the cleft patients in both experimental and control group.; Linear measurements for maxillary arch assessments in millimeters: Antero-posterior arch length (I-RTLT); Posterior arch width (RT-LT); Alveolar cleft widths (AP); Right: RP-RA and left: LP-LA; Mid-palatal arch width (RM-LM)	T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)
Secondary	Angular measurement (experimental group and control group)	The angular measurements of arch dimensions before and after treatment with the new presurgical infant orthopedic within the cleft patients in both experimental and control group.; Angular measurements for maxillary arch assessments in degrees: Vertical deviation amount of premaxilla; Horizontal deviation amount of premaxilla	T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)
Secondary	Vertical measurement (experimental group and control group)	The vertical measurements of arch dimensions in millimeter before and after treatment with the new presurgical infant orthopedic within the cleft patients in both experimental and control group.; Vertical measurements for maxillary arch assessments in millimeters: The height of alveolar bone at RM; The height of alveolar bone at LM	T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)