NCT05535530

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

August 4, 2022

Completed
11 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2022

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 10, 2022

Completed
Last Updated

September 21, 2022

Status Verified

September 1, 2022

Enrollment Period

1.6 years

First QC Date

August 4, 2022

Last Update Submit

September 17, 2022

Conditions

Cleft Lip and Palate

Keywords

Cleft lip and palateBilateralPresurgical orthopaedic appliance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Parents Perception and experience

    T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)

  • Linear measurement (experimental group and control group)

    T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)

  • Angular measurement (experimental group and control group)

    T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)

  • Vertical measurement (experimental group and control group)

    T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)

Study Arms (2)

Control group

NO INTERVENTION

Passive PSIO will be used

Experimental

EXPERIMENTAL

Active PSIO will be used

Device: Active PSIO

Interventions

Active PSIODEVICE

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.

Experimental

Eligibility Criteria

Age5 Days - 2 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • \. Healthy new born infants with complete bilateral cleft lip, alveolus and palate.
  • \. Non-syndromic. 3. Non-operated cases.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mushreq Abed

Baghdad, Al-Rusafa, 01110, Iraq

Location

MeSH Terms

Conditions

Cleft Lip

Condition Hierarchy (Ancestors)

Lip DiseasesMouth DiseasesStomatognathic DiseasesMouth AbnormalitiesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 4, 2022

First Posted

September 10, 2022

Study Start

January 1, 2021

Primary Completion

August 15, 2022

Study Completion

September 1, 2022

Last Updated

September 21, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations

IR(1)