The Effect of a Newly Designed Presurgical Orthopedic Appliance

September 17, 2022 updated by: Mushriq F. Abid, University of Baghdad

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
    • Al-Rusafa
      • Baghdad, Al-Rusafa, Iraq, 01110
        • Mushreq Abed

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 3 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control group
Passive PSIO will be used
Experimental: Experimental
Active PSIO will be used
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arch dimension (experimental group and control group)
Time Frame: T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Parents Perception and experience
Time Frame: T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)
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)
Linear measurement (experimental group and control group)
Time Frame: T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)

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)
Angular measurement (experimental group and control group)
Time Frame: T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)

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)
Vertical measurement (experimental group and control group)
Time Frame: T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)

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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Baghdad

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

August 15, 2022

Study Completion (Actual)

September 1, 2022

Study Registration Dates

First Submitted

August 4, 2022

First Submitted That Met QC Criteria

September 7, 2022

First Posted (Actual)

September 10, 2022

Study Record Updates

Last Update Posted (Actual)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 17, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 262421

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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