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The Effect of a Newly Designed Presurgical Orthopedic Appliance

Primary Purpose

Cleft Lip and Palate

Status
Completed
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
Active PSIO
Sponsored by
University of Baghdad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cleft Lip and Palate focused on measuring Cleft lip and palate, Bilateral, Presurgical orthopaedic appliance

Eligibility Criteria

5 Days - 2 Months (Child)All SexesAccepts 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.

Sites / Locations

  • Mushreq Abed

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Experimental

Arm Description

Passive PSIO will be used

Active PSIO will be used

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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)
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
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

Full Information

First Posted
August 4, 2022
Last Updated
September 17, 2022
Sponsor
University of Baghdad
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1. Study Identification

Unique Protocol Identification Number
NCT05535530
Brief Title
The Effect of a Newly Designed Presurgical Orthopedic Appliance
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
August 15, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Baghdad

4. Oversight

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

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Lip and Palate
Keywords
Cleft lip and palate, Bilateral, Presurgical orthopaedic appliance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
Passive PSIO will be used
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Active PSIO will be used
Intervention Type
Device
Intervention Name(s)
Active PSIO
Intervention Description
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.
Primary Outcome Measure Information:
Title
Arch dimension (experimental group and control group)
Description
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.
Time Frame
T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)
Secondary Outcome Measure Information:
Title
Parents Perception and experience
Description
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.
Time Frame
T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)
Title
Linear measurement (experimental group and control group)
Description
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)
Time Frame
T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)
Title
Angular measurement (experimental group and control group)
Description
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
Time Frame
T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)
Title
Vertical measurement (experimental group and control group)
Description
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
Time Frame
T1 before starting any treatment and T2 After treatment before surgical repair (average 3 months)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Days
Maximum Age & Unit of Time
2 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Facility Information:
Facility Name
Mushreq Abed
City
Baghdad
State/Province
Al-Rusafa
ZIP/Postal Code
01110
Country
Iraq

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of a Newly Designed Presurgical Orthopedic Appliance

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