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NCT Number: NCT05535530

The Effect of a Newly Designed Presurgical Orthopedic Appliance

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.

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Key information

Conditions

Cleft Lip and Palate Cleft Lip Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Lip Diseases Mouth Abnormalities Mouth Diseases Stomatognathic Diseases Stomatognathic System Abnormalities

Age range

5 day–2 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mushreq Abed

Baghdad, Al-Rusafa, 01110, Iraq

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Active PSIO

Device

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 outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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)

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

University of Baghdad

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 10, 2022
Registry last updated
Sep 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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