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Completed

NCT Number: NCT06075069

Evaluation of the Effect of Prosthetic Management for Congenital Cleft Lip and Palate Infants on the Middle Ear Function

Aim of the study was to evaluate the effect of feeding appliance for congenital cleft lip and palate infants on the middle ear function

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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

Up to 1 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Alexandria University

Alexandria, 21527, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Infants with bilateral cleft lip and palate.
  • Centralized pre-maxilla that does not need active appliance.
  • Normal inner ear and auditory nerve function.

Exclusion criteria

  • Infant with unilateral cleft lip and palate or cleft palate only.
  • Deviated pre-maxilla that needs active appliance.
  • Congenital hearing problems or sensorineural hearing loss/

Treatment and study plan

Feeding appliance

Device

A preliminary alginate impression was made using wax stock tray to get a preliminary cast and construct a self-cure acrylic custom-made tray. A Medium viscosity rubber base impression material was used for making final impression which in turn will be poured to obtain a master cast. On this master cast, a feeding appliance will be constructed. Readymade facebow with two straight side length of hard, rounded, of 2mm diameter, 15cm length Nickel-Chrome wire with omega loops (at the end of the wire) was used to form extra-oral wings to be used as a retentive aid to maintain the prosthesis in situ. The appliance was fabricated in clear acrylic resin then finished and polished. A small piece of cold cure acrylic resin was added and adapted to the omega loops and manipulated to follow the checks contour.

Primary outcomes

  1. Assessment of middle ear pressure

    Time frame: up to one year of age

    This was performed using Tympanometer that measures the air pressure in the middle ear to obtain Tympanogram which is a graphic representation of how the eardrum moves in response to the air pressure in the ear canal. Tympanometry was performed using a AT235 tympanometer with a 226-Hz probe frequency. It was calibrated to ANSI standards (American National Standards Institute,1987).

    The normal middle-ear pressure values for children are +50 daPa to -200 daPa.

  2. Assessment of middle ear compliance

    Time frame: up to one year of age

    This was performed using Tympanometer.

    The patients' tympanometric results were classified into three types:

    • Type A: Static compliance greater than 0.1 ml and the point of greatest compliance is at approximately 0 daPa; the curve is shown by a large, inverted V. In a "type A" curve, the peak compliance occurs at or near atmospheric pressure indicating normal pressure within the middle ear.
    • Type B: The point of greatest compliance cannot be found, and the curve is shown by a flat curve (no peak). This is indicative of non-compressible fluid within the middle ear space (otitis media), tympanic membrane perforation, or debris within the external ear canal.
    • Type C: Static compliance greater than or equal to 0.2 ml, and the peak compliance is significantly below zero (usually less than -200), indicating negative pressure (sub-atmospheric) within the middle ear space.

    Type A tympanograms were classified as normal, but types B and C were considered abnormal

  3. Assessment of hearing quality

    Time frame: up to one year of age

    Audiometric screening will be performed using Auditory brainstem response (ABR) conducted under natural sleep as far as possible. ABR can provide information about the softest level of sound the ear can hear. It is traditionally used to determine the degree of hearing loss in pediatrics.

    ABR test uses electrodes attached with adhesive to the baby's scalp. While the baby is sleeping, clicking sounds were made through headphones over the baby's ears. The test measures the brain's activity in response to the sounds.

    Hearing level thresholds as estimated by ABR are categorized as normal (25 - 35 dB nHL), mild (35 - 45 dB nHL), moderate (45 - 65 dB nHL), severe (65 - 90 dB nHL), and profound (90 dB nHL) hearing loss.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

Evaluation of the Effect of Prosthetic Management for Congenital Cleft Lip and Palate Infants on the Middle Ear Function: Clinical Trial

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 10, 2023
Registry last updated
Oct 10, 2023

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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