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

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

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

Conditions
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Cleft Lip and Palate

Intervention / Treatment
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* Device: Feeding appliance


Participation Criteria
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Eligibility Criteria
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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/

Ages Eligible for Study
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Maximum Age: 1 Year

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Feeding appliance immediately after birth<br> | Device: Feeding appliance<br>* 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.<br>|
| Experimental: Feeding appliance after 1-3 months<br> | Device: Feeding appliance<br>* 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.<br>|
| Experimental: Feeding appliance after 4 -12 months<br> | Device: Feeding appliance<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of middle ear pressure | 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. | up to one year of age | 
| Assessment of middle ear compliance | 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 | up to one year of age | 
| Assessment of hearing quality | 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. | up to one year of age |