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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Feeding appliance immediately after birth | Experimental |
| |
| Feeding appliance after 1-3 months | Experimental |
| |
| Feeding appliance after 4 -12 months | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Alexandria University | Alexandria | 21527 | Egypt |
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| ID | Term |
|---|---|
| D002971 | Cleft Lip |
| ID | Term |
|---|---|
| D008047 | Lip Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D009056 | Mouth Abnormalities |
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|
| up to one year of age |
| D018640 |
| Stomatognathic System Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |