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

Not Applicable

Completed

• Conditions: Cleft Lip and Palate
• Interventions: Device: Feeding appliance

• Registration Number: NCT06075069
• Lead Sponsor: Alexandria University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-01
• Primary Completion: 2023-05-10
• Study Completion: 2023-05-10
• Status Verified: 2023-10
• Study First Submitted: 2023-10-04
• Study First Submitted QC: 2023-10-04
• Last Update Submitted: 2023-10-04
• Study First Posted: 2023-10-10
• Last Update Posted: 2023-10-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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/

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Feeding appliance after 1-3 months	Feeding appliance	-
Feeding appliance after 4 -12 months	Feeding appliance	-
Feeding appliance immediately after birth	Feeding appliance	-

Primary Outcome Measures

Name	Time	Method
Assessment of middle ear pressure	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.
Assessment of middle ear compliance	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
Assessment of hearing quality	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.

Trial Locations

Locations (1)

Faculty of Dentistry, Alexandria University; 🇪🇬 Alexandria, Egypt