Evaluation of the Effect of Prosthetic Management for Congenital Cleft Lip and Palate Infants on the Middle Ear Function
Primary Purpose
Cleft Lip and Palate
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Feeding appliance
Sponsored by
About this trial
This is an interventional treatment trial for Cleft Lip and Palate
Eligibility Criteria
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/
Sites / Locations
- Faculty of Dentistry, Alexandria University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Feeding appliance immediately after birth
Feeding appliance after 1-3 months
Feeding appliance after 4 -12 months
Arm Description
Outcomes
Primary Outcome Measures
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.
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
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT06075069
Brief Title
Evaluation of the Effect of Prosthetic Management for Congenital Cleft Lip and Palate Infants on the Middle Ear Function
Official Title
Evaluation of the Effect of Prosthetic Management for Congenital Cleft Lip and Palate Infants on the Middle Ear Function: Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
May 10, 2023 (Actual)
Study Completion Date
May 10, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Lip and Palate
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Feeding appliance immediately after birth
Arm Type
Experimental
Arm Title
Feeding appliance after 1-3 months
Arm Type
Experimental
Arm Title
Feeding appliance after 4 -12 months
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Feeding appliance
Intervention Description
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 Outcome Measure Information:
Title
Assessment of middle ear pressure
Description
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.
Time Frame
up to one year of age
Title
Assessment of middle ear compliance
Description
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
Time Frame
up to one year of age
Title
Assessment of hearing quality
Description
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.
Time Frame
up to one year of age
10. Eligibility
Sex
All
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
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/
Facility Information:
Facility Name
Faculty of Dentistry, Alexandria University
City
Alexandria
ZIP/Postal Code
21527
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Effect of Prosthetic Management for Congenital Cleft Lip and Palate Infants on the Middle Ear Function
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