Evaluation of the Effect of Prosthetic Management for Congenital Cleft Lip and Palate Infants on the Middle Ear Function
Evaluation of the Effect of Prosthetic Management for Congenital Cleft Lip and Palate Infants on the Middle Ear Function: Clinical Trial
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Alexandria, Egypt, 21527
- Faculty of dentistry, Alexandria university
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Feeding appliance immediately after birth
|
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.
|
|
Experimental: Feeding appliance after 1-3 months
|
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.
|
|
Experimental: Feeding appliance after 4 -12 months
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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. |
up to one year of age
|
|
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 tympanograms were classified as normal, but types B and C were considered abnormal |
up to one year of age
|
|
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. |
up to one year of age
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- #111
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.