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Cleft PalateNCT05286398

Effect of Cleft Palate Repair Using Alveolar Extension Technique on Eruption and Growth

A study testing Palatoplasty and Addition silicone impression in people with Cleft Palate, run by Mansoura University at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study aimed to evaluate clinically the "Alveolar extension" technique for palatoplasty in cases of primary closure of cleft palate regarding its effect on: 1. Eruption of Primary dentition. 2. Maxillary primary teeth undergoing eruption. 3. The maxillary arch growth. Read more about this study

Who is it for?
Ages 9 to 14 monthsHealthy volunteers can take part
Conditions the study is for
Cleft Palate
What is being tested?
Palatoplasty and Addition silicone impression
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
16 participants
Where
1 siteEgypt
Study dates
22 Dec 2019to 16 Jan 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 9 to 14 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Both sexes.
  • The age range from 9-12 month.
  • Has a complete cleft palate.
  • Medically fit for general anesthesia.
  • Patients who haven't received any previous palatal repair.

Who cannot join

  • Syndromic patients.
  • Medically compromised patients contradicting operation.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Mansoura University

    Al Mansurah, Dakahliya, 35511

Other trials in Egypt

About this study

Official title: Effect of Cleft Palate Repair Using Alveolar Extension Technique on Primary Dentition and Maxillary Arch Width

This study aimed to evaluate clinically the "Alveolar extension" technique for palatoplasty in cases of primary closure of cleft palate regarding its effect on:

  1. Eruption of Primary dentition.
  2. Maxillary primary teeth undergoing eruption.
  3. The maxillary arch growth.
Read the detailed description

Cleft lip and palate represent the most common of the craniofacial anomalies. They are severe congenital malformations with a worldwide frequency ranging between 0.28 and 3.74 per 1000 live births. Cleft lip and palate occur in around 3 out of every 1000 infants in Egypt. Infants born with cleft palates always have eating difficulties due to a lack of oro-nasal seal and also have speaking difficulties due to velopharyngeal insufficiency. To ensure optimal care, the cleft team may include oral surgeons, plastic surgeons, pediatric dentists, orthodontists, and medical specialists in genetics, otolaryngology, pediatrics, and psychiatry. These caregivers evaluate the medical condition and development of the patient, as well as dental and oral health, facial esthetics, psychological condition, and developing of hearing and speech. Pediatric dentists are critical members of this team because they are responsible for the patient's overall dental health. A variety of dental anomalies and malocclusions are associated with cleft palate; these may occur as a result of primary defects being repaired surgically. The management of the cleft patient starts with an early focus on newborn's needs. Surgical repair of cleft palates (Palatoplasty) is typically performed by one year of age, primarily to facilitate the development of normal speech, as this coincides with the age at which the majority of children begin to speak. Hearing and swallowing are improved by proper alignment of the soft palatal musculature. The ideal palatoplasty technique is one that results in perfect speech without impairing maxillofacial growth or hearing. There are numerous surgical techniques for cleft palate repair, each with numerous variations. Nevertheless, a few of these techniques are widely used. Veau Wardill Kilner Palatoplasty, von Langenbeck, Bardach Two flap Palatoplasty were the most common techniques of palatoplasty. These techniques leave a large raw area along the alveolar margin, exposing bare bone. With secondary intention, the raw area heals. This results in palate shortening and velopharyngeal insufficiency. Additionally, the scar tissue adjacent to the alveolar margin results in deformity of the alveolar ridge and dental malalignment. It was found that lateral incision reduced the maxillary growth more than mucoperiosteal palatal detachment only. Additionally, some studies discovered that when matched normals are compared to individuals with unoperated clefts either lip or palate, the cranial base and skeletal face are not significantly malrelated. These findings suggest that cleft patient possess normal potential and mechanism of growth. The alveolar mucoperiosteum is deprived of blood supply from the facial artery in traditional lip repair procedures. Later, during palate repair, the palatal incisions isolate the palatal tissues from the greater palatine artery, altering the alveolar mucoperiosteum from a highly blood supplied zone between the two arteries into a tissue that is predominantly supported by osseous backflow. Thus, the disruption of palatal growth is considered in this perspective. The Alveolar Extension Palatoplasty (AEP) technique provide tension free flap, less palatal bone exposure after the surgery ,as the raw area is on the alveolar crest or tooth margin. It preserves blood supply of the palatal gingiva and periosteum. The studies on the influence of that advantage as well as the alveolar crest incision on unerupted primary teeth are scanty. So, it will be fruitful to study the effect of AEP on teeth undergoing eruption with alveolar bone and maxilla growth.

Conditions
Cleft Palate
Being tested
Palatoplasty, Addition silicone impression
Keywords
Alveolar extension palatoplasty, Bardach, Cleft palate
Medical subject headings
Cleft Palate

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PalatoplastyProcedure or surgery

    Surgical closure of palatal defect

  • Addition silicone impressionDiagnostic test

    diagnostic impression for maxillary arch

Study groups in NCT05286398
Study groupRoleWhat they receive
Control groupPlacebo comparatorNot described
Receives: Diagnostic Test: Addition silicone impression
Bradach groupExperimentalNot described
Receives: Procedure: Palatoplasty; Diagnostic Test: Addition silicone impression
AEP groupExperimentalNot described
Receives: Procedure: Palatoplasty; Diagnostic Test: Addition silicone impression

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. eruption of primary molars

    eruption of primay canine and primary first molar

    Measured: 6 month

Secondary outcomes (1)
  1. Growth

    maxillary arch width

    Measured: 6 monrth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2022
  2. Study start22 Dec 2019
  3. Primary completion1 Jan 2021
  4. Study completion16 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05286398
Sponsor's protocol ID
A09060819
Status last verified
Sep 2019
First submitted
7 Mar 2022
Last updated
23 Mar 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Palatoplasty and Addition silicone impression in people with Cleft Palate, run by Mansoura University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

eruption of primary molars (time frame: 6 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2022.

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