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.
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.
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:
- Eruption of Primary dentition.
- Maxillary primary teeth undergoing eruption.
- 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 group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Not described Receives: Diagnostic Test: Addition silicone impression |
| Bradach group | Experimental | Not described Receives: Procedure: Palatoplasty; Diagnostic Test: Addition silicone impression |
| AEP group | Experimental | Not 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.
eruption of primary molars
eruption of primay canine and primary first molar
Measured: 6 month
Secondary outcomes (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.
- First posted18 Mar 2022
- Study start22 Dec 2019
- Primary completion1 Jan 2021
- Study completion16 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft PalateStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cleft Palate Repair Using Alveolar Extension Technique on Primary Dentition and Maxillary Arch Width
- ClinicalTrials.gov ID
- NCT05286398
- Acronym / sponsor ID
- A09060819
- Conditions
- Cleft Palate
- Keywords
- Alveolar extension palatoplasty, Bardach, Cleft palate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 22 Dec 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 16 Jan 2022 (actual)
- First posted
- 18 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to evaluate clinically the "Alveolar extension" technique for palatoplasty in cases of primary closure of cleft palate regarding its effect on:
- Eruption of Primary dentition.
- Maxillary primary teeth undergoing eruption.
- The maxillary arch growth.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Diagnostic Test: Addition silicone impression |
| Bradach group | Experimental | Procedure: Palatoplasty, Diagnostic Test: Addition silicone impression |
| AEP group | Experimental | Procedure: Palatoplasty, Diagnostic Test: Addition silicone impression |
Who may qualify
- Ages
- 9 to 14 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Syndromic patients.
- Medically compromised patients contradicting operation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PalatoplastySurgical closure of palatal defect | Procedure or surgery | AEP group, Bradach group |
| Addition silicone impressiondiagnostic impression for maxillary arch | Diagnostic test | AEP group, Bradach group, Control group |
Primary outcome
eruption of primary molars
Time frame: 6 month
eruption of primay canine and primary first molar
1 secondary outcome
Growth
Time frame: 6 monrth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.