search
Back to results

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

Primary Purpose

Cleft Palate

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Palatoplasty
Addition silicone impression
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cleft Palate focused on measuring Alveolar extension palatoplasty, Bardach, Cleft palate

Eligibility Criteria

9 Months - 14 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. Syndromic patients.
  2. Medically compromised patients contradicting operation.

Sites / Locations

  • Mansoura University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Control group

Bradach group

AEP group

Arm Description

Outcomes

Primary Outcome Measures

eruption of primary molars
eruption of primay canine and primary first molar

Secondary Outcome Measures

Growth
maxillary arch width

Full Information

First Posted
March 7, 2022
Last Updated
March 22, 2022
Sponsor
Mansoura University
search

1. Study Identification

Unique Protocol Identification Number
NCT05286398
Brief Title
Effect of Cleft Palate Repair Using Alveolar Extension Technique on Eruption and Growth
Official Title
Effect of Cleft Palate Repair Using Alveolar Extension Technique on Primary Dentition and Maxillary Arch Width
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
December 22, 2019 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
January 16, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mansoura 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cleft Palate
Keywords
Alveolar extension palatoplasty, Bardach, Cleft palate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Title
Bradach group
Arm Type
Experimental
Arm Title
AEP group
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Palatoplasty
Intervention Description
Surgical closure of palatal defect
Intervention Type
Diagnostic Test
Intervention Name(s)
Addition silicone impression
Intervention Description
diagnostic impression for maxillary arch
Primary Outcome Measure Information:
Title
eruption of primary molars
Description
eruption of primay canine and primary first molar
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Growth
Description
maxillary arch width
Time Frame
6 monrth

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Months
Maximum Age & Unit of Time
14 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Syndromic patients. Medically compromised patients contradicting operation.
Facility Information:
Facility Name
Mansoura University
City
Mansoura
State/Province
Dakahliya
ZIP/Postal Code
35511
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs