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

NCT ID: NCT05286398

Last Updated: 2022-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-12-22
• Study Completion Date: 2022-01-16

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:

1. Eruption of Primary dentition.

2. Maxillary primary teeth undergoing eruption.

3. 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.

Conditions

Cleft Palate

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control group

Group Type: PLACEBO_COMPARATOR

Addition silicone impression

Intervention Type: DIAGNOSTIC_TEST

diagnostic impression for maxillary arch

Bradach group

Group Type: EXPERIMENTAL

Palatoplasty

Intervention Type: PROCEDURE

Surgical closure of palatal defect

Addition silicone impression

Intervention Type: DIAGNOSTIC_TEST

diagnostic impression for maxillary arch

AEP group

Group Type: EXPERIMENTAL

Palatoplasty

Intervention Type: PROCEDURE

Surgical closure of palatal defect

Addition silicone impression

Intervention Type: DIAGNOSTIC_TEST

diagnostic impression for maxillary arch

Interventions

Palatoplasty

Surgical closure of palatal defect

Intervention Type: PROCEDURE

Addition silicone impression

diagnostic impression for maxillary arch

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 9 Months
• Maximum Eligible Age: 14 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Mansoura University

Al Mansurah, Dakahliya, Egypt

Countries

Egypt

Other Identifiers

A09060819

Identifier Type: -

Identifier Source: org_study_id