Evaluation of the Efficiency of Bone Born Intra Oral Distractor for Closure of Wide Alveolar Cleft (BBID-WAC)

Faculty of Dental Medicine for Girls

Status: Completed

Conditions: Alveolar Cleft; Distraction of Bone

Treatments: Device: Bone-borne Intra oral distractor

Study type: Interventional

Funder types: Other

Identifiers

NCT07306429

ORSUR-10

Details and patient eligibility

About

The study aimed to determine efficiency of Bone-Born Intraoral Distractor on wide Alveolar cleft patients

Full description

Stereographic models were used for construction of bone-born custom-made intraoral distractor according to the inclusion and exclusion criteria, followed up to measure and determine the efficiency of the distractor

Enrollment: 8 patients

Sex: All

Ages: 7 to 20 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with wide alveolar clefts more than 8ml either unilateral or bilateral or median facial cleft.
• Patients who had previous failed grafting also may be included.
• Age range of patients 7-20 years old, with no gender prediction, able to read and sign the informed consent (parents)
• Patients with median facial clefts.

Exclusion criteria

• Narrow alveolar cleft
• Syndromic patients.
• Oral soft tissues defects, inflammation, infections and bone metabolism disturbance.
• Allergy to titanium implant.
• Patient with systemic disease and immunocompromised patient.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Bone-Borne Intra-oral distractor

Experimental group

Description:

Surgeries to fix the device were conducted under GA. Then latency period of seven days was applied. Activation was 0.5 mm twice a day. The transport segment touched the docking site then the Consolidation period is achieved. Follow up for 6 months.

Treatment:

Device: Bone-borne Intra oral distractor