CompletedNot Applicable

Evaluation of the Efficiency of Bone Born Intra Oral Distractor for Closure of Wide Alveolar Cleft

Egypt8 participantsStarted 2023-03-14

Plain-language summary

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

Who can participate

Age range7 Years – 20 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change in alveolar cleft defect area measured by cone-beam computed tomography (CBCT) (minimum value: 0 mm²; no predefined maximum value; lower values indicate better outcome)

Timeframe: 6 months postoperative follow up

Change in tooth mobility assessed using Miller's Tooth Mobility Index (minimum score: 0; maximum score: 3; higher scores indicate worse mobility)

Timeframe: 6 months postoperative follow up

Vitality of the transported bone segment assessed by clinical vitality indicators after transport distraction osteogenesis (binary outcome: viable / non-viable; viable outcome indicates better result)

Timeframe: 6 months follow up

Trial details

NCT IDNCT07306429

SponsorFaculty of Dental Medicine for Girls

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2025-06-29

View on ClinicalTrials.gov More Alveolar Cleft trials