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 range

7 Years – 20 Years

Sex

ALL

See this in plain English?

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

7 Years – 20 Years

Sex

ALL

See this in plain English?

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

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

Timeframe: 6 months follow up