CompletedNot Applicable

Progression of Grafted Bone Density in Cleft Alveolus

Taiwan40 participantsStarted 2021-01-25

Plain-language summary

The patients with unilateral and bilateral cleft lip and palate received alveolar bone graft surgery. Two time points of cone beam CT were taken for all the patients: post-operative 6 months, and post-operative 2 years. All the CT images were reviewed for the analysis of grafted bone density.

Who can participate

Age range

8 Years – 10 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 who had nonsyndromic unilateral or bilateral cleft lip and alveolus with or without cleft palate * Patients received alveolar bone graft at their 9 years of age * Patients received twice CBCT after the surgery Exclusion Criteria: * Patient had syndromic cleft alveolus * Patient underwent two-stage ABG (performed for bilateral cases) * Patient exhibited failed grafted tissue

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

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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

mean calibrated bone mineral density (BMD/pogonion density, BMDc)

Timeframe: 1st BMD at post-operative 6 months

mean calibrated bone mineral density (BMD/pogonion density, BMDc)

Timeframe: 2nd BMD at post-operative 2 years

Trial details

NCT IDNCT04987190

SponsorChang Gung Memorial Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-06-02

View on ClinicalTrials.gov More Cleft Lip and Palate trials

Who can participate

Age range

8 Years – 10 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.