Cleft Lip and PalateNCT05002920
Correlation Between Body Mass Index and Progressive Grafted Bone in Cleft Patients
An observational study of Cleft Lip and Palate and Bone Graft; Complications, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The cleft patients received alveolar bone graft(ABG) for alveolar defect. Body mass index (BMI) was measured for each patients when receiving ABG. Bone mineral density was measured by Cone-Beam CT at two time-points: post-ABG six months, and post-ABG two years. Read more about this study
- Who is it for?
- Ages 8 to 10 years
- Conditions the study is for
- Cleft Lip and Palate, Bone Graft; Complications
- What is being tested?
- alveolar bone grafting
- Type of treatment
- Surgery or procedure
- How many people
- 39 participants
- Where
- 1 siteTaiwan
- Study dates
- 25 Jan 2021to 4 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 10 years
- All sexes
- No healthy volunteers
- Child
Study population: the patients with unilateral and bilateral cleft lip and palate received alveolar bone graft at their 9 year of age.
Who may be able to join
- nonsyndromic unilateral or bilateral cleft lip and alveolus with or without palate patients
- received secondary ABG at Chang Gung Craniofacial Center
- received team managements based on our current treatment protocol for cleft lip and palate
Who cannot join
- syndromic cleft
- patients with failed grafted tissue
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Correlation Between Body Mass Index and Progressive Bone Mineral Density in Cleft Patients After Secondary Alveolar Bone Grafting
The cleft patients received alveolar bone graft(ABG) for alveolar defect. Body mass index (BMI) was measured for each patients when receiving ABG. Bone mineral density was measured by Cone-Beam CT at two time-points: post-ABG six months, and post-ABG two years. The study was to analyze the correlation between BMI and post-operative bone mineral density.
Read the detailed description
Although childhood obesity is a growing issue, the association between BMI and the progressive bone mineral density (BMD) in grafted tissue after secondar alveolar grafting (ABG) remains little reviewed. This study compared the correlation between BMI and the progressive BMD after ABG procedure. Thirty-nine patients with unilateral or bilateral clefts were enrolled. ABG was performed at mixed-dentition age. Patient were classified into underweight, normal weight, and overweight or obese based on age- and sex-adjusted BMI. BMD was expressed in Hounsfield unit (HU) on cone-beam computed tomography (CBCT), which was obtained at 6 months (T1) and 2 years (T2) postoperatively. Calibrated BMD (HUgrafted tissue/HUpogonion¬, BMDc) was used for further analysis.
- Conditions
- Cleft Lip and Palate, Bone Graft; Complications
- Being tested
- alveolar bone grafting
- Keywords
- alveolar bone grafting, body mass index, bone mineral density, cone beam computed tomography
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alveolar bone graftingProcedure or surgery
the surgery of alveolar bone graft for alveolar defect in cleft patients
| Study group | Role | What they receive |
|---|---|---|
| cleft patients received alveolar bone grafting | alveolar bone grafting was performed when the cleft patients were aged around 9 years old. CBCT was used to analyze the bone mineral density of grafted tissue. Receives: Procedure: alveolar bone grafting |
What is being measured
The primary outcome is the main question the study is designed to answer.
bone mineral density
measuring the bone density from cone beam CT
Measured: post-ABG six months
bone mineral density
measuring the bone density from cone beam CT
Measured: post-ABG two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start25 Jan 2021
- Primary completion2 Jun 2021
- Study completion4 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Lip and PalateStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pangyunchou, Chang Gung Memorial Hospital
- Investigators
- Pangyun Chou, Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05002920
- Sponsor's protocol ID
- 201702342A3C501
- Status last verified
- Aug 2021
- First submitted
- 30 Jul 2021
- Last updated
- 12 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan shared.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Body Mass Index and Progressive Bone Mineral Density in Cleft Patients After Secondary Alveolar Bone Grafting
- ClinicalTrials.gov ID
- NCT05002920
- Acronym / sponsor ID
- 201702342A3C501
- Conditions
- Cleft Lip and Palate, Bone Graft; Complications
- Keywords
- alveolar bone grafting, body mass index, bone mineral density, cone beam computed tomography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- 25 Jan 2021 (actual)
- Primary completion
- 2 Jun 2021 (actual)
- Study completion
- 4 Jul 2021 (actual)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The cleft patients received alveolar bone graft(ABG) for alveolar defect. Body mass index (BMI) was measured for each patients when receiving ABG. Bone mineral density was measured by Cone-Beam CT at two time-points: post-ABG six months, and post-ABG two years. The study was to analyze the correlation between BMI and post-operative bone mineral density.
Detailed description
Although childhood obesity is a growing issue, the association between BMI and the progressive bone mineral density (BMD) in grafted tissue after secondar alveolar grafting (ABG) remains little reviewed. This study compared the correlation between BMI and the progressive BMD after ABG procedure. Thirty-nine patients with unilateral or bilateral clefts were enrolled. ABG was performed at mixed-dentition age. Patient were classified into underweight, normal weight, and overweight or obese based on age- and sex-adjusted BMI. BMD was expressed in Hounsfield unit (HU) on cone-beam computed tomography (CBCT), which was obtained at 6 months (T1) and 2 years (T2) postoperatively. Calibrated BMD (HUgrafted tissue/HUpogonion¬, BMDc) was used for further analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| cleft patients received alveolar bone grafting | – | Procedure: alveolar bone graftingalveolar bone grafting was performed when the cleft patients were aged around 9 years old. CBCT was used to analyze the bone mineral density of grafted tissue. |
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- the patients with unilateral and bilateral cleft lip and palate received alveolar bone graft at their 9 year of age.
Key inclusion criteria (3 listed)
- nonsyndromic unilateral or bilateral cleft lip and alveolus with or without palate patients
- received secondary ABG at Chang Gung Craniofacial Center
- received team managements based on our current treatment protocol for cleft lip and palate
Key exclusion criteria (2 listed)
- syndromic cleft
- patients with failed grafted tissue
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| alveolar bone graftingthe surgery of alveolar bone graft for alveolar defect in cleft patients | Procedure or surgery | cleft patients received alveolar bone grafting |
Primary outcome
bone mineral density
Time frame: post-ABG six months
measuring the bone density from cone beam CT
bone mineral density
Time frame: post-ABG two years
measuring the bone density from cone beam CT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2021.
- Individual participant dataSharing planned: No. no plan shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pangyun Chou principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cleft Lip and Palate and Bone Graft; Complications, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
bone mineral density (time frame: post-ABG six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2021; AzTrials last refreshed its copy on 30 Oct 2026.