Alveolar Cleft Operated on an Alveolar Bone GraftNCT03883373
Alveolar Bone Graft Cortical Nasal Floor
An observational study of Alveolar Cleft Operated on an Alveolar Bone Graft, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Alveolar bone graft is one of the main step of the surgical care of the patients who are suffering from cleft lip and palate. They are usually performed before the lateral incisor eruption, at about 5 years old and using cancellous bone taken from the iliac crest. Read more about this study
- Who is it for?
- Ages 3 to 20 years
- Conditions the study is for
- Alveolar Cleft Operated on an Alveolar Bone Graft
- What is being tested?
- alveolar bone graft with cancellous bone and a cortical block and alveolar bone graft with cancellous bone only
- Type of treatment
- Surgery or procedure
- How many people
- 302 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jun 1999to 1 Mar 2019
- 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 3 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients who are suffering from clef lip and palate or alveolar cleft and had to have an alveolar bone graft with gingivo-periostoplasty in the pediatric plastic surgery unit of the Montpellier hospital from June 1999 to Mai 2016
Who may be able to join
- Patients with a clef lip and palate or alveolar cleft
- Grafted in the Montpellier pediatric surgery unit from june 1999 to mai 2016
- Followed during 6 months of post operative follow up
Who cannot join
- No post operative follow up
- other alveolar bone graft in the past medical history
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Alveolar Bone Graft With Only Cancellous Bone, and Alveolar Bone Graft With Cancellous Bone Combined With Nasal Cavity Floor's Reconstruction Using a Cortical Block
Alveolar bone graft is one of the main step of the surgical care of the patients who are suffering from cleft lip and palate. They are usually performed before the lateral incisor eruption, at about 5 years old and using cancellous bone taken from the iliac crest.
The aim of the study is to show if adding a cortical graft to the cancellous cause more complications, which may be source of partial or total graft loss in the 6 month following the observation
Read the detailed description
This is an observational, retrospective and monocentric study. To be included, patients had to suffer from a clef lip and palate or alveolar cleft and had to have an alveolar bone graft with gingivo-periosteoplasty in the pediatric plastic surgery unit of the Montpellier hospital from June 1999 to Mai 2016. They were divided into two groups : the first with patients who had a cortical and cancellous bone graft and the second with patients who had a cancellous graft only.
Both groups were followed 6 mounts after the operation to look for the occurence of complications which lead to a graft loss. Bilateral cleft are seen as 2 graft events
- Being tested
- alveolar bone graft with cancellous bone and a cortical block, alveolar bone graft with cancellous bone only
- Keywords
- alveolar graft, cancellous bone, cortical block, nasal floor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alveolar bone graft with cancellous bone and a cortical blockProcedure or surgery
alveolar bone graft with cancellous bone only
alveolar bone graft with cancellous bone onlyProcedure or surgery
alveolar bone graft with cancellous bone only
| Study group | Role | What they receive |
|---|---|---|
| Cortical group | Group of patient who had an alveolar bone graft with cancellous bone and a cortical block Receives: Procedure: alveolar bone graft with cancellous bone and a cortical block | |
| Cancellous group | Group of patient who had an alveolar bone graft with cancellous bone only Receives: Procedure: alveolar bone graft with cancellous bone only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication events
Analyze retrospective of the electronic medical record was made as followed: read of peri-operative and post-operative reports, looking for complications during the 6 months of post operative follow up
Analyze of the electronic medical record was made as followed: read of peri-operative and post-operative reports, looking for readmission in Pediatric Emergency department and finally read of the report of the clinical control 1 month after the procedure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2019
- Study start1 Jun 1999
- Primary completion1 May 2016
- Study completion1 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Cleft Operated on an Alveolar Bone GraftStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume CAPTIER, MD.PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03883373
- Sponsor's protocol ID
- RECHMPL19_0136
- Status last verified
- Mar 2019
- First submitted
- 18 Mar 2019
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Alveolar Bone Graft With Only Cancellous Bone, and Alveolar Bone Graft With Cancellous Bone Combined With Nasal Cavity Floor's Reconstruction Using a Cortical Block
- ClinicalTrials.gov ID
- NCT03883373
- Acronym / sponsor ID
- RECHMPL19_0136
- Keywords
- alveolar graft, cancellous bone, cortical block, nasal floor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Jun 1999 (actual)
- Primary completion
- 1 May 2016 (actual)
- Study completion
- 1 Mar 2019 (actual)
- First posted
- 20 Mar 2019 (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.
Alveolar bone graft is one of the main step of the surgical care of the patients who are suffering from cleft lip and palate. They are usually performed before the lateral incisor eruption, at about 5 years old and using cancellous bone taken from the iliac crest.
The aim of the study is to show if adding a cortical graft to the cancellous cause more complications, which may be source of partial or total graft loss in the 6 month following the observation
Detailed description
This is an observational, retrospective and monocentric study. To be included, patients had to suffer from a clef lip and palate or alveolar cleft and had to have an alveolar bone graft with gingivo-periosteoplasty in the pediatric plastic surgery unit of the Montpellier hospital from June 1999 to Mai 2016. They were divided into two groups : the first with patients who had a cortical and cancellous bone graft and the second with patients who had a cancellous graft only.
Both groups were followed 6 mounts after the operation to look for the occurence of complications which lead to a graft loss. Bilateral cleft are seen as 2 graft events
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cortical group | – | Procedure: alveolar bone graft with cancellous bone and a cortical blockGroup of patient who had an alveolar bone graft with cancellous bone and a cortical block |
| Cancellous group | – | Procedure: alveolar bone graft with cancellous bone onlyGroup of patient who had an alveolar bone graft with cancellous bone only |
Who may qualify
- Ages
- 3 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients who are suffering from clef lip and palate or alveolar cleft and had to have an alveolar bone graft with gingivo-periostoplasty in the pediatric plastic surgery unit of the Montpellier hospital from June 1999 to Mai 2016
Key inclusion criteria (3 listed)
- Patients with a clef lip and palate or alveolar cleft
- Grafted in the Montpellier pediatric surgery unit from june 1999 to mai 2016
- Followed during 6 months of post operative follow up
Key exclusion criteria (2 listed)
- No post operative follow up
- other alveolar bone graft in the past medical history
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 graft with cancellous bone and a cortical blockalveolar bone graft with cancellous bone only | Procedure or surgery | Cortical group |
| alveolar bone graft with cancellous bone onlyalveolar bone graft with cancellous bone only | Procedure or surgery | Cancellous group |
Primary outcome
Complication events
Time frame: 6 months
Analyze retrospective of the electronic medical record was made as followed: read of peri-operative and post-operative reports, looking for complications during the 6 months of post operative follow up Analyze of the electronic medical record was made as followed: read of peri-operative and post-operative reports, looking for readmission in Pediatric Emergency department and finally read of the report of the clinical control 1 month after the procedure
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 2019.
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.
Guillaume CAPTIER, MD.PhD study director
University Hospital, Montpellier
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 Alveolar Cleft Operated on an Alveolar Bone Graft, run by University Hospital, Montpellier at 1 site in France.
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 2019. 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 France. 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?
Complication events (time frame: 6 months). 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 2019.