Alveolar CleftSABGNCT04845308
Radiographic Evaluation of Secondary Alveolar Bone Grafting in Patients With Alveolar Cleft
An observational study of Alveolar Cleft, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Study about the comparison of post-operative results of secondary alveolar grafts according to two age groups: early secondary (4 to 7 years) versus late secondary (8 to 11 years) using a recently proposed score based on post-operative 3D CT analysis. Read more about this study
- Who is it for?
- Ages 8 years and older
- Conditions the study is for
- Alveolar Cleft
- How many people
- 49 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2021to 30 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients operated with an alveolar bone grafting (taken from the anterior iliac crest ) for a single or bilateral labio-alveolar cleft in the pediatric plastic surgery department of the University Hospital of Montpellier between 1999 and 2021.
Who may be able to join
- Patients operated with an alveolar bone grafting for a single or bilateral labio-alveolar cleft in the pediatric plastic surgery department of the University Hospital of Montpellier between 1999 and 2021 and having had 3D imageries defined as:
- Group 1:
- o Patients operated with an early secondary alveolar grafting between the ages of 4 to 7 years with a 3D imaging (CT, CBCT or scan) performed between the ages of 8 to 11 years.
- Group 2:
- Patients operated with a late secondary alveolar graft between the ages of 8 to 11 years with a 3D imaging (CT, CBCT or scan) performed at least 1 year after the operation.
Who cannot join
- Patients operated with an alveolar bone grafting before 4 years or after 11 years
- Patients without post-operative CT
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 3D Radiographic Evaluation of the Long Terms Results of Secondary Alveolar Bone Grafting in Patients With Alveolar Cleft: Comparison of Early Versus Late Secondary Grafting SABG : Secondary Alveolar Bone Grafting
Study about the comparison of post-operative results of secondary alveolar grafts according to two age groups: early secondary (4 to 7 years) versus late secondary (8 to 11 years) using a recently proposed score based on post-operative 3D CT analysis.
Comparison of the initial results of the graft in the two groups, with a reference 2D score and evaluation of the concordance between the results found with this score and those of the 3D score.
Finally, comparison of graft bone densities and nasal floor level (using 3D visualization) on post-operative TDMs in the 2 groups.
The aim of this study is to determine the optimal age for grafting using three-dimensional CT assessment.
- Conditions
- Alveolar Cleft
- Keywords
- Secondary alveolar bone grafting, 3D score, Navigation system, 3D-reconstruction, Bone loss
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Patients operated with an early secondary alveolar grafting between the ages of 4 to 7 years with a 3D imaging (CT, CBCT or scan) performed between the ages of 8 to 11 years. | |
| Group 2 | Patients operated with a late secondary alveolar graft between the ages of 8 to 11 years with a 3D imaging (CT, CBCT or scan) performed at least 1 year after the operation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kamperos's score
Kamperos's score (a post-operative tri-dimensional scanographic score) This score includes 3 items measured on the post-operative CT: graft bone thickness (0 to 2), bone graft height (0 to 4) and nasal floor height (0 to 4).
A total score of 0 to 8 is considered a failure and 9 to 10 a success
Measured: Day 1
Secondary outcomes (3)
Bergland's score
Bergland's score (a post-operative two-dimensional radiographic score) Post-operative two-dimensional radiographic score : Use of the Bergland score (reference score).
This score evaluates the height of the inter-dental bone septum up to the cemento - enamel junction (1 to 4).
Measured: day 1
Post-operative average bone density of the grafted area in axial slice
Post-operative average bone density of the grafted area : in axial slice using radiological image processing software (Myrian®) to segment regions of interest.
Measured: day 1
Nasal floor level of the grafted side compared to the non grafted side using 3D visualization by volume rendering
Nasal floor level by analyzing the level of the piriform orifice in relation to the grafted area using 3D visualization by volume rendering: percentage of the height between the piriform orifice to the alveolar crest of the grafted side relative to the controlateral side (the healthy side considered as the reference 100% side).
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2021
- Study start1 Apr 2021
- Primary completion1 Jul 2021
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar CleftStudies 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
- 49 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
- NCT04845308
- Sponsor's protocol ID
- RECHMPL21_0190
- Acronym
- SABG
- Status last verified
- Oct 2021
- First submitted
- 10 Apr 2021
- Last updated
- 19 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 3D Radiographic Evaluation of the Long Terms Results of Secondary Alveolar Bone Grafting in Patients With Alveolar Cleft: Comparison of Early Versus Late Secondary Grafting SABG : Secondary Alveolar Bone Grafting
- ClinicalTrials.gov ID
- NCT04845308
- Acronym / sponsor ID
- SABG / RECHMPL21_0190
- Conditions
- Alveolar Cleft
- Keywords
- Secondary alveolar bone grafting, 3D score, Navigation system, 3D-reconstruction, Bone loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 14 Apr 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.
Study about the comparison of post-operative results of secondary alveolar grafts according to two age groups: early secondary (4 to 7 years) versus late secondary (8 to 11 years) using a recently proposed score based on post-operative 3D CT analysis.
Comparison of the initial results of the graft in the two groups, with a reference 2D score and evaluation of the concordance between the results found with this score and those of the 3D score.
Finally, comparison of graft bone densities and nasal floor level (using 3D visualization) on post-operative TDMs in the 2 groups.
The aim of this study is to determine the optimal age for grafting using three-dimensional CT assessment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –Patients operated with an early secondary alveolar grafting between the ages of 4 to 7 years with a 3D imaging (CT, CBCT or scan) performed between the ages of 8 to 11 years. |
| Group 2 | – | –Patients operated with a late secondary alveolar graft between the ages of 8 to 11 years with a 3D imaging (CT, CBCT or scan) performed at least 1 year after the operation. |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients operated with an alveolar bone grafting (taken from the anterior iliac crest ) for a single or bilateral labio-alveolar cleft in the pediatric plastic surgery department of the University Hospital of Montpellier between 1999 and 2021.
Key inclusion criteria (5 listed)
- Patients operated with an alveolar bone grafting for a single or bilateral labio-alveolar cleft in the pediatric plastic surgery department of the University Hospital of Montpellier between 1999 and 2021 and having had 3D imageries defined as:
- Group 1:
- o Patients operated with an early secondary alveolar grafting between the ages of 4 to 7 years with a 3D imaging (CT, CBCT or scan) performed between the ages of 8 to 11 years.
- Group 2:
Key exclusion criteria (2 listed)
- Patients operated with an alveolar bone grafting before 4 years or after 11 years
- Patients without post-operative CT
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Kamperos's score
Time frame: Day 1
Kamperos's score (a post-operative tri-dimensional scanographic score) This score includes 3 items measured on the post-operative CT: graft bone thickness (0 to 2), bone graft height (0 to 4) and nasal floor height (0 to 4). A total score of 0 to 8 is considered a failure and 9 to 10 a success
3 secondary outcomes
Bergland's score
Time frame: day 1
Post-operative average bone density of the grafted area in axial slice
Time frame: day 1
Nasal floor level of the grafted side compared to the non grafted side using 3D visualization by volume rendering
Time frame: day 1
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 19 Oct 2021.
- Individual participant dataSharing planned: Undecided. NC
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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.
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, 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 5 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 19 Oct 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 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?
Kamperos's score (time frame: Day 1). 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 19 Oct 2021.