This current study aims to investigate the use of Curios bèta-TCP, a synthetic tricalcium phosphate for repair of the alveolar cleft in patients with clefts of lip, alveolus and palate.The specific properties of Progentix TCP result in optimal and…
ID
Source
Brief title
Condition
- Other condition
- Congenital and hereditary disorders NEC
- Head and neck therapeutic procedures
Synonym
Health condition
cheilognathopalatoschisis
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The outcome of the study will be the difference (%) in volumetrically (cubic
mm) assessed bone volume compared to the original volume of the alveolar cleft.
Secondary outcome
not applicable
Background summary
At the age of 9-11 years patients with cleft of lip, alveolus and palate will
undergo bonegrafting surgery in order to close the alveolar cleft with
autologous chin bone or with iliac crest bone before orthodontic interference
takes place. These harvest sites require a second additional surgical procedure
with risk of primary and secondary complications. Therefore the use of a
synthetic, osteoinductive material seems a logical step forward.
Study objective
This current study aims to investigate the use of Curios bèta-TCP, a synthetic
tricalcium phosphate for repair of the alveolar cleft in patients with clefts
of lip, alveolus and palate.
The specific properties of Progentix TCP result in optimal and predictable bone
regeneration as also proven in the human situation.
The objectives are:
-Complete closure of the alveolar cleft with bone
-Eruption of teeth as well as guidance by orthodontic interference of these
teeth into the newly formed bone must be possible
Study design
-indication for grafting the alveolar cleft in the patient with cleft of lip,
alveolus and palate at the age of 9-11 years, set by the orthodontist and the
oral surgeon. Usually the decisive moment for surgery depends on the
developmental stage of the upper canine root.
-taking 3-D CBCT scans with collimator immediately before and after the
surgical harvesting/grafting-procedure and six and twelve months
postoperatively.
-assessment of volumetric measurements from these scans.
-statistics.
Intervention
In all participants in this study the bèta-TCP will be used as a filler of the
prepared recipient site in the alveolar cleft.
The outcome of this study, volumetric bone volume, will be compared to the
original volume of the alveolar cleft.
As control group will serve the patient group from Van der Meij's thesis, 2005
Amsterdam, who determined a standard of 70% for bone volume necessity.
Study burden and risks
not applicable
Heidelberglaan 100
3584 CX U T R E C H T
NL
Heidelberglaan 100
3584 CX U T R E C H T
NL
Listed location countries
Age
Inclusion criteria
Children with cleft of lip, alveolus and palate with radiological proof of half-developmental stage of the root of the upper canine or a viable lateral incisor
Exclusion criteria
No cleft of lip, alveolus and palate.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL27084.041.09 |