The main objective is to improve predictability of orthognatic surgery, or in other words to realise a stronger relation between (3D virtual) pre-operative planning and post-operative result. The second objective is to evaluate the surgeon*s…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Dysgnate afwijking
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint for this study is the geometrical change on dentition
level. The baseline is the planned position, compared with the post-operative
final position. CBCT*s of the maxillofacial region will be made according to
care as usual in our clinic which implicates: 1 pre-operative series with
dental impression paste, 6-10 days post-operative, and 1 year post-operative.
Secondary outcome
Secondary Objective(s): Is the application of patient specific osteosynthesis
contributive to or at least non inferior to the surgeons* satisfaction? This
will be registered with a standardized comparative questionnaire after each
surgery, completed by the surgeon. This questionnaire will register the user
friendly ness, number of switches to conventional osteosynthesis and reasons
for switching to conventional osteosynthesis. Also the mid-long term evaluation
(1 year post-op) provides information regarding bony relapse. The amount of
relapse is compared between both groups. The measurements are performed
identical to the direct post-op evaluation analysis
Background summary
In orthognatic surgery, patients with a dysgnatic deformity are operated to
correct their functional and esthetical problems. The surgery usually includes
an osteotomy and translocation of the upper and/or lower jaw. Currently,
orthognatic treatment planning is performed in 3D with virtual planning
software, based on 3D medical imaging (e.g., Cone-Beam CT images). The planning
is communicated to the surgical intervention by the use of a through a 3D
printed/milled splint with the imprint of the dentition. This splint dictates
the translation of the jaw during the surgical procedure, as it contains the
original position of one jaw (e.g. lower) and the newly planned position of the
antagonist jaw (e.g. the upper). In the new position of the jaws as determined
by the splint, the continuity of the jaw is restored by screw fixation of small
osteosynthesis plates. These osteosynthesis plates are bended intra-operative
to achieve a passively fit to the jaw fragments at the osteotomy sites in the
correct position. This method is proven to be reliable, but it will not always
provide full control over the translation of the upper jaw. To overcome this
unpredictable control , a new method of communicating the 3D virtual planning,
meaning the planned jaw position, towards the surgical intervention, was
designed. By using CAD/CAM milled, pre-shaped, patient specific fixation plates
the translation of the 3D plan to the patient surgery is hypothetically more
precise and providing increased control over translocation of the jaw, compared
to the use of a conventional splint. This is explained, as no manual bending of
the fixation plates during surgery is necessary with this method. Also the
pre-shaped plates will support the upper jaw in 3 dimensions during the
fixation, which increases control over the translocation of the jaw fragments
after the osteotomy. In order to place the patient specific plates on the
planned location, a set of drill and cutting guides, also supported on the
dentition is used. These should translate planned position of screws and plates
to the jaw.
In this study the conventional method, using 3D planning and a 3D milled splint
is compared to the new method with patient specific osteosynthesis, applied in
the upper jaw in a randomised controlled trial.
Study objective
The main objective is to improve predictability of orthognatic surgery, or in
other words to realise a stronger relation between (3D virtual) pre-operative
planning and post-operative result. The second objective is to evaluate the
surgeon*s satisfaction in terms of placement comfort and user friendliness in
both groups.
Study design
In order to test the difference in accuracy of translation of the 3D virtual
planning and predictability of outcome, this study requires a randomised
controlled prospective trial design. Where the control group will receive
conventional 3D virtual planning and translation (3D splints) and the
intervention group will receive the patient specific osteosynthesis material in
order to translate the 3D planning.
Intervention
The intervention in this study is an osteotomy of the upper jaw. The
translation of 3D virtual pre-operative planning to the surgery of the upper
jaw in the operating theatre with the patient specific fixation plates and
surgical guides compared to care as usual with a 3D milled splint dictating the
translation. Followed by 3D post-operative position accuracy-analysis compared
to the virtual plan.
Study burden and risks
The surgical procedure will not be subject to substantial changes for the
patient. No other surgical approach is needed, no larger incisions will be made
and no differences in the used materials are planned. The patient specific
fixation plates are fabricated out of CE-medical grade (V) titanium by an
ISO13485 and ISO 9001:2008 certified manufacturer (Createch Medical, Mendaro
Spain). The surgical guides are fabricated out of a plastic (nylon), which is
sterilisation proof, frequently used in surgeries. No additional materials are
used in the surgical procedure, despite the method that is used (conventional
or patient specific). As an escape procedure, in case of the patient specific
osteosynthesis, the regular 3D milled splint is made for every patient as well.
The regular titanium osteosynthesis can thereby be applied at any time if the
circumstances require this. Examples would be: non-fitting pre-fabricated
plates, contamination of the plates during surgery, logistic problems, etc.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
• Patients are awaiting orthognatic surgical treatment, namely: Le Fort I osteotomy (upper jaw) as part of their treatment plan.;• A dorsal down graft of the maxilla, or upper jaw, must be part of the planned translocation. ;• Patients are susceptible to 3D virtual planning of their surgical intervention, e.g. their mouth opening must be sufficient for gathering a dental imprint of both upper and lower jaw at the same time. This will not require a large opening, however, when suffering from trismus it can be problematic to gather the double imprint. At least 40mm of mouth opening is usually required to gather the dentition imprint information.;• The patient is at least 18 years of age. Completion of physical growth is a routine criterion for orthognatic surgery.
Exclusion criteria
• Patient does not agree to randomised application of osteosynthesis method;• Patient is, for any reason, not able to undergo the 3D virtual planning procedure, including double dentition imprints, pre-operative CBCT scanning and virtual planning of translations. An example could be the inability to complete the dental imprint of both upper and lower jaw, or inadequate scanning of the patient. These examples will, if applicable, come up during the preparation appointment with the patient, and therefore not delay the patients trajectory.;• Pregnancy, which is a general contraindication for orthognatic surgery.;• Allergy to titanium, which would mean a general exclusion for orthognatic surgery
Design
Recruitment
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 | NL52330.042.15 |