Primary Objective: The hypothesis of this study is that an Obwegeser Dal Pont splitting procedure with a well- defined inferior border osteotomy needs less torque to split the mandible than the traditional technique.Secondary Objectives: Using the…
ID
Source
Brief title
Condition
- Head and neck therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary objective of the study is measurement of the required torque [Nm]
that is needed to split the mandible and which is recorded during operation.
Minor forces mean a beter prefabricated split and less chiseling by the
surgeon.
Secondary outcome
Classification of the lingual fracture line by postoperative cone beam computed
tomography into four classes: Fracturing according to Hunsuck (class I),
fracturing according to Obwegeser (class II), fracturing along the mandibular
canal (class III) and unfavourable fracture (bad split, class IV).
Postoperative long-term sensibility of the lip, chin and oral mucosa, which is
innervated by the inferior-alveolar nerve (Prick test, two point
discrimination, thermal testing)
Background summary
Patients with a severe congenital deviation of the mandible often undergo
correction surgery. Therefore the mandible needs to be broken en to be
refixated in the correct position. The routine procedure and the worldwide
standard for this procedure is the sagittal split osteotomy (SSO). Hereby the
mandible is fractured in sagittal direction. Afterwards it is repositioned and
then fixated with mini-plates and -screws. Although being a highly rewarded
technique, complications such as damage to the inferior alveolar nerve (IAN) or
as a fracture in an unfavourable way (bad splits) are still common.
Study objective
Primary Objective: The hypothesis of this study is that an Obwegeser Dal Pont
splitting procedure with a well- defined inferior border osteotomy needs less
torque to split the mandible than the traditional technique.
Secondary Objectives: Using the modified technique the split is more precise
than with the traditional sagittal splitting procedure by Obwegeser- Dal Pont.
Damage like neurapraxia, axonotmesis or neurotmesis of the inferior alveolar
nerve (IAN) will be lower when the modified technique is used.
Study design
This is a pilot randomized controlled clinical trial with a split mouth study
design to compare the efficacy of two different techniques for splitting the
mandible. After obtaining informed consent, patients who need a BSSO operation
will enrol in the study. The estimated duration of this study from first intake
till last follow-up is about 6 months.
The procedure will take place under general anaesthesia, like in the routine
procedure. The procedure consists of a sagittal split osteotomy of the mandible
according to Obwegeser- Dal Pont on the one side and of a sagittal split
osteotomy with a well-defined inferior border osteotomy on the other side. The
osteotome that is used for the spitting is attached to a gauge and the applied
forces are recorded.
Intervention
The sagittale split osteotomy is the worldwide standard to fracture the
mandible for orthognathic reasons since 1954. It is outlined in the next
paragraph: First the mandibular ramus and the mandibular body are identified as
well as the lingula with the entering IAN. The osteotomy starts with the
horizontal cut of the medial cortex of the ramus above the lingula under
protection of the IAN, followed by the vertical cut of the buccal cortex of the
mandibular body about the submandibular notch. The third osteotomy is the
connection of the first two ones along the oblique line. Chiselling starts and
it deepens the cut along the buccal cortex. After completion the effective
splitting procedure begins. An osteotome is placed inside the split and it is
torqued in order to separate the ramus part from the teeth bearing part .(A)
If some resistance in the splitting occurs chiselling has to be deepened, often
below the IAN involving the risk of its damage.
The condyle with the ramus part and the teeth bearing part of the mandible are
separated if the split is successfully completed.
The same procedure takes place at the contralateral side. Now the mandible is
fractured and the occlusion can be adjusted. Then the fracture is fixated by
osteosynthesis.
The modification of the procedure takes place at point (A). An additional cut
is placed at the inferior border of the mandible about the submandibular notch
towards the mandibular angle. This step spares the part of deeper chiselling
during the splitting.
Study burden and risks
The benefit of participating in this study is the smaller risk of mayor
sequellae of the SSO such as unfavourable splitting or damage to the
infra-alveolar nerve.
The risk associated with participation in this study is more extend
post-operative swelling due to the risk of creating more space to place the saw
for the inferior border cut.
The patient must visit the clinic as often as for a standard treatment. No
extra visits or additional x-rays are needed.
P. Debyelaan 25
Maastricht 6229 HX
NL
P. Debyelaan 25
Maastricht 6229 HX
NL
Listed location countries
Age
Inclusion criteria
18-50 years old
Skeletal occlusion Angle class II or III needed a surgical correction by sagittal split osteotomy.
Exclusion criteria
Contraindications for general anaesthesia
Treated with bisphosphonates
Uncontrolled diabetes
Pregnancy
Infection
High risk of bleeding
Revision surgery
Patients under guardianship
Syndromal patients such as patients with e.g. Apert syndrome, Crouzon syndrome, hemifacial microsomia, Goldenhaar syndrome, fibrous dysplasia
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL54299.068.15 |
| OMON | NL-OMON29307 |