Research with human participants

Overview of medical research in the Netherlands

advancement of the mandible by bilateral sagital spit osteotomy and distraction osteogenesis; a randomised clinical trial

Published:
Last updated:

To evaluate the two procedures for lengthening of the mandible.

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Ethical review
Approved WMO
Status
Recruiting
Health condition type
Musculoskeletal and connective tissue disorders congenital
Study type
Interventional

ID

NL-OMON31250

Source

ToetsingOnline

Brief title

BSSO versus DOG for advancement of the mandible

Condition

  • Musculoskeletal and connective tissue disorders congenital
  • Bone and joint therapeutic procedures

Synonym

hypoplastic mandible

Research involving

Human

Sponsors and support

Primary sponsor :
Isala klinieken Zwolle, locatie Weezenlanden
Source(s) of monetary or material Support :
eigen middelen

Intervention

Keyword :
complication, distraction osteogenesis, mandible, osteotomy

Outcome measures

Primary outcome

Sensory disturbances in the lower lip.

Secondary outcome

Stability

Complications

Costs

Background summary

There are two surgical procedures for a mandibular advancement. The (dis)
advantages of these procedures in comparison with each other are not clear.

Study objective

To evaluate the two procedures for lengthening of the mandible.

Study design

Randomized clinical trial.

Intervention

BSSO or DOG

Study burden and risks

No extra controle visits or X-rays. A few questionnaires and sensory tests will
be done.

Public
Isala klinieken Zwolle, locatie Weezenlanden

Groot Wezenland 20
8011 JW Zwolle
Nederland
Scientific
Isala klinieken Zwolle, locatie Weezenlanden

Groot Wezenland 20
8011 JW Zwolle
Nederland

Listed location countries

Netherlands

Age

Adolescents (12-15 years)
Adolescents (16-17 years)
Adults (18-64 years)
Elderly (65 years and older)

Inclusion criteria

hypoplastic mandible

Exclusion criteria

advancement of more than 12 mm

Design

Study type :
Interventional
Masking :
Open (masking not used)
Control :
Uncontrolled
Primary purpose :
Treatment

Recruitment

NL
Recruitment status
:
Recruiting
Start date (anticipated) :
Enrollment :
90
Type :
Actual

Approved WMO
Date :
Application type :
First submission
Review commission :
METC Isala Klinieken (Zwolle)

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 NL18755.075.07