Evaluation of the accuracy of bimaxillary osteotomies with patient-specific implants and conventional planning - a randomized study

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00027229

Enrollment

100

Registered

2022-11-09

Start date

2022-11-17

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

K07.2

Interventions

Group 1: conventional planning without the use of patient specific implants Group 2: virtual planning with patient specific implants

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients with an indication for a bimaxillary osteotomy should be included in the study after completion of the orthodontic pretreatment.

Exclusion criteria

Exclusion criteria: Inoperable patients as well as patients with previous operations in the head and neck area or severe mental disorders should not be included in the study project. Patients with signs of COVID-19 infection, respiratory symptoms and fever are not allowed to participate in the study.

Design outcomes

Primary

Measure	Time frame
Inclusion of a total of 100 patients, of which 50 patients are planned conventionally randomly and 50 patients are planned digitally with the insertion of patient-specific implants. Comparison using questionnaires preoperatively and postoperatively (general questionnaire and Orthognathic Quality of Life Questionnaire (OQLQ)) Analysis of pre- and postoperative standard X-ray images	—

Secondary

Measure	Time frame
Completion of treatment and surgical follow-up	—

Countries

Germany

Contacts

Public ContactAli Modabber

Mund-, Kiefer und Gesichtschirurgie Uniklinikum Aachen

mkg-chirurgie@ukaachen.de02418038470

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026