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

Phase 4

Recruiting

• Conditions: K07.2; Anomalies of dental arch relationship

• Registration Number: DRKS00027229
• Lead Sponsor: niversitätsklinikum der RWTH Aachen

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-11-09
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

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

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.

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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. <br><br>Comparison using questionnaires preoperatively and postoperatively (general questionnaire and Orthognathic Quality of Life Questionnaire (OQLQ)) <br>Analysis of pre- and postoperative standard X-ray images

Secondary Outcome Measures

Name	Time	Method
Completion of treatment and surgical follow-up