Comparison of TriLock Bridging Plates with conventional Bridging plates in the context of complex mandibular reconstruction – a pilot study

Comparison of TriLock Bridging Plates with conventional Bridging plates in the context of complex mandibular reconstruction – a pilot study - TriLock Bridging plates for mandibular reconstruction

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00017312

Enrollment

Registered

2019-12-13

Start date

2019-12-16

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

C41.1 K10.2 S02.64 S02.65

Interventions

Group 1: MODUS 2.0 TriLock Bridging Plates Group 2: MODUS 2.5 Locking Reconstruction Plates

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Inclusion criteria

Inclusion criteria: - Male/female patients, requiring segmental mandibular reconstruction due to various inevitable medical reasons with the aid of mandibular reconstruction plates including: - Severe mandibular trauma - Osteonecrosis of the jaw - Malignant tumorous disease involving the resection of the mandible - Age range: 18-85y - Written consent of the participant after being informed

Exclusion criteria

Exclusion criteria: Non-compliant patients - Minors Medical causes - Contraindications according to the manufacturer’s IFU - NYHA IV - Severe mandibular trauma without segmental mandibular reconstruction - Mandibular tumour resection, without segmental mandibular resection. - Mandibular resection, due to osteonecrosis of the jaw, without segmental mandibular resection. - Limited anaesthesiologic fitness, which does not allow for elaborate reconstructive mandibular procedures. - Pregnancy Informed Consent - Patients, who meet the inclusion criteria, but do not wish to participate in the trial, cannot be enrolled to the study

Design outcomes

Primary

Measure	Time frame
The primary aim of the trial is to compare the performance and intraoperative usability of the two plate designs (APPLICABILTY). Comparison between MODUS 2.5 Locking mandibular reconstruction plates and the MODUS 2.0 TriLock Bridging plate system in terms of the intraoperative usabiltiy of the plating systems. Comparison between MODUS 2.5 Locking mandibular reconstruction plates and the MODUS 2.0 TriLock Bridging plate system in terms of the intraoperative adaptability of the plating systems.	—

Measure

Time frame

The primary aim of the trial is to compare the performance and intraoperative usability of the two plate designs (APPLICABILTY). Comparison between MODUS 2.5 Locking mandibular reconstruction plates and the MODUS 2.0 TriLock Bridging plate system in terms of the intraoperative usabiltiy of the plating systems. Comparison between MODUS 2.5 Locking mandibular reconstruction plates and the MODUS 2.0 TriLock Bridging plate system in terms of the intraoperative adaptability of the plating systems.

—

Secondary

Measure	Time frame
1. postoperative quality of life (SF-36) 1a. Preoperatively 1b. 6 months post op 1c. 12 months post op 2. Safety of the reconstruction plates	—

Countries

Austria

Contacts

Public ContactMichael Schwaiger

Department of Oral and maxillofacial surgery, Medical University of Graz

michael.schwaiger@medunigraz.at031638580722

Outcome results

None listed

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