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NOT YET RECRUITING
NCT06536660
NA

Biodegradable Magnesium Bone Plate and Screw Fixation in Jaw Surgery

Sponsor: The University of Hong Kong

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy and safety of using high-purity magnesium bone plates and screws for internal fixation in jaw surgery. The investigators aim to assess whether these biodegradable magnesium devices promote normal bone healing and functional recovery while ensuring the safety of patients undergoing dentoalveolar surgery, fracture fixation, orthognathic surgery, or craniofacial reconstruction. The hypotheses are: 1. High-purity magnesium bone plates and screws are effective in bone fixation, promoting normal bone healing and functional recovery in jaw surgery. 2. High-purity magnesium bone plates and screws are safe in jaw surgery in terms of local side effects and systemic safety. Participants will undergo jaw surgery based on the clinical indications. High-purity magnesium bone plates and screws will be used for internal fixation during the surgical procedure. Participants will be followed up at 1 week, 3 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years after surgery to assess wound healing, functional recovery, and any side effects. If any side effects occur or deemed necessary, participants may be followed up for a longer period. During postoperative follow-up visits, X-ray or CBCT/CT imaging will be conducted routinely or when clinically indicated.

Official title: Development and Application of Biodegradable Magnesium Bone Plate and Screw Fixation in Jaw Surgery

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

62

Start Date

2024-08-15

Completion Date

2028-08-15

Last Updated

2024-08-05

Healthy Volunteers

No

Interventions

PROCEDURE

Magnesium bone plate and screw fixation in jaw surgery

Participants will undergo jaw surgery based on their clinical indications. High-purity magnesium bone plates and screws will be used for internal fixation during the surgical procedure.