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Biodegradable Magnesium Bone Plate and Screw Fixation in Jaw Surgery

NCT06536660 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 62

Last updated 2024-08-05

No results posted yet for this study

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.

Conditions

  • Orthognathic Surgical Procedures

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.

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Yiu Yan Leung · The University of Hong Kong

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-15
Primary Completion
2027-08-15
Completion
2028-08-15

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06536660 on ClinicalTrials.gov