Biodegradable Magnesium Bone Plate and Screw Fixation in Jaw Surgery
NCT Number: NCT06536660
Acronym: MgJawSurgery
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Orthognathic Surgical Procedures
Interventions: PROCEDURE: Magnesium bone plate and screw fixation in jaw surgery
Sponsor: The University of Hong Kong
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 62
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-08-15
Completion Date: 2028-08-15

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.

Primary Outcome Measures: The efficacy of using high-purity magnesium bone plate and screw fixation in jaw surgery, Efficacy is defined as the rate of successful bone healing and intended functional recovery of the jaw after surgery. Efficacy will be evaluated by clinical assessment and radiological assessment in terms of normal bone healing and functional recovery. Patients will be followed up at 1 week, 3 weeks, 6 weeks, 3 months, 6 months, 1 year, and 2 years after surgery. The occlusal function will be evaluated by the occlusal alignment and the resumption of normal diet. The bone structure will be assessed using plain X-ray immediately after surgery, and at 3 months, 6 months, 1 year, and 2 years post-surgery. CBCT/CT will also be performed to evaluate bone healing and potential complications immediately after surgery (serving as baseline reference), and at 3 months and 1 year after surgery. If CBCT/CT is taken, then plain X-ray will be omitted. The postoperative X-ray schedules represent standard procedures at our center for patients undergoing internal fixation., 1 week - 2 years
Secondary Outcome Measures: Magnesium degradation, Magnesium degradation refers to the process of magnesium dissolving or corroding over time in body fluids, eliminating the need for additional surgeries to remove the implant. The degradation rate of magnesium will be monitored over time to ensure a close match with bone healing, providing sufficient support and fixation throughout the healing process. Additionally, the production and retention of hydrogen gas will be monitored during the degradation process, as excessive hydrogen gas accumulation could lead to temporary swelling or discomfort in surrounding tissues, which will be counted as local side effects if clinically symptomatic., 1 week - 2 years|Local side effects, Local side effects or complications, such as emphysema, infection, implant rejection, screw loosening, or delayed healing, will be closely monitored., 1 week - 2 years|Systemic side effects, Magnesium ions should be metabolized without causing detrimental effects on vital organs or overall health; however, a sudden release of magnesium ions could potentially result in hypermagnesemia, leading to cardiovascular complications or neurological disorders., 1 week - 2 years