Biodegradable Magnesium Bone Plate and Screw Fixation in Jaw Surgery

NCT06536660 | Not Yet Recruiting

• 1 other identifier: UW 24-175
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief 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. 1.High-purity magnesium bone plates and screws are effective in bone fixation, promoting normal bone healing and functional recovery in jaw surgery.
2. 2.High-purity magnesium bone plates and screws are safe in jaw surgery in terms of local side effects and systemic safety.

Conditions

Orthognathic Surgical Procedures

Keywords

Biodegradable Magnesium Bone Plate; Screw Fixation; Jaw Surgery; Orthognathic Surgical Procedures

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Magnesium degradation

  1 week - 2 years

• Local side effects

  1 week - 2 years

• Systemic side effects

  1 week - 2 years

Study Arms (1)

Magnesium bone plate and screw fixation in jaw surgery

EXPERIMENTAL

Procedure: Magnesium bone plate and screw fixation in jaw surgery

Interventions

Magnesium bone plate and screw fixation in jaw surgery PROCEDURE

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.

Magnesium bone plate and screw fixation in jaw surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must be 18 years of age or older.
• Participants must have confirmed indications for jaw surgery with internal fixation, such as alveolar onlay bone grafting, fracture fixation, orthognathic surgery, or reconstructive surgery.
• Participants should have adequate bone quality and sufficient bone volume to support the placement of magnesium bone plates and screws.
• Participants must provide written informed consent, indicating their understanding of the potential risks and benefits of magnesium bone plate and screw fixation.

You may not qualify if:

• Participants with certain medical conditions that may affect bone healing or increase the risk of complications, such as uncontrolled diabetes, severe osteoporosis, multiple myelomas, or active bone infections.
• Participants with medical conditions that may exacerbate or predispose them to systemic side effects of magnesium implants, thus contraindicating their use, should be excluded. These conditions include chronic kidney disease, hypermagnesemia, severe electrolyte imbalances, severe heart disease (especially in those with a history of arrhythmias or heart failure), myasthenia gravis, abnormal thyroid functions, hyperparathyroidism, and adrenocortical insufficiency.
• Participants with known allergies or hypersensitivity to magnesium.
• Participants with an ASA score of 3 or above, indicating a higher risk for general anesthesia.
• Participants who are pregnant or breastfeeding.
• Participants deemed unlikely to comply with the study protocol, such as attending follow-up appointments or adhering to post-operative care instructions.

Sponsors & Collaborators

• The University of Hong Kong: lead

MeSH Terms

Interventions

Orthognathic Surgical Procedures

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures; Surgical Procedures, Operative; Osteotomy; Orthopedic Procedures; Dentistry

Study Officials

• Yiu Yan Leung

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yiu Yan Leung

CONTACT

28590511; mikeyyleung@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor in Oral and Maxillofacial Surgery

Study Record Dates

• First Submitted: June 26, 2024
• First Posted: August 5, 2024
• Study Start: August 15, 2024
• Primary Completion (Estimated): August 15, 2027
• Study Completion (Estimated): August 15, 2028
• Last Updated: August 5, 2024

Record last verified: 2024-07