Healthy human volunteers who are planning to undergo orthognathic surgery at Oral and Maxillofacial Surgery clinic, Faculty of Dentistry, Chiang Mai University. Orthognathic surgery Prediabetes Bone metabolic markers Bone mineral density
Conditions
Interventions
Group of patients with normal fasting plasma glucose and HbA1C levels.,Group of patients with impaired fasting plasma glucose (100 - 125 mg/dL) and impaired HbA1C levels (5.7% - 6.4%.).
Screening,Screening
Control group,Prediabetes group
Sponsors
Faculty of Dentistry, Chiang Mai University
Eligibility
Sex/Gender
All
Age
20 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Non-growing patients (20-45 years old) 2. Planned for bimaxillary orthognathic surgery for skeletal discrepancies, malocclusion, or maxillofacial deformities. 3. No prior history of diabetes mellitus (Type 1 or Type 2). 4. Willingness to participate in the study, with signed informed consent. 5. Available for post-operative follow-up assessments over the study duration.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of Type 1 or Type 2 diabetes mellitus (T2DM) at the time of screening. 2. Use of antidiabetic medication (e.g., metformin, insulin, GLP1 receptor agonists) within the past 6 months. 3. History of metabolic bone diseases (e.g., osteoporosis, osteomalacia, Paget's disease, osteogenesis imperfecta). 4. Chronic use of medications affecting bone metabolism, such as Bisphosphonates or denosumab, Glucocorticoids (more than 5 mg prednisone equivalent for more than 3 months) , Hormone replacement therapy (HRT) 5. History of radiation therapy to the maxillofacial region. 6. Severe systemic conditions (e.g., chronic kidney disease, liver disease, autoimmune disorders) that could interfere with bone metabolism. 7. Presence of periodontitis (probing pocket depth of more than 5 mm in different quadrants, having a minimum of six permanent teeth in each quadrant) 8. Pregnancy or lactation at the time of surgery. 9. Currently receiving any kind of herbs and supplements 10. Active infections, malignancies, or systemic inflammatory diseases that may alter bone remodeling. 11. Previous orthognathic surgery or maxillofacial trauma affecting bone healing outcomes. 12. Inability to comply with post operative follow up visits or medical evaluations. 13. Le Fort I set back osteotomies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quantification of bone metabolic markers in blood serum 1) at preoperative period 2) at immediate post operative 3) at one-week after surgery 4) at one-month after surgery 5) at three-month after surgery 6) at six-month after surgery commercial enzyme-linked immunosorbent assay (ELISA) kits,Bone mineral density 1) at preoperative period 2) at immediate post operative 3) a at three-month after surgery 4) at six-month after surgery cone beam computed tomography (CBCT) radiographic analysis (NewTom GiANO HR (Newtom, Italy)) radiographic analysis | — |
Secondary
| Measure | Time frame |
|---|---|
| The correlation between fasting plasma glucose ,HbA1C levels and bone metabolic markers in blood serum 1) at preoperative period 2) at immediate post operative 3) at one-week after surgery 4) at one-month after surgery 5) at three-month after surgery 6) at six-month after surgery ICTP: MBS040005 MyBioSource/Sclerostin: MBS736604 MyBioSource/BALP: SB-E09033h, CUSABIO/osteocalcin: E-EL-H1343 Elabscience/P1NP: MBS455932 MyBioSource/plasma glucose: Medisafe fit Terumo,The correlation between fasting plasma glucose ,HbA1C levels and bone mineral density 1) at preoperative period 2) at immediate post operative 3) a at three-month after surgery 4) at six-month after surgery Pearson correlation coefficient | — |
Countries
Thailand
Contacts
Public ContactNapatsorn Imerb
Faculty of Dentistry, Chiang Mai University
Outcome results
None listed