Alveolar bone defect
Conditions
Interventions
Intervention group:3D-printed titanium mesh + resorbable collagen membrane
Control group:3D-printed titanium mesh
Sponsors
Tianjin Stomatological Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 65 years, no gender restriction; 2. Diagnosed with dentition defects via oral examination and imaging (CBCT), with alveolar bone defects at the edentulous site, classified as type 2/4, 3/4, or 4/4 according to the Terheyden bone defect classification, requiring the use of 3D-printed titanium mesh for bone augmentation; 3. At least one healthy adjacent tooth at the edentulous site; 4. Good compliance, able to complete preoperative examinations, surgery, and 6-month postoperative follow-up (including timely reexamination, acceptance of intraoral examination, and imaging assessment); 5. Not having participated in any other medical device or drug clinical trial within the past 3 months; 6. Generally good systemic health, without severe heart, liver, kidney, or other organ diseases, no coagulation disorders, diabetes mellitus (fasting blood glucose < 7.0 mmol/L), or osteoporosis; 7. Voluntarily participate in this trial and sign a written informed consent form.
Exclusion criteria
Exclusion criteria: 1. Refusal to participate in the trial or to sign the written informed consent form; 2. Presence of contraindications for bone graft surgery (e.g., severe coagulation disorders, acute phase of systemic infectious diseases); 3. Current smoking habit (>10 cigarettes/day); 4. Current intravenous use of bisphosphonates (e.g., sodium bisphosphonate), or a history of bisphosphonate-related osteonecrosis of the jaw within the past 3 years; 5. Significant mental disorders or psychological disturbances (e.g., severe anxiety disorder), or a history of drug or alcohol abuse (monthly alcohol consumption =1000 mL within the past year), or long-term use of sedative-hypnotic medications; 6. Inability to maintain good oral hygiene (e.g., due to hand motor impairment); 7. Ongoing oral or systemic infections (e.g., pneumonia, acute exacerbation of gingivitis), exposure to radiation (e.g., head and neck radiotherapy), cancer treatment (e.g., chemotherapy), or a history of oral radiation therapy within the past 6 months; 8. Presence of oral mucosal lesions in the surgical area (e.g., leukoplakia, lichen planus), xerostomia, generalized periodontitis (periodontal probing depth >5 mm, clinical attachment loss >3 mm), or pathological jawbone changes (e.g., jaw cyst, osteosarcoma); 9. Women who are currently pregnant, breastfeeding, or planning to become pregnant during the trial period (within 6 months after surgery); 10. Religious beliefs that explicitly reject products of animal origin (e.g., bovine or porcine collagen); 11. Inability to communicate effectively with the investigator (e.g., due to language barriers) or to comply with all trial requirements (e.g., inability to attend follow-up visits on time); 12. Other conditions deemed by the investigator as unsuitable for participation in the study (e.g., concomitant autoimmune diseases, long-term use of glucocorticoids).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Healing Period Complications;Two-Dimensional Evaluation of Horizontal and Vertical Bone Augmentation;Bone Augmentation Volume; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pain VAS Score;Histological Evaluation;Pseudo-membrane Thickness; | — |
Countries
China
Contacts
Public ContactWang Qingfu
Tianjin Stomatological Hospital
Outcome results
None listed