Jaw defect (or insufficient bone mass)
Conditions
Interventions
Group A:Implant placement 6 months after alveolar ridge preservation surgery
Group B:Implant placement 9 months after alveolar ridge preservation surgery
Group C:Implant placement 12 months after alveolar ridge preservation surgery
Sponsors
Hospital of Stomatology Wuhan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) Age range 18 - 70 years old (inclusive), gender is not limited; 2) Patients have teeth that need to be extracted and require implant restoration; 3) Periodontal health (periodontal probing depth < 4 mm), alveolar ridge preservation at the same time as tooth extraction; 4) There is a defect in the extraction socket, and the vertical bone defect height is <=5 mm; 5) After the tooth is extracted, there are at least three bone walls remaining in the extraction socket, and at least 1 adjacent tooth exists; 6) Patients with good oral environment and good compliance. 7) Patients voluntarily participate and sign the "Informed Consent Form".
Exclusion criteria
Exclusion criteria: 1) Patients with serious diseases of important organs such as heart, liver, lung, kidney, or serious diseases of blood, immune, or endocrine system; 2) Patients with poorly controlled diabetes (fasting blood sugar is still >= 8.0 mmol/L after drug control) and poorly controlled hypertension (systolic blood pressure >= 160 mmHg and/or diastolic blood pressure >= 100 mmHg); 3) Patients with bone metabolic diseases (such as osteoporosis, osteitis deformans, etc.), or who have taken nonsteroidal anti-inflammatory drugs, corticosteroids, tetracycline, bisphosphonates, or other drugs that affect bone regeneration 3 months before enrollment; 4) Patients with a history of head and neck radiotherapy; 5) Patients with untreated periodontitis, acute apical periodontitis, periapical abscess, and/or advanced periodontal disease need to be excluded; 6) Patients with poor oral environment who cannot maintain good oral hygiene care; 7) Patients who have received treatment with another similar product at the same implant site in the past; 8) Patients who smoke heavily (> 10 sticks/day); 9) Alcoholics or chronic drug abusers; 10) Pregnant or lactating women and those who plan to get pregnant within 6 months; 11) Allergic constitution, collagen allergy or other severe allergic reactions; 12) People with mental illness or mental disorders; 13) Patients who have participated in or are participating in other drug or device clinical trials in the past 3 months; 14) Other patients who are determined by the researchers to be ineligible for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| New bone formation rate;Residual graft material;The proportion of blood vessels and connective tissue;Bone volume fraction;Bone mineral density;Trabecular thickness;Trabecular number;Changes in buccal and palatal bone width at the implant site;Changes in buccal and palatal bone width at the bone augmentation site;Labial bone plate thickness; | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety evaluation-record the occurrence of postoperative complications and adverse events; | — |
Countries
China
Contacts
Public ContactYufeng Zhang
Hospital of Stomatology Wuhan university
Outcome results
None listed