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A prospective, multicenter, randomized, controlled, non-inferiority clinical trial of the safety and efficacy of absorbable collagen membranes for alveolar bone defect repair

A prospective, multicenter, randomized, controlled, non-inferiority clinical trial of the safety and efficacy of absorbable collagen membranes for alveolar bone defect repair

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100055027
Enrollment
Unknown
Registered
2021-12-30
Start date
2021-09-17
Completion date
Unknown
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

alveolar bone defects

Interventions

Experimental group:Use absorbable collagen membranes
Control group:Using oral absorbable biofilms

Sponsors

Peking University Third Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-65 years, gender is not limited; 2. A single tooth (at least one adjacent tooth) needs to be extracted; 3. No bone wall defect or unilateral bone wall defect after tooth extraction; 4. Those who volunteered to participate in this clinical trial and signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Those who can cause artifacts in oral imaging detection (such as metal dentures, porcelain teeth, etc.); 2. Patients with alveolar bone defects caused by aggressive and malignant bone tumors; 3. Buccal bone plate fenestration; 4. The height of the buccal bone defect exceeds 2/3 of the root length; 5. Patients with alveolar process fracture after tooth extraction; 6. Those with local inflammation, including untreated periodontal disease; 7. There is untreated acute apical periodontitis in the test teeth and adjacent teeth; 8. Poorly controlled diabetic patients (fasting blood glucose is still >=8.0 mmol/L after drug control); 9. Patients with insufficiency or abnormal liver and kidney function (ALT, AST > 1.5 times the upper limit of normal value, creatinine exceeds the upper limit of normal value and the investigator judges it to be clinically significant); 10. Patients with a history of local radiotherapy on the head or neck in the past 3 months; 11. Those with bleeding tendency or coagulation disorders; 12. Those who have received or are receiving drug therapy that may affect or promote bone metabolism in the past 3 months, including calcitonin, parathyroid hormone, bisphosphonates, steroid hormones, immunosuppressants and other drugs that researchers believe may affect bone metabolism; 13. Drug, alcohol, drug abuse or self-reported smoking/tobacco equivalents/chewing tobacco >10 cigarettes per day; 14. Physical or mental impairments affecting oral hygiene care; 15. Those who are known to be allergic to bovine sources or xenogeneic proteins; 16. Those with uncontrolled systemic diseases who cannot perform bone graft surgery; 17. Pregnant/lactating patients or patients who have a pregnancy plan within six months; 18. Patients who have participated in or are participating in clinical trials of other drugs/devices within 3 months; 19. The investigator believes that other patients are not suitable to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
the height change value of alveolar ridge;

Countries

China

Contacts

Public ContactWang Xiao
bysywangxiao@163.com+86 18511154321

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026