Skip to content

A Multi-center, Randomized, Blinding and Parallel-controlled Non-inferiority Clinical trial: The Safety and Validity to Absorbable Collagen Membrane applied in Guided Bone Regeneration Surgery in Stomatology Department

A Multi-center, Randomized, Blind, Parallel-controlled Non-inferiority Clinical trial: The Safety and Validity to Absorbable Collagen Membrane applied in Guided Bone Regeneration Surgery in Stomatology Department

Status
Active, not recruiting
Phases
Phase 3
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900022157
Enrollment
Unknown
Registered
2019-03-27
Start date
2017-09-15
Completion date
Unknown
Last updated
2019-04-01

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

Conditions

his product can be used for the repair and treatment of periodontal or alveolar bone soft and hard tissues, acts as a physical barrier, or works with bone repair materials to guide the regeneration of

Interventions

Experimental group:Implanted membrane
Control group:Implanted Genoss's membrane

Sponsors

Beijing Chao-yang Hospital of Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Voluntary participation and signing of informed consent; 2. There are indications for dental implants and insufficient bone mass, and GBR technique is needed for bone increment; 3. There is at least one adjacent tooth; 4. Aged 18 to 65 years old male and female; 5. Single patient treatment during this clinical study; 6. Can cooperate with this test plan and receive regular visits after surgery.

Exclusion criteria

Exclusion criteria: 1. Subjects that do not meet the need for bone-incremental surgery alone; 2. Subjects with severe systemic disease (researcher's decision); 3. Those who are allergic to collagen (inquiry about medical history); 4. Hypertensive and diabetic subjects whose condition cannot be stably controlled (researcher's judgment); 5. A subject with a history of head and neck radiotherapy; 6. Subjects with a history of bone diseases such as osteoporosis and bone tumors (inquiry history); 7. Long-term use of non-steroidal anti-inflammatory drugs, bisphosphonates, corticosteroids, tetracyclines, immunosuppressants and other drugs that affect bone metabolism or bone healing; 8. Pregnant or lactating women, as well as male and female subjects scheduled to conceive during the trial; 9. Subjects with significant ectopic and torsional teeth and adjacent teeth; 10. a subject with a apical lesion in the bone graft or adjacent teeth; 11. Subjects with acute infection in the bone graft area; 12. Subjects whose blood routine, blood biochemistry (except creatinine) is less than 50% of the lower limit of the reference value or 50% above the upper limit of the reference value; 13. Subjects that other investigators believe cannot be selected.

Design outcomes

Primary

MeasureTime frame
Incremental changes in alveolar bone width;

Secondary

MeasureTime frame
Incremental changes in alveolar bone width;Bone density assessment;New bone contour evaluation;Wound soft tissue healing evaluation;

Countries

China

Contacts

Public ContactWang Zuomin

Beijing Chao-yang Hospital of Capital Medical University

wzuomin@sina.com+86 13801263071

Outcome results

None listed

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