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A multicentre, randomized, single-blind, positive controlled, non-inferiority clinical trail to evaluate the efficacy and safety of Bioresorbable membrane in Guided Bone Regeneration

A multicentre, randomized, single-blind, positive controlled, non-inferiority clinical trail to evaluate the efficacy and safety of Bioresorbable membrane in Guided Bone Regeneration

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030212
Enrollment
Unknown
Registered
2020-02-25
Start date
2020-03-02
Completion date
Unknown
Last updated
2020-03-02

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

Conditions

Oral bone defect

Interventions

experimental group:Bioresorbable membrane
control group:Bioresorbable Matrix Barrier (GUIDOR)

Sponsors

Stomatological Hospital affiliated to Sun Yat-Sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. 18-65 years old, no gender limitation; 2. Patients with oral bone defect need to treat through guided bone regeneration; 3. Patients and/or guardians agree to take part in the trial and sign the Informed Consent Form(ICF).

Exclusion criteria

Exclusion criteria: 2. Residual 4 bone walls at the tooth extraction fossa site; 2. The adjacent teeth in the edentulous area have been using metal porcelain crown or metal cast pile; 3. Operation area with acute or chronic infection; 4. Participating in other similar or intervention clinical trials within 30 days before signing the ICF; 5. Have a history of allergic to geltin, or server allergic disease, or server immunodeficiency disease; 6. Uncontrolled mMetabolic disorders, likewise diabetes mellitus; 7. Medical conditions requiring prolonged use of steroids; 8. Alcoholism or drug abuse, smokers of more than 10 cigarettes per day before taking part in the trail; 9. Pregnant and lactating females; 10. Poor compliance; 11. Other circumstances not suitable for the trial judged by investigators.

Design outcomes

Primary

MeasureTime frame
Rate of efficacy of bone regeneration;

Secondary

MeasureTime frame
Soft tissue index;

Countries

China

Contacts

Public ContactDeng Feilong

Stomatological Hospital affiliated to Sun Yat-Sen University

drdfl@163.com+86 20-83862537

Outcome results

None listed

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