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A prospective multicenter randomized blind parallel positive controlled clinical trial on the evaluation of biological mesh for alveolar ridge preservation

A prospective multicenter randomized blind parallel positive controlled clinical trial on the evaluation of biological mesh for alveolar ridge preservation

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100044716
Enrollment
Unknown
Registered
2021-03-26
Start date
2020-11-01
Completion date
Unknown
Last updated
2021-10-26

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

Conditions

Alveolar bone defect after tooth extraction operation

Interventions

biological mesh produced by Beijing Ruijian Biotechnology Co., Ltd:biological mesh produced by Beijing Ruijian Biotechnology Co., Ltd
Geistlich Bio-Gid:Geistlich Bio-Gid

Sponsors

Beijing Chaoyang Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Aged 18-70 years, gender unlimited; 2) Subjects requiring alveolar ridge preservation immediately after tooth extraction; 3) There are four bony walls in the tooth extraction fossa and at least one adjacent tooth; 4) During the study period, the subjects participated in the trial with single tooth; 5) Subjects are willing to participate in the test, and the subjects or their legal agent can sign in the ICF.

Exclusion criteria

Exclusion criteria: 1) Severe insufficiency of heart, liver and kidney; 2) Poor control of diabetes and hypertension; 3) Long-term use of non-steroidal anti-inflammatory drugs, bisphosphonates, corticosteroids, tetracycline, immunosuppressants and other drugs that affect bone metabolism or bone healing; 4) People with known history of allergy and specific allergy to pig-derived materials; 5) Subjects who refuse to use pig-derived medical products due to religious or ethnic reasons; 6) Participated in any clinical trials of drugs and/or medical devices within 3 months prior to the study; 7) Other circumstances in which the investigator considers the subject unsuitable for participation in this study.

Design outcomes

Primary

MeasureTime frame
Alveolar bone width change;

Secondary

MeasureTime frame
Alveolar bone height change;The curative effect of soft tissue healing;Bone density and new bone profile evaluation;

Countries

China

Contacts

Public ContactZuomin Wang

Beijing Chaoyang Hospital, Capital Medical University

wzuomin@sina.com+86 13801263071

Outcome results

None listed

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