Status:
COMPLETED
A Clinical Study on the Efficacy and Safety of Lando® Absorbable Collagen Membrane in Oral Bone Repair
Lead Sponsor:
Shenzhen Lando Biomaterials Co., Ltd.
Collaborating Sponsors:
Peking University
Conditions:
Tooth Extraction
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This is a randomized, paralleled, control trial to validate the effectiveness and safety of Lando® absorbable collagen membrane for oral bone repair.
Eligibility Criteria
Inclusion
- 18\~65 years old;
- Subjects, whose single teeth (adjacent teeth intact) of incisor, canine or premolar is removed and bone graft is needed for alveolar ridge preservation, and need a delayed implant repair in more than 26 weeks.
- voluntary participation and sign on the informed consent form
Exclusion
- Participated in other clinical trials in 90 days before joined in the trial
- Having received in 90 days before joined in the trial and / or will receive the head and neck radiation therapy or chemist during the study
- Having received in 90 days before joined in the trial and / or will receive any drug treatment that may affect bone metabolism;
- patients with heart disease;
- patients with abnormal liver and kidney function;
- poor diabetes control;
- low or abnormal immunity, anaphylaxis and the researchers judged to be of clinical significance;
- HIV infected patients;
- bleeding tendency or coagulation disorders and researchers judged to be of clinical significance;
- mental disorder;
- women who are pregnant or breast-feeding or preparing for pregnancy in the next 26 weeks;
- severe smokers;
- patients with periodontitis without basic periodontal treatment;
- the fracture of alveolar process after tooth extraction;
- The loss of bone wall on any side of alveolar fossa was more than 2/3.
- other cases that researchers believe not suitable for the participants of the trial
Key Trial Info
Start Date :
April 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 5 2020
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT03464786
Start Date
April 3 2018
End Date
September 5 2020
Last Update
September 11 2020
Active Locations (1)
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1
Peking University Stomatological Hospital
Beijing, Beijing Municipality, China, 100038