Tooth Extraction
Conditions
Brief summary
This is a randomized, paralleled, control trial to validate the effectiveness and safety of Lando® absorbable collagen membrane for oral bone repair.
Interventions
DEVICELando® absorbable collagen membrane
Subjects who are fit for the study will be randomized to either intervention arms.
DEVICEGeistlich Bio-Gide resorbable bilayer membrane
Subjects who are fit for the study will be randomized to either intervention arms.
Sponsors
Peking University
Shenzhen Lando Biomaterials Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change value of the width of alveolar ridge | 26 weeks | Change value of the width of alveolar ridge by CT |
Countries
China
Outcome results
None listed