A Clinical Study on the Efficacy and Safety of Lando® Absorbable Collagen Membrane in Oral Bone Repair

Study Overview
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Brief Summary
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This is a randomized, paralleled, control trial to validate the effectiveness and safety of Lando® absorbable collagen membrane for oral bone repair.

Official Title
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A Clinical Study on the Efficacy and Safety of Lando® Absorbable Collagen Membrane in Oral Bone Repair

Conditions
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Tooth Extraction

Intervention / Treatment
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* Device: Lando® absorbable collagen membrane
* Device: Geistlich Bio-Gide resorbable bilayer membrane


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: absorbable collagen membrane<br>Subjects randomized in this arm will receive Lando® absorbable collagen membrane after tooth extraction. | Device: Lando® absorbable collagen membrane<br>* Subjects who are fit for the study will be randomized to either intervention arms.<br>|
| Active Comparator: Bio-Gide resorbable bilayer membrane<br>Subjects randomized in this arm will receive Bio-Gide resorbable bilayer membrane after tooth extraction. | Device: Geistlich Bio-Gide resorbable bilayer membrane<br>* Subjects who are fit for the study will be randomized to either intervention arms.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change value of the width of alveolar ridge | Change value of the width of alveolar ridge by CT | 26 weeks |