Clincosm LogoSign in Get a demo

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

Sponsor
Shenzhen Lando Biomaterials Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03464786
Collaborator
Peking University (Other)
119
Enrollment
1
Location
2
Arms
29.1
Actual Duration (Months)
4.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Lando® absorbable collagen membrane
  • Device: Geistlich Bio-Gide resorbable bilayer membrane
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
119 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Clinical Study on the Efficacy and Safety of Lando® Absorbable Collagen Membrane in Oral Bone Repair
Actual Study Start Date :
Apr 3, 2018
Actual Primary Completion Date :
Sep 5, 2020
Actual Study Completion Date :
Sep 5, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: absorbable collagen membrane

Subjects randomized in this arm will receive Lando® absorbable collagen membrane after tooth extraction.

Device: Lando® absorbable collagen membrane
Subjects who are fit for the study will be randomized to either intervention arms.
Active Comparator: Bio-Gide resorbable bilayer membrane

Subjects randomized in this arm will receive Bio-Gide resorbable bilayer membrane after tooth extraction.

Device: Geistlich Bio-Gide resorbable bilayer membrane
Subjects who are fit for the study will be randomized to either intervention arms.

Outcome Measures

Primary Outcome Measures

  1. Change value of the width of alveolar ridge [26 weeks]

    Change value of the width of alveolar ridge by CT

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking University Stomatological Hospital Beijing Beijing China 100038

Sponsors and Collaborators

  • Shenzhen Lando Biomaterials Co., Ltd.
  • Peking University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shenzhen Lando Biomaterials Co., Ltd.
ClinicalTrials.gov Identifier:
NCT03464786
Other Study ID Numbers:
  • LD-M-201701
First Posted:
Mar 14, 2018
Last Update Posted:
Sep 11, 2020
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 11, 2020