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

Tooth Extraction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03464786
• Other study ID #: LD-M-201701
• Status: Completed
• Phase: N/A
• Start date: April 3, 2018
• Est. completion date: September 5, 2020

Study information

• Verified date: September 2020
• Source: Shenzhen Lando Biomaterials Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 119
• Est. completion date: September 5, 2020
• Est. primary completion date: September 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Tooth Extraction

Intervention

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

Locations

Country	Name	City	State
China	Peking University Stomatological Hospital	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Shenzhen Lando Biomaterials Co., Ltd.	Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change value of the width of alveolar ridge	Change value of the width of alveolar ridge by CT	26 weeks