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

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

Study Overview

• Status: Completed
• Conditions: Tooth Extraction
• Intervention / Treatment: Device: Lando® absorbable collagen membrane; Device: Geistlich Bio-Gide resorbable bilayer membrane

• Study Type: Interventional
• Enrollment (Actual): 119
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100038
      • Peking University Stomatological Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Shenzhen Lando Biomaterials Co., Ltd.
• Collaborators: Peking University

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2018
• Primary Completion (Actual): September 5, 2020
• Study Completion (Actual): September 5, 2020

Study Registration Dates

• First Submitted: March 7, 2018
• First Submitted That Met QC Criteria: March 7, 2018
• First Posted (Actual): March 14, 2018

Study Record Updates

• Last Update Posted (Actual): September 11, 2020
• Last Update Submitted That Met QC Criteria: September 9, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: LD-M-201701

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No