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

NCT03464786 | Completed

• 1 other identifier: LD-M-201701
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tooth Extraction

Outcome Measures

Primary Outcomes (1)

• Change value of the width of alveolar ridge

  Change value of the width of alveolar ridge by CT

  26 weeks

Study Arms (2)

absorbable collagen membrane

EXPERIMENTAL

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

Device: Lando® absorbable collagen membrane

Bio-Gide resorbable bilayer membrane

ACTIVE COMPARATOR

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

Device: Geistlich Bio-Gide resorbable bilayer membrane

Interventions

Lando® absorbable collagen membrane DEVICE

Subjects who are fit for the study will be randomized to either intervention arms.

absorbable collagen membrane

Geistlich Bio-Gide resorbable bilayer membrane DEVICE

Subjects who are fit for the study will be randomized to either intervention arms.

Bio-Gide resorbable bilayer membrane

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \~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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenzhen Lando Biomaterials Co., Ltd.: lead
• Peking University: collaborator

Study Sites (1)

Peking University Stomatological Hospital

Beijing, Beijing Municipality, 100038, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: March 14, 2018
• Study Start: April 3, 2018
• Primary Completion: September 5, 2020
• Study Completion: September 5, 2020
• Last Updated: September 11, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)