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Completed

NCT Number: NCT03464786

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Peking University Stomatological Hospital

Beijing, Beijing Municipality, 100038, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lando® absorbable collagen membrane

Device

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

Geistlich Bio-Gide resorbable bilayer membrane

Device

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

Primary outcomes

  1. Change value of the width of alveolar ridge

    Time frame: 26 weeks

    Change value of the width of alveolar ridge by CT

Sponsors and collaborators

Lead sponsor

Shenzhen Lando Biomaterials Co., Ltd.

Industry

Collaborators

  • Peking University

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 14, 2018
Registry last updated
Sep 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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