Tooth ExtractionNCT03464786
A Clinical Study on the Efficacy and Safety of Lando® Absorbable Collagen Membrane in Oral Bone Repair
A study testing Lando® absorbable collagen membrane and Geistlich Bio-Gide resorbable bilayer membrane in people with Tooth Extraction, run by Shenzhen Lando Biomaterials Co., Ltd. at 1 site in China.
Trial summary
This is a randomized, paralleled, control trial to validate the effectiveness and safety of Lando® absorbable collagen membrane for oral bone repair. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Tooth Extraction
- What is being tested?
- Lando® absorbable collagen membrane and Geistlich Bio-Gide resorbable bilayer membrane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteChina
- Study dates
- 3 Apr 2018to 5 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Stomatological Hospital
Beijing, Beijing Municipality, 100038
About this study
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
- Being tested
- Lando® absorbable collagen membrane, Geistlich Bio-Gide resorbable bilayer membrane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lando® absorbable collagen membraneDevice
Subjects who are fit for the study will be randomized to either intervention arms.
Geistlich Bio-Gide resorbable bilayer membraneDevice
Subjects who are fit for the study will be randomized to either intervention arms.
| Study group | Role | What they receive |
|---|---|---|
| absorbable collagen membrane | Experimental | Subjects randomized in this arm will receive Lando® absorbable collagen membrane after tooth extraction. Receives: 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. Receives: Device: Geistlich Bio-Gide resorbable bilayer membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change value of the width of alveolar ridge
Change value of the width of alveolar ridge by CT
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2018
- Study start3 Apr 2018
- Primary completion5 Sep 2020
- Study completion5 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth ExtractionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenzhen Lando Biomaterials Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03464786
- Sponsor's protocol ID
- LD-M-201701
- Status last verified
- Sep 2020
- First submitted
- 7 Mar 2018
- Last updated
- 11 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study on the Efficacy and Safety of Lando® Absorbable Collagen Membrane in Oral Bone Repair
- ClinicalTrials.gov ID
- NCT03464786
- Acronym / sponsor ID
- LD-M-201701
- Conditions
- Tooth Extraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- Shenzhen Lando Biomaterials Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Peking University
- Study start
- 3 Apr 2018 (actual)
- Primary completion
- 5 Sep 2020 (actual)
- Study completion
- 5 Sep 2020 (actual)
- First posted
- 14 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, paralleled, control trial to validate the effectiveness and safety of Lando® absorbable collagen membrane for oral bone repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| absorbable collagen membrane | Experimental | Device: Lando® absorbable collagen membraneSubjects randomized in this arm will receive Lando® absorbable collagen membrane after tooth extraction. |
| Bio-Gide resorbable bilayer membrane | Active comparator | Device: Geistlich Bio-Gide resorbable bilayer membraneSubjects randomized in this arm will receive Bio-Gide resorbable bilayer membrane after tooth extraction. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lando® absorbable collagen membraneSubjects who are fit for the study will be randomized to either intervention arms. | Device | absorbable collagen membrane |
| Geistlich Bio-Gide resorbable bilayer membraneSubjects who are fit for the study will be randomized to either intervention arms. | Device | Bio-Gide resorbable bilayer membrane |
Primary outcome
Change value of the width of alveolar ridge
Time frame: 26 weeks
Change value of the width of alveolar ridge by CT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lando® absorbable collagen membrane and Geistlich Bio-Gide resorbable bilayer membrane in people with Tooth Extraction, run by Shenzhen Lando Biomaterials Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change value of the width of alveolar ridge (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2020.