Alveolar Bone LossEarly Phase 1NCT05743452
Clinical Trial on the Safety and Efficacy of Magnesium Doped Calcium Silicate 3d Alveolar Bone Repair Unit for Periodontal Bone Defects
A Early Phase 1 study testing GBR with CS@Mg in people with Alveolar Bone Loss, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
The goal of this clinical trial is to test in height increment of alveolar bone and safety evaluation index. The main question it aims to answer are: The safety and effectiveness of magnesium calcium silicate three-dimensional alveolar bone repair unit in the repair of periodontal bone defects Participants will be… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Alveolar Bone Loss
- What is being tested?
- GBR with CS@Mg
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteChina
- Study dates
- 18 Aug 2022to Dec 2023
- Phase
- Early Phase 1
- 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
- Age 18-65 years old, healthy;
- Good oral hygiene, do not smoke;
- There is bone defect at the tooth extraction site, and it is planned to carry out implant repair after tooth extraction;
- There is at least one healthy adjacent tooth in the mesial and distal surface of the tooth extraction site;
- The residual height from the bottom of the extraction socket to the crest of the alveolar ridge is ≥ 3 mm, with at least one bone wall;
- Can understand the purpose of the trial
- Be willing to cooperate with surgical treatment and follow-up, voluntarily participate in the trial
- Sign the informed consent form.
Who cannot join
- The affected tooth is in the acute inflammatory stage;
- Those who have bad habits such as smoking and drinking；
- Subjects who cause artifacts in oral imaging examination, such as the extraction site and its adjacent teeth are metal Dentures, porcelain teeth;
- Patients are allergic to ceramic implants;
- Those who have participated in other clinical trials in the past 3 months;
- The investigator estimated that the compliance was poor, or there were other factors that were not suitable for the test;
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- Patients with a history of diabetes or abnormal blood glucose detection (fasting blood glucose ≥ 7mmol/L);
- Abnormal liver and kidney function (AST, ALT, creatinine ≥ 1.5 times ULN);
- Patients with serious endocrine and metabolic diseases;
- Have a history of tertiary hypertension;
- Have a history of osteoporosis;
- Those who are not suitable for surgery due to the history of malignant tumor or other serious diseases;
- People with a history of autoimmune diseases;
- Pregnant or lactating women;
- Mental disorders without autonomous behavior ability;
- Patients who are using steroids that interfere with calcium metabolism within 3 months before the signing of informed consent
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Oral Medicine, the Second Affiliated Hospital School of Medicine of Zhejiang University
Hangzhou
Lili Chen, Prof., 13606507966, chenlili_1030@163.com
About this study
The goal of this clinical trial is to test in height increment of alveolar bone and safety evaluation index.
The main question it aims to answer are:
- The safety and effectiveness of magnesium calcium silicate three-dimensional alveolar bone repair unit in the repair of periodontal bone defects Participants will be treated through Guided Bone Regeneration operation with calcium magnesium silicate three-dimensional alveolar bone repair unit.
- Conditions
- Alveolar Bone Loss
- Being tested
- GBR with CS@Mg
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GBR with CS@MgDevice
The patient was treated by GBR with magnesium calcium silicate scaffold for alveolar bone defect.
| Study group | Role | What they receive |
|---|---|---|
| CS@Mg | Experimental | The patient was treated by GBR with magnesium calcium silicate scaffold for alveolar bone defect. Receives: Device: GBR with CS@Mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal bone width
The width of buccal lingual alveolar ridge was measured 1 mm below the crest of alveolar ridge.
Measured: 24 weeks after operation
Evaluation of wound healing
The wound healing evaluation scale was modified according to the indicators described by Lobene et al (1986) and will be used to evaluate the wound healing after surgery. The gingival tissue in the material implantation area was evaluated.
Measured: 2 weeks after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2023
- Study start18 Aug 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alveolar Bone LossStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Device: GBR with CS@Mg The patient was treated by GBR with magnesium calcium silicate scaffold for alveolar bone defect.
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05743452
- Sponsor's protocol ID
- 2022-0535
- Status last verified
- Feb 2023
- First submitted
- 5 Feb 2023
- Last updated
- 24 Feb 2023
- 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 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial on the Safety and Efficacy of Magnesium Doped Calcium Silicate 3d Alveolar Bone Repair Unit for Periodontal Bone Defects
- ClinicalTrials.gov ID
- NCT05743452
- Acronym / sponsor ID
- 2022-0535
- Conditions
- Alveolar Bone Loss
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 18 Aug 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 24 Feb 2023 (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.
The goal of this clinical trial is to test in height increment of alveolar bone and safety evaluation index.
The main question it aims to answer are:
- The safety and effectiveness of magnesium calcium silicate three-dimensional alveolar bone repair unit in the repair of periodontal bone defects Participants will be treated through Guided Bone Regeneration operation with calcium magnesium silicate three-dimensional alveolar bone repair unit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Device: GBR with CS@Mg The patient was treated by GBR with magnesium calcium silicate scaffold for alveolar bone defect.
| Arm | Type | Receives |
|---|---|---|
| CS@Mg | Experimental | Device: GBR with CS@MgThe patient was treated by GBR with magnesium calcium silicate scaffold for alveolar bone defect. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 18-65 years old, healthy;
- Good oral hygiene, do not smoke;
- There is bone defect at the tooth extraction site, and it is planned to carry out implant repair after tooth extraction;
- There is at least one healthy adjacent tooth in the mesial and distal surface of the tooth extraction site;
- The residual height from the bottom of the extraction socket to the crest of the alveolar ridge is ≥ 3 mm, with at least one bone wall;
Key exclusion criteria (16 listed)
- The affected tooth is in the acute inflammatory stage;
- Those who have bad habits such as smoking and drinking；
- Subjects who cause artifacts in oral imaging examination, such as the extraction site and its adjacent teeth are metal Dentures, porcelain teeth;
- Patients are allergic to ceramic implants;
- Those who have participated in other clinical trials in the past 3 months;
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 |
|---|---|---|
| GBR with CS@MgThe patient was treated by GBR with magnesium calcium silicate scaffold for alveolar bone defect. | Device | CS@Mg |
Primary outcome
Horizontal bone width
Time frame: 24 weeks after operation
The width of buccal lingual alveolar ridge was measured 1 mm below the crest of alveolar ridge.
Evaluation of wound healing
Time frame: 2 weeks after operation
The wound healing evaluation scale was modified according to the indicators described by Lobene et al (1986) and will be used to evaluate the wound healing after surgery. The gingival tissue in the material implantation area was evaluated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- Individual participant dataSharing planned: No
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Effect of Ascorbic Acid-Loaded I-PRF With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation
Alveolar Ridge Preservation Post-Extraction Bone Healing Dental Implant Site Development Tooth Loss, Alveolar Bone Regeneration Following Odontectomy
Not yet recruitingObservational study
Diagnostic Accuracy of Large Language Models for Peri-Implant Marginal Bone Loss on Panoramic Radiographs
Peri-implantitis, Alveolar Bone Loss
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Two Bovine Xenografts in Lateral Window Sinus Augmentation With or Without Bone Marrow Blood
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing GBR with CS@Mg in people with Alveolar Bone Loss, run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 8 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: status not confirmed, as of the sponsor's last update on 24 Feb 2023. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lili Chen, Prof. (13606507966, chenlili_1030@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Horizontal bone width (time frame: 24 weeks after operation). The study lists 2 primary outcomes in all. 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 24 Feb 2023.