Bone Loss, AlveolarNCT04835532
Tenting Screws in Combination With Platelet Concentrate for Vertical Alveolar Ridge Augmentation
A study testing guided bone gereration in people with Bone Loss, Alveolar, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Alveolar bone resorption often occurs after tooth extraction. At present, guided bone regeneration technique is widely used in clinic since it leads to less trauma and less complications. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Loss, Alveolar
- What is being tested?
- guided bone gereration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteChina
- Study dates
- 10 Aug 2021to 1 Mar 2024
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18-80 years old;
- single tooth in the maxillary posterior area cannot be retained (third degree loosening / alveolar bone resorption to the periapical area), implantation is needed after extraction, and CBCT shows vertical bone defect ≥ 3mm;
- 4 weeks after extraction or missing teeth within 3-5 weeks;
- adjacent teeth exist and loosening is less than Ⅰ degree;
- periodontal disease in inactive stage, whole mouth bleeding index (FMBS) is less than 20%;
- thick gingival biological type.
- CBCT shows that the bone of the edentulous site meets the requirements of tent screw implantation (bone height ≥ 3mm and bone mineral density is sufficient);
- the patients and their families have informed consent and signed the informed consent form.
Who cannot join
- pregnant and lactating women;
- smoking (> 10 cigarettes per day) and alcoholism;
- taking anticoagulants within 3 months before operation;
- suffering from autoimmune diseases, diabetes, liver disease, blood system diseases and infectious diseases;
- patients taking any drugs that affect platelet function or whose platelet count is less than 200000/mm3 3 months before blood collection;
- patients who have been treated with bisphosphate / steroids for a long time;
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- have received alveolar ridge bone augmentation surgery;
- previous history of radiotherapy in the head and neck;
- acute inflammation in edentulous sites;
- inability to maintain good oral hygiene or follow-up visits as required.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, 310000
陈 莉丽, Master, +86 13606507966, chenlili_1030@163.com
About this study
Official title: Tenting Screws in Combination With Platelet Concentrate for Vertical Alveolar Ridge Augmentation: Prospective, Blinded, Randomized Controlled Trial
Alveolar bone resorption often occurs after tooth extraction. At present, guided bone regeneration technique is widely used in clinic since it leads to less trauma and less complications. Tenting screw technology, basic on the classical GBR, implants screws into the surgical area to prevent the barrier membrane from collapsing. Moreover, advanced platelet rich fibrin and injectable platelet-rich fibrin are used to provide the osteogenic function. The investigators intend to increase vertical alveolar bone augmentation by combining tenting screws and A-PRF, I-PRF.
Read the detailed description
Alveolar bone resorption often occurs after tooth extraction. At present, guided bone regeneration technique is widely used in clinic since it leads to less trauma and less complications. Tenting screw technology, basic on the classical GBR, implants screws into the surgical area to prevent the barrier membrane from collapsing. Moreover, advanced platelet rich fibrin and injectable platelet-rich fibrin are used to provide the osteogenic function. The investigators intend to increase vertical alveolar bone augmentation by combining tenting screws and A-PRF, I-PRF.
- Conditions
- Bone Loss, Alveolar
- Being tested
- guided bone gereration
- Keywords
- tenting screws, advanced platelet rich fibrin, injectable platelet rich fibrin, guided bone regeneration
- 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.
guided bone gererationProcedure or surgery
Also called tenting screws, A-PRF, I-PRF
guided bone generation: GBR is a procedure that uses barrier membranes with or without particulate bone grafts or/and bone substitutes.
tenting screws: Screws are implanted in the surgical area to prevent the barrier membrane from collapsing.
A-PRF/I-PRF: Obtained by autologous blood centrifugation.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Experimental | Vertical alveolar bone augmentation was performed by GBR technique before implantation.
BIO-OSS+ BIO-GIDE barrier membrane Receives: Procedure: guided bone gereration |
| Treatment group 1 | Experimental | Vertical alveolar bone augmentation was performed by GBR technique and tenting screws before implantation.
BIO-OSS+ BIO-GIDE barrier membrane+ tenting screws Receives: Procedure: guided bone gereration |
| Treatment group 2 | Experimental | Vertical alveolar bone augmentation was performed by GBR technique in combination with tenting screws and A-PRF, I-PRF before implantation.
BIO-OSS+ BIO-GIDE barrier membrane+ tenting screws+A-PRF, I-PRF Receives: Procedure: guided bone gereration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Buccal bone augmentation, BBA(bone height changes between T0 and T2)
The sagittal plane of CBCT image is selected as the measuring plane, and the horizontal tangent of the inferior margin of maxillary sinus / paranasal sinus is selected as the baseline. The investigaters will measure the bone height changes by CBCT(three-dimensional CT) and Related measurement software. The unit of measurement is millimeter.
Measured: T0(before surgery), T2(6 months after GBR)
Secondary outcomes (1)
Lingual bone augmentation, LBA(bone height changes between T0 and T2)
The sagittal plane of CBCT image is selected as the measuring plane, and the horizontal tangent of the inferior margin of maxillary sinus / paranasal sinus is selected as the baseline.
The sagittal plane of CBCT image is selected as the measuring plane, and the horizontal tangent of the inferior margin of maxillary sinus / paranasal sinus is selected as the baseline.The investigaters will measure the bone height changes by CBCT(three-dimensional CT) and Related measurement software. The unit of measurement is millimeter.
Measured: T0(before surgery), T2(6 months after GBR)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2021
- Study start10 Aug 2021
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Loss, AlveolarStudies 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 69 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04835532
- Sponsor's protocol ID
- 2021-0050
- Status last verified
- Feb 2021
- First submitted
- 16 Mar 2021
- Last updated
- 29 Sep 2021
- 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 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tenting Screws in Combination With Platelet Concentrate for Vertical Alveolar Ridge Augmentation: Prospective, Blinded, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04835532
- Acronym / sponsor ID
- 2021-0050
- Conditions
- Bone Loss, Alveolar
- Keywords
- tenting screws, advanced platelet rich fibrin, injectable platelet rich fibrin, guided bone regeneration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 69 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 10 Aug 2021 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 8 Apr 2021 (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.
Alveolar bone resorption often occurs after tooth extraction. At present, guided bone regeneration technique is widely used in clinic since it leads to less trauma and less complications. Tenting screw technology, basic on the classical GBR, implants screws into the surgical area to prevent the barrier membrane from collapsing. Moreover, advanced platelet rich fibrin and injectable platelet-rich fibrin are used to provide the osteogenic function. The investigators intend to increase vertical alveolar bone augmentation by combining tenting screws and A-PRF, I-PRF.
Detailed description
Alveolar bone resorption often occurs after tooth extraction. At present, guided bone regeneration technique is widely used in clinic since it leads to less trauma and less complications. Tenting screw technology, basic on the classical GBR, implants screws into the surgical area to prevent the barrier membrane from collapsing. Moreover, advanced platelet rich fibrin and injectable platelet-rich fibrin are used to provide the osteogenic function. The investigators intend to increase vertical alveolar bone augmentation by combining tenting screws and A-PRF, I-PRF.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Experimental | Procedure: guided bone gererationVertical alveolar bone augmentation was performed by GBR technique before implantation. BIO-OSS+ BIO-GIDE barrier membrane |
| Treatment group 1 | Experimental | Procedure: guided bone gererationVertical alveolar bone augmentation was performed by GBR technique and tenting screws before implantation. BIO-OSS+ BIO-GIDE barrier membrane+ tenting screws |
| Treatment group 2 | Experimental | Procedure: guided bone gererationVertical alveolar bone augmentation was performed by GBR technique in combination with tenting screws and A-PRF, I-PRF before implantation. BIO-OSS+ BIO-GIDE barrier membrane+ tenting screws+A-PRF, I-PRF |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18-80 years old;
- single tooth in the maxillary posterior area cannot be retained (third degree loosening / alveolar bone resorption to the periapical area), implantation is needed after extraction, and CBCT shows vertical bone defect ≥ 3mm;
- 4 weeks after extraction or missing teeth within 3-5 weeks;
- adjacent teeth exist and loosening is less than Ⅰ degree;
- periodontal disease in inactive stage, whole mouth bleeding index (FMBS) is less than 20%;
Key exclusion criteria (10 listed)
- pregnant and lactating women;
- smoking (> 10 cigarettes per day) and alcoholism;
- taking anticoagulants within 3 months before operation;
- suffering from autoimmune diseases, diabetes, liver disease, blood system diseases and infectious diseases;
- patients taking any drugs that affect platelet function or whose platelet count is less than 200000/mm3 3 months before blood collection;
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 |
|---|---|---|
| guided bone gererationAlso: tenting screws, A-PRF, I-PRFguided bone generation: GBR is a procedure that uses barrier membranes with or without particulate bone grafts or/and bone substitutes. tenting screws: Screws are implanted in the surgical area to prevent the barrier membrane from collapsing. A-PRF/I-PRF: Obtained by autologous blood centrifugation. | Procedure or surgery | Control group, Treatment group 1, Treatment group 2 |
Primary outcome
Buccal bone augmentation, BBA(bone height changes between T0 and T2)
Time frame: T0(before surgery), T2(6 months after GBR)
The sagittal plane of CBCT image is selected as the measuring plane, and the horizontal tangent of the inferior margin of maxillary sinus / paranasal sinus is selected as the baseline. The investigaters will measure the bone height changes by CBCT(three-dimensional CT) and Related measurement software. The unit of measurement is millimeter.
1 secondary outcome
Lingual bone augmentation, LBA(bone height changes between T0 and T2)
Time frame: T0(before surgery), T2(6 months after GBR)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing guided bone gereration in people with Bone Loss, Alveolar, 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 10 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 29 Sep 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact 陈 莉丽, Master (+86 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?
Buccal bone augmentation, BBA(bone height changes between T0 and T2) (time frame: T0(before surgery), T2(6 months after GBR)). 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 29 Sep 2021.