Tenting Screws in Combination With Platelet Concentrate for Vertical Alveolar Ridge Augmentation
1 other identifier
interventional
69
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2021
CompletedFirst Posted
Study publicly available on registry
April 8, 2021
CompletedStudy Start
First participant enrolled
August 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2024
CompletedSeptember 29, 2021
February 1, 2021
1.1 years
March 16, 2021
September 27, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
T0(before surgery), T2(6 months after GBR)
Secondary Outcomes (1)
Lingual bone augmentation, LBA(bone height changes between T0 and T2)
T0(before surgery), T2(6 months after GBR)
Other Outcomes (1)
Bone density, BD
T2(6 months after GBR)
Study Arms (3)
Control group
EXPERIMENTALVertical alveolar bone augmentation was performed by GBR technique before implantation. BIO-OSS+ BIO-GIDE barrier membrane
Treatment group 1
EXPERIMENTALVertical alveolar bone augmentation was performed by GBR technique and tenting screws before implantation. BIO-OSS+ BIO-GIDE barrier membrane+ tenting screws
Treatment group 2
EXPERIMENTALVertical 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
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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;
- 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.
You may not qualify if:
- 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;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Hangzhou, Zhejiang, 310000, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2021
First Posted
April 8, 2021
Study Start
August 10, 2021
Primary Completion
October 1, 2022
Study Completion
March 1, 2024
Last Updated
September 29, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share