Tenting Screws in Combination With Platelet Concentrate for Vertical Alveolar Ridge Augmentation

Study Overview
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Brief Summary
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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
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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.

Official Title
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Tenting Screws in Combination With Platelet Concentrate for Vertical Alveolar Ridge Augmentation: Prospective, Blinded, Randomized Controlled Trial

Conditions
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Bone Loss, Alveolar

Intervention / Treatment
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* Procedure: guided bone gereration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control group<br>Vertical alveolar bone augmentation was performed by GBR technique before implantation. BIO-OSS+ BIO-GIDE barrier membrane | Procedure: guided bone gereration<br>* 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.<br>* Other names: tenting screws, A-PRF, I-PRF;|
| Experimental: Treatment group 1<br>Vertical alveolar bone augmentation was performed by GBR technique and tenting screws before implantation. BIO-OSS+ BIO-GIDE barrier membrane+ tenting screws | Procedure: guided bone gereration<br>* 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.<br>* Other names: tenting screws, A-PRF, I-PRF;|
| Experimental: Treatment group 2<br>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 | Procedure: guided bone gereration<br>* 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.<br>* Other names: tenting screws, A-PRF, I-PRF;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | T0(before surgery), T2(6 months after GBR) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tenting screws, advanced platelet rich fibrin, injectable platelet rich fibrin, guided bone regeneration