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Guided tissue regeneration(GTR) uses membranous materials to shield gingival epithelial cells and connective tissue cells which grow more rapidly, creating an effective closed space and time for periodontal ligament cells with regenerative potential, so that new cementum is formed on the root surface and periodontal ligament fibers are embedded, resulting in regenerative healing. In order to improve the effect of periodontal regeneration therapy, as early as 1990s, scholars began to mix platelet concentrate and bone graft in periodontal regenerative surgery to improve the ability of local bone induction and tissue healing. Studies have shown that platelet concentrate, which is rich in a variety of growth factors in autologous blood, can promote soft tissue and bone tissue healing by acting on tissue healing cells (osteoblasts, epithelial cells, connective tissue cells, etc.). It is closely related to periodontal regeneration; the regenerative component of platelet concentrate, growth factor, and the structure of fibrin network containing growth factor are the key to promote tissue repair and regeneration.Modified platelet-rich fibrin (advanced platelet rich fibrin,APRF) and concentrated growth factor (CGF) are the latest generation of platelet concentrates. A number of studies have shown that APRF and CGF contain more cytokines, have a denser fibrin network, and show stronger ability to promote the migration and proliferation of gingival fibroblasts, suggesting that both of them may have better ability to promote bone tissue healing. At present, the latest generation of platelet concentrate has been widely used in implant surgery, but their clinical effects in periodontal regeneration surgery are still lack of conclusive evidence. there is no report on comparing the clinical effects of the two through randomized clinical controlled trials.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GTR group | No Intervention | only conventional GTR technique was used to treat periodontal bone defect, | |
| APRF+GTR group | Active Comparator | GTR technique combined with APRF was used to treat periodontal bone defect |
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| CGF+GTR group | Active Comparator | GTR technique combined with CGF was used to treat periodontal bone defect |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| APRF | Other | 20ml venous blood was collected from the elbow before operation and centrifuged with a special centrifuge. One piece of APRF gel was chopped and mixed with Bio-oss, and the other piece was pressed into a thin film; the mixture of APRF and Bio-oss was filled into the bone defect, covered with a properly trimmed Bio-gide film, and then covered with APRF film |
| Measure | Description | Time Frame |
|---|---|---|
| CAL (clinical attachment level) | The distance from periodontal pocket bottom to CEJ was measured by periodontal probe (mm). Record six sites of each tooth (the mesial, median and distal site of the buccal and tongue surface ).In order to ensure the operability and scientificity of follow-up, it is defined as follows. | Baseline(V0)，Change from Baseline at 12 weeks (V1)，Change from Baseline at 24 weeks (V2)，Change from Baseline at 48 weeks (V3) |
| Measure | Description | Time Frame |
|---|---|---|
| PD（probe depth） | use a periodontal probe (UNC-15,Hu-Friedy,Chicago,IL) paralleling to the long axis of the tooth to measure the distance from the bottom of the periodontal pocket to the gingival margin (mm), record six sites of each tooth (the mesial, median and distal site of the buccal and tongue surface ). | Baseline(V0)，Change from Baseline at 12 weeks (V1)，Change from Baseline at 24 weeks (V2)，Change from Baseline at 48 weeks (V3) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lihong Lei, associate senior doctor | Contact | 13989463654 | zjullh@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lei Lihong | Recruiting | Hangzhou | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 19, 2020 | Jul 6, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 19, 2020 | Jul 6, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D055113 | Chronic Periodontitis |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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This study is a single-center, simple, randomized parallel group design clinical trial in which each random group is allocated according to the proportion of 1:1:1
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Researcher B is responsible for including the subjects and assigning the number of the subjects according to the order of treatment. During the operation, researcher B will give the sealed envelope to the surgeon L according to the number, then leave, and will not participate in surgery, measurement and other studies. Researcher C is responsible for measuring various indicators on a regular basis. Until the end of the experiment, C did not know the grouping of the subjects.
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| CGF | Other | 20ml venous blood was collected from the elbow before operation and centrifuged with a special centrifuge. One piece of CGF gel was chopped and mixed with Bio-oss, and the other piece was pressed into a thin film; the mixture of CGF and Bio-oss was filled into the bone defect, covered with a properly trimmed Bio-gide film, and then covered with CGF film |
|
| mobility | use a tweezer to clamp the incisal areas of the anterior teeth or the pit groove on the occlusal surface of the posterior teeth and shake the teeth faciolingually, mesiodistally and vertically I degree : abnormal mobility faciolingually or less than 1mm positioning II degree : abnormal mobility faciolingually and mesiodistally or loosening range of 1-2mm. III degree : abnormal mobility faciolingually, mesiodistally and vertically or loosening range is greater than 2mm. | Baseline(V0)，Change from Baseline at 12 weeks (V1)，Change from Baseline at 24 weeks (V2)，Change from Baseline at 48 weeks (V3) |
| BOP(bleeding of probe) | observe for 10-15 seconds after probe to see whether it bleeds.Record six sites of each tooth (the mesial, median and distal site of the buccal and tongue surface ). | Baseline(V0)，Change from Baseline at 12 weeks (V1)，Change from Baseline at 24 weeks (V2)，Change from Baseline at 48 weeks (V3) |
| RBL（adiographic bone level） | Locate the reference point at the deepest PD site of the affected tooth：cemento-enamel junction（CEJ），alveolar crest（AC），bone defect（BD）.RBL is the straight line distance from CEJ to BD (mm) | Baseline(V0)，Change from Baseline at 24 weeks (V2)，Change from Baseline at 48 weeks (V3) |
| IC | IC is the straight line distance from AC to BD (mm) | Baseline(V0)，Change from Baseline at 24 weeks (V2)，Change from Baseline at 48 weeks (V3) |
| regenerated bone volume parameters | in mimics software, threshold was set according to the gray value of the affected tooth and its surrounding alveolar bone, image editing and region growth were used to form a mask of the three-dimensional reconstruction area. The three-dimensional calculation function was used to reconstruct the three-dimensional shape of the alveolar bone in the target area. Furthermore, the structure of alveolar bone was optimized by remeshing and smooth. The volume of alveolar bone before and after operation was calculated by Boolean operation to obtain the model of regenerated alveolar bone and its volume was measured. | Baseline(V0)，Change from Baseline at 24 weeks (V2)，Change from Baseline at 48 weeks (V3) |
| Defect fill (%) | Defect fill (%) = (preoperative IC- and postoperative IC) / preoperative IC × 100% | Baseline(V0)，Change from Baseline at 24 weeks (V2)，Change from Baseline at 48 weeks (V3) |
| Defect resolution (%) | Defect resolution (%) = (preoperative RBL- and postoperative RBL) / preoperative RBL × 100% | Baseline(V0)，Change from Baseline at 24 weeks (V2)，Change from Baseline at 48 weeks (V3) |
| D002908 |
| Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |