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The persistent and chronic apical periodontitis has caused great difficulties for clinical physicians. Ensuring rapid and successful healing of the extensively damaged periapical region is a pressing issue that needs to be addressed. The treatment options include traditional apical surgery, simultaneous placement of bone powder and membrane after apical surgery, and simultaneous placement of sticky bone (bone powder mixed with concentrated growth factors gel) and membrane. However, high-quality evidence regarding these various treatment options is scarce. The purpose of this study is to compare the advantages and disadvantages of each treatment option, in order to guide clinical physicians in the application of apical surgery.
This prospective study will recruit 72 patients with chronic periapical periodontitis in their anterior teeth or premolars, all of which have received comprehensive root canal treatment. The patients will be randomly divided into four groups: Group A, which will undergo only apical surgery (including apicoectomy, inflammation debridement, and retrofilling of the root apex); Group B, which will undergo apical surgery plus bone powder; Group C, which will undergo apical surgery plus CGF (concentrated growth factors); and Group D, which will undergo apical surgery plus bone powder and CGF gel. Each group will consist of 18 patients, and all surgeries will be performed by the same experienced doctor. The participants will receive a 1-year follow-up with the assistance of a professional doctor, including questionnaire data and daily records of pain and swelling at 2, 6, and 12 hours and 7 days after the intervention. Cone-beam computed tomography (CBCT) images will also be taken before the surgery, immediately after the surgery, and at 2, 3, 4, 6, and 12 months post-surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| only apical surgery group | No Intervention | which will undergo only apical surgery (including apicoectomy, inflammation debridement, and retrofilling of the root apex) | |
| bone substitute group | Experimental | which will undergo apical surgery plus bone substitute |
|
| concentrated growth factors group | Experimental | which will undergo apical surgery plus CGF (concentrated growth factors) |
|
| bone substitute and CGF group | Experimental | which will undergo apical surgery plus bone substitute and CGF gel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| concentrated growth factor | Other | Implanting concentrated growth factor into the area of root apical bone defect |
|
| Measure | Description | Time Frame |
|---|---|---|
| Root apex healing status | Measurements of postoperative apical bone healing were obtained using cone-beam computed tomography (CBCT) in horizontal, coronal, and sagittal planes, respectively. Unit: mm | up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| pain status | Record the pain condition of patients postoperatively at 2, 6, and 12 hours, as well as daily for 7 days after the surgery through questionnaire surveys. The pain scale is as follows: 0: No pain;
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wen Luo | Contact | 15103660395 | luowen228@163.com | |
| Kaiyue Zheng | Contact | 18976528173 | 1032638813@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Hainan Medical University | Recruiting | Haikou | Hainan | 570102 | China |
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| ID | Term |
|---|---|
| D018786 | Bone Substitutes |
| ID | Term |
|---|---|
| D001672 | Biocompatible Materials |
| D001697 | Biomedical and Dental Materials |
| D008420 | Manufactured Materials |
| D013676 | Technology, Industry, and Agriculture |
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| bone substitute | Other | Implanting bone substitute into the area of root apical bone defect |
|
| concentrated growth factor + bone substitute | Combination Product | Implanting concentrated growth factor + bone substitute into the area of root apical bone defect |
|
| 7 days |
| postoperative swelling | Record the postoperative swelling of patients postoperatively at 2, 6, and 12 hours, as well as daily for 7 days after the surgery through questionnaire surveys. Postoperative swelling score will be rated on the following scale: 0: No swelling;
| 7 days |