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Distal bone loss of the second molar due to extraction of the third molar is one of the most common pathological conditions that results in tooth loss of second molar. However, regeneration of functional alveolar bone has proved difficult. Therefore, the investigators conduct a two-arm study to evaluate the efficacy and safety of alveolar bone regeneration induced by gelatin sponge-loaded apoptotic vesicle complex in patients with mandibular third molar extraction.
This study is a single-center, prospective, two-arm study to evaluate the efficacy and safety of alveolar bone regeneration induced by gelatin sponge-loaded apoptotic vesicle complex in patients with mandibular third molar extraction. This study plans to include 30 subjects from the Department of Stomatology of the Fifth Affiliated Hospital of Guangzhou Medical University. One socket for each participant in this study will receive gelatin sponge-loaded apoptotic vesicle complex after third molar extraction and socket debridement. The other side of socket for each participant in this study will receive commercial gelatin sponge after the same surgery. All participants will undergo screening and baseline visits. After surgery, the participants will be followed up for 1 year.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gelatin sponge-loaded apoptotic vesicle complex | Experimental | 4 * 10^10 apoptotic vesicles derived from umbilical cord mesenchymal stem cells were loaded in a gelatin sponge（Kuaikang®）. A piece of gelatin sponge-loaded apoptotic vesicle complex was placed in an extraction socket after tooth extraction. |
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| Gelatin sponge only | Active Comparator | A piece of gelatin sponge（Kuaikang®）was placed in an extraction socket after tooth extraction. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gelatin sponge-loaded apoptotic vesicle complex（Kuaikang®) | Drug | The experimental group |
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| Measure | Description | Time Frame |
|---|---|---|
| Bone volume fraction of regenerated bone tissue in the extraction area at 3 months after operation | CBCT is a cone-beam projection computerized reconstruction tomography device. Its principle is that the X-ray generator uses a low radiation dose to make a circular DR (digital projection) around the projection body. Then the data obtained in the "intersection" after digital projection around the projection body multiple times is "reconstructed" in the computer to obtain a three-dimensional image. CBCT can observe the three-dimensional level of bone regeneration, so as to calculate the bone volume fraction of the regenerated bone tissue. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Hemostatic time after third molar extraction | After the third molar was completely extracted, commercial gelatin sponge or gelatin sponge loaded with apoptotic vesicle complex were placed in the socket. The time to hemostasis in the extraction socket was observed and recorded at the same time. | 0 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Fifth Affiliated Hospital of Guangzhou Medical University | Guangzhou | Guangdong | 510055 | China |
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| Gelatin sponge only （Kuaikang®) | Drug | The positive control group |
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