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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-001167-75 | EudraCT Number |
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Immediately following tooth removal, a healing process begins that affects the eventual alveolar bone volume and architecture of the alveolar ridge. Satisfactory and timely healing are essential to obtain ideal functional reconstruction. Traumatic removal of a tooth, or a poor healing response, may lead to excessive bone loss delaying tooth replacement, requiring expensive and time-consuming reconstructive surgeries, or even the inability to be corrected. The Plasma Rich in Growth Factors (PRGF-Endoret) has shown its therapeutic potential effect to minimize the consequences of this aggression, promoting the regeneration of both hard and soft involved tissues.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRGF-Endoret | Experimental |
| |
| Conventional treatment | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plasma Rich in Growth Factors PRGF-Endoret | Biological |
| ||
| Conventional closure of the lesion |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of regenerated post-extraction sockets | 10-12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Regenerated bone volume | Measurement of the regenerated bone volume at final follow-up in relation to the initial post-extraction socket total volume measured by CT-Scanner and expressed as a percentage. | 10-12 weeks |
| Post-operative pain (VAS) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eduardo Anitua, MD, DDS, PhD | Clinica Dental Eduardo Anitua | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ClĂnica Dental Eduardo Anitua | Vitoria-Gasteiz | Spain |
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| Procedure |
|
| 3, 7 and 15 days post-extraction |
| Soft Tissue Healing Index | 3, 7 and 15 days post-extraction |
| Inflammation | Using a specific 0 to 3 Inflammation Score | 3, 7 and 15 days post-extraction |
| Adverse events or complications | 10-12 weeks |