Post-Extraction Sockets Healing
Conditions
Brief summary
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.
Interventions
BIOLOGICALPlasma Rich in Growth Factors PRGF-Endoret
PROCEDUREConventional closure of the lesion
Sponsors
Fundación Eduardo Anitua
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* subjects of both genders and ≥ 18 years old * Indication of a simple one molar extraction in the mandible. * Possibility of observation during the follow-up period.
Exclusion criteria
* Unerupted third molars or with horizontal inclination. * Severe swelling prior to surgery in the areas designated for extraction. * Suffering an alteration or a serious hematologic disease. * Be currently undergoing or have received radiotherapy, chemotherapy or immunosuppressive therapy, corticosteroids and/or anticoagulants 30 days prior to inclusion * In regular treatment with NSAIDs or other anti-inflammatory drugs. * History of chronic hepatitis or cirrhosis. * Diabetes mellitus with poor metabolic control (glycosylated hemoglobin \>9%) * Patients undergoing dialysis. * Presence of malignant tumors, hemangiomas or angiomas in the extraction area. * History of ischemic heart disease in the last year. * Pregnancy or planned pregnancy during the study follow-up period. * Metabolic Bone Disease. * Patients taking bisphosphonates both orally and intravenously. * In general, any inability to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of regenerated post-extraction sockets | 10-12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Inflammation | 3, 7 and 15 days post-extraction | Using a specific 0 to 3 Inflammation Score |
| Adverse events or complications | 10-12 weeks | — |
| Regenerated bone volume | 10-12 weeks | 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. |
| Post-operative pain (VAS) | 3, 7 and 15 days post-extraction | — |
| Soft Tissue Healing Index | 3, 7 and 15 days post-extraction | — |
Countries
Spain
Outcome results
None listed