Post-Extraction Sockets Healing Clinical Trial
Official title:
Randomized Clinical Trial, Controlled With Conventional Treatment, of Efficacy and Safety of Plasma Rich in Growth Factors (PRGF-Endoret) in the Regeneration of Post-extraction Sockets in Simple Extractions of Molars in the Mandible
| Verified date | August 2021 |
| Source | Fundación Eduardo Anitua |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 60 |
| Est. completion date | December 2012 |
| Est. primary completion date | December 2012 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Spain | Clínica Dental Eduardo Anitua | Vitoria |
| Lead Sponsor | Collaborator |
|---|---|
| Fundación Eduardo Anitua |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of regenerated post-extraction sockets | 10-12 weeks | ||
| Secondary | 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 | |
| Secondary | Post-operative pain (VAS) | 3, 7 and 15 days post-extraction | ||
| Secondary | Soft Tissue Healing Index | 3, 7 and 15 days post-extraction | ||
| Secondary | Inflammation | Using a specific 0 to 3 Inflammation Score | 3, 7 and 15 days post-extraction | |
| Secondary | Adverse events or complications | 10-12 weeks |