Plasma Rich in Growth Factors in the Preservation of the Alveolar Ridge After Simple Molar Tooth Extractions.

Study Overview
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Brief Summary
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This Randomized Clinical Trial aims to study the efficacy and safety of PRGF-Endoret in alveolar ridge preservation after single molar extractions. The control group is the spontaneous healing occuring after the suturing of the alveolus. The primary endpoint is the bone regeneration measured in biopsies obtained from the regenerated alveolar bone.

Official Title
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Randomized Clinical Trial, Controlled by Conventional Treatment, of Plasma Rich in Growth Factors (PRGF®) in the Preservation of the Alveolar Ridge After Simple Molar Tooth Extractions.

Conditions
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Dental Implantation

Intervention / Treatment
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* Drug: Alveolar ridge preservation with a PRP (PRGF-Endoret)
* Drug: Blood clot and simple suture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age> 18 years Clinical indication for simple tooth extraction in the posterior sectors (from the second premolar to upper and lower second molars) Need to place a dental implant in the same position of the extraction Availability of observation during the period of treatment Signature of the informed consent Exclusion Criteria: Third molars Active periodontal disease Simultaneous extraction of two adjacent pieces in the same quadrant Oral dehiscence ≥ 25% Alveolus depth <7mm Loss of some wall of the alveolus Severe inflammation in the extraction area Previous diagnosis of coagulopathies Previous diagnosis of autoimmune disease Be receiving, or have received the 30 days prior to extraction treatment with radiotherapy, chemotherapy, immunosuppressants, systemic corticosteroids or anticoagulants Regular treatment with NSAIDs History of chronic hepatitis or liver cirrhosis Positive markers for HCV, AfHBs, HIV-I / II or TP Diabetes mellitus with poor metabolic control (evidence of glycated hemoglobin> 9%) Dialysis treatment Presence of malignant tumors, hemangiomas or angioma in the extraction area. History of ischemic heart disease in the last year Pregnancy or women of childbearing age who do not take action contraceptives Lactating women Previous diagnosis of metabolic bone disease Antiresorptive treatment Treatment with monoclonal antibodies Smoker> 10 cigarettes / day Any inability to participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Simple suture<br>Atraumatic exodontia followed by simple suture | Drug: Blood clot and simple suture<br>* Filling the alveolus with blood clot<br>|
| Experimental: PRGF-Endoret<br>Atraumatic exodontia followed by simple suture | Drug: Alveolar ridge preservation with a PRP (PRGF-Endoret)<br>* Filling of the alveolus with PRGF clot and fibrin plug.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone regeneration | Quantity of new bone measured in bone biopsies obtained after alveolar ridge preservation | 12 weeks post-extraction | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Score (VAS) | Evolution of pain assessed by the visual analog scale (VAS). Values ranging 0 to 10 (0=no pain and 10=worst pain) | 3, 7 and 15 days post-extraction | 
| Inflammation score | Evolution of inflammation evaluated by ordinal scale from 0 to 3 (0=no inflammation; 3=severe inflammation) | 3, 7 and 15 days post-extraction | 
| Soft tissue healing index | Soft tissue healing index according to the scale of Laundry. Values ranging 1 to 5 (1=poor healing, 5=excellent healing) | 3, 7 and 15 days post-extraction | 
| Changes in the dimension of the alveolar ridge | Changes in the dimension of the alveolar ridge by means of superimposition of digital files of models of plaster after 12 weeks post-extraction | 12 weeks post-extraction | 
| Soft tissue histomorphometric changes | - Soft tissue histomorphometric changes after evaluated by soft tissue biopsy | 12 weeks post-extraction | 
| Change in the bone dimensions of the alveolar ridge | Change in the bone dimensions of the alveolar ridge evaluated by CBCT between the post-extraction day and the week 12 post-extraction. | 12 weeks post-extraction | 
| Change in bone density | Change in bone density (Hounsfield units) evaluated by the CBCT at three different points between the post-extraction week and 12 weeks. | 12 weeks post-extraction | 
| Vitamin D levels |  | 12 weeks post-extraction | 
| Frequency of surgical and postsurgical complications |  | 12 weeks post-extraction | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exodontia, PRGF, Alveolar Ridge preservation