Randomized Clinical Trial, Conventional Treatment-controlled, Studying the Efficacy of Plasma Rich in Growth Factor (PRGF®) in Alveolar Ridge Preservation After Simple Exodontia in the Anterior Region of Maxilla.

Study Overview
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Brief Summary
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This RCT aims to study the efficacy and safety of PRGF-Endoret in alveolar ridge preservation in the aesthetic zone. 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, Conventional Treatment-controlled, Studying the Efficacy of Plasma Rich in Growth Factor (PRGF®) in Alveolar Ridge Preservation After Simple Exodontia in the Anterior Region of Maxilla.

Conditions
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Dental Implantation

Intervention / Treatment
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* Procedure: Exodontia
* Drug: Alveolar ridge preservation with a PRP (PRGF-Endoret)
* Device: Preparation of PRGF using Endoret technology


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Subjects of both sexes with an age greater than or equal to 18 years. Clinical indication for a simple exodontia in the aesthetic zone (from left 2nd premolar to the right 2nd premolar in the maxilla). Need of a dental implant placement in the extraction site. Availability to follow-up during the treatment period Subjects with non-active periodontal disease. Buccal dehiscence < than 25% in the vestibular table Exclusion Criteria: - Presence of an active infection Loss of any plate of the socket Severe inflammation in the area of the exodontia previous to the intervention Have previous diagnosis of a coagulopathy. Have previous diagnosis of any autoinmune disease. Have received radiotherapy, chemotherapy or immunosuppressive treatments, systemic corticosteroids and/or anticoagulants the 30 days prior to inclusion Regular treatment with AINES or other antiinflammatory drugs Previous history of chronic hepatitis or heatic cirrhosis Positive markers for VHC, AgHBs, VIH I/II or Treponema pallidum Uncontrolled diabetes mellitus (Glycosylated hemoglobin higher than 9%) Subjects submitted to hemodyalisis Presence of malignant tumour, haemangiomas or angioma in the exodontia region. Previous history of ischemic cardiopathy in the last year. Pregnancy or womens in childbearing age who do not take contraception measures. Nursing womens Metabolic bone disease Ongoing treatment with biphosphonates both through oral or intravenous administration Smoking habits (> 10 cigarrettes/day) In general, any disability 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> | Procedure: Exodontia<br>* Atraumatic exodontia followed by simple suture<br>|
| Experimental: PRGF-Endoret<br> | Procedure: Exodontia<br>* Atraumatic exodontia followed by simple suture<br>Drug: Alveolar ridge preservation with a PRP (PRGF-Endoret)<br>* Filling of the alveolus with PRGF clot and fibrin plug.<br>Device: Preparation of PRGF using Endoret technology<br>* Preparation of PRGF using Endoret technology following manufacturer instructions<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 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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exodontia, PRGF, alveolar ridge preservation