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.

Overview

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.

Full Title of Study: “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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2023

Interventions

  • Procedure: Exodontia
    • Atraumatic exodontia followed by simple suture
  • Drug: Alveolar ridge preservation with a PRP (PRGF-Endoret)
    • Filling of the alveolus with PRGF clot and fibrin plug.
  • Device: Preparation of PRGF using Endoret technology
    • Preparation of PRGF using Endoret technology following manufacturer instructions

Arms, Groups and Cohorts

  • Active Comparator: Simple suture
  • Experimental: PRGF-Endoret

Clinical Trial Outcome Measures

Primary Measures

  • Bone regeneration
    • Time Frame: 12 months
    • Quantity of new bone measured in bone biopsies obtained after alveolar ridge preservation

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fundación Eduardo Anitua
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Mikel Allende, PhD, MBA, 945 16 06 53, mikel.allende@bti-implant.es

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