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.

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Implantation
• Intervention / Treatment: Procedure: Exodontia; Drug: Alveolar ridge preservation with a PRP (PRGF-Endoret); Device: Preparation of PRGF using Endoret technology

• Study Type: Interventional
• Enrollment (Anticipated): 46
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Mikel Allende, PhD, MBA; Phone Number: 257 945 16 06 53; Email: mikel.allende@bti-implant.es

Study Locations

• Spain
  • A Coruña, Spain, 15005
    • Recruiting
    • Clínica Dental González Mosquera
    • Contact: Antonio González Mosquera, DDS
  • Alava
    • Vitoria-Gasteiz, Alava, Spain, 01005
      • Recruiting
      • Eduardo Anitua Private Clinic
      • Contact: Eduardo Anitua, MD,PhD
      • Sub-Investigator: Alia Murias, DDS
  • Bizkaia
    • Getxo, Bizkaia, Spain, 48930
      • Recruiting
      • Clinica dental Murias
      • Contact: Alia Murias
      • Principal Investigator: Alia Murias
  • Viscay
    • Galdakao, Viscay, Spain, 48960
      • Recruiting
      • Clinica Dental Loroño
      • Contact: Joseba Loroño, DDS
      • Principal Investigator: Joseba Loroño, DDS
      • Sub-Investigator: Markel Loroño, DDS
    • Getxo, Viscay, Spain, 48991
      • Not yet recruiting
      • Clinica Ereaga
      • Sub-Investigator: Alia Murias, DDS
      • Contact: Alia Murias, DDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Simple suture	Procedure: Exodontia; Atraumatic exodontia followed by simple suture
EXPERIMENTAL: PRGF-Endoret	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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fundación Eduardo Anitua

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 7, 2019
• Primary Completion (ANTICIPATED): December 31, 2023
• Study Completion (ANTICIPATED): December 31, 2023

Study Registration Dates

• First Submitted: September 16, 2019
• First Submitted That Met QC Criteria: September 16, 2019
• First Posted (ACTUAL): September 18, 2019

Study Record Updates

• Last Update Posted (ACTUAL): May 9, 2022
• Last Update Submitted That Met QC Criteria: May 6, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: PRGF; alveolar ridge preservation; exodontia
• Other Study ID Numbers: FIBEA_04_EC_19_ALV; 2019-001167-75 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No