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Completed

NCT Number: NCT04093583

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Eduardo Anitua Private Clinic, Vitoria-Gasteiz, Alava, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exodontia

Procedure

Atraumatic exodontia followed by simple suture

Alveolar ridge preservation with a PRP (PRGF-Endoret)

Drug

Filling of the alveolus with PRGF clot and fibrin plug.

Preparation of PRGF using Endoret technology

Device

Preparation of PRGF using Endoret technology following manufacturer instructions

Primary outcomes

  1. Bone regeneration

    Time frame: 12 months

    Quantity of new bone measured in bone biopsies obtained after alveolar ridge preservation

Sponsors and collaborators

Lead sponsor

Fundación Eduardo Anitua

Other

Registry information

Important dates

Study start
2019
Primary completion
2025
Study completion
2025
First posted
Sep 18, 2019
Registry last updated
Feb 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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