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Completed

NCT Number: NCT04945629

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

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.

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Key information

Conditions

DENTAL IMPLANTATION

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinica Eduardo Anitua

Vitoria-Gasteiz, Spain

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Alveolar ridge preservation with a PRP (PRGF-Endoret)

Drug

Filling of the alveolus with PRGF clot and fibrin plug.

Blood clot and simple suture

Drug

Filling the alveolus with blood clot

Primary outcomes

  1. Bone regeneration

    Time frame: 12 weeks post-extraction

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

Secondary outcomes

  1. Visual Analogue Score (VAS)

    Time frame: 3, 7 and 15 days post-extraction

    Evolution of pain assessed by the visual analog scale (VAS). Values ranging 0 to 10 (0=no pain and 10=worst pain)

  2. Inflammation score

    Time frame: 3, 7 and 15 days post-extraction

    Evolution of inflammation evaluated by ordinal scale from 0 to 3 (0=no inflammation; 3=severe inflammation)

  3. Soft tissue healing index

    Time frame: 3, 7 and 15 days post-extraction

    Soft tissue healing index according to the scale of Laundry. Values ranging 1 to 5 (1=poor healing, 5=excellent healing)

  4. Changes in the dimension of the alveolar ridge

    Time frame: 12 weeks post-extraction

    Changes in the dimension of the alveolar ridge by means of superimposition of digital files of models of plaster after 12 weeks post-extraction

  5. Soft tissue histomorphometric changes

    Time frame: 12 weeks post-extraction

    • Soft tissue histomorphometric changes after evaluated by soft tissue biopsy

  6. Change in the bone dimensions of the alveolar ridge

    Time frame: 12 weeks post-extraction

    Change in the bone dimensions of the alveolar ridge evaluated by CBCT between the post-extraction day and the week 12 post-extraction.

  7. Change in bone density

    Time frame: 12 weeks post-extraction

    Change in bone density (Hounsfield units) evaluated by the CBCT at three different points between the post-extraction week and 12 weeks.

  8. Vitamin D levels

    Time frame: 12 weeks post-extraction

  9. Frequency of surgical and postsurgical complications

    Time frame: 12 weeks post-extraction

Sponsors and collaborators

Lead sponsor

Fundación Eduardo Anitua

Other

Registry information

Official study title

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.

Important dates

Study start
2020
Primary completion
2025
Study completion
2025
First posted
Jun 30, 2021
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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