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.

NCT04093583 | Completed Phase 3

• 2 other identifiers: FIBEA_04_EC_19_ALV2019-001167-75
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Dental Implantation

Keywords

exodontia; PRGF; alveolar ridge preservation

Outcome Measures

Primary Outcomes (1)

• Bone regeneration

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

  12 months

Study Arms (2)

Simple suture

ACTIVE COMPARATOR

Procedure: Exodontia

PRGF-Endoret

EXPERIMENTAL

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

Interventions

Exodontia PROCEDURE

Atraumatic exodontia followed by simple suture

PRGF-Endoret; Simple suture

Alveolar ridge preservation with a PRP (PRGF-Endoret) DRUG

Filling of the alveolus with PRGF clot and fibrin plug.

PRGF-Endoret

Preparation of PRGF using Endoret technology DEVICE

Preparation of PRGF using Endoret technology following manufacturer instructions

PRGF-Endoret

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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

You may not qualify if:

• \- 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.
• 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

Sponsors & Collaborators

• Fundación Eduardo Anitua: lead

Study Sites (5)

Eduardo Anitua Private Clinic

Vitoria-Gasteiz, Alava, 01005, Spain

Location

Clinica dental Murias

Getxo, Bizkaia, 48930, Spain

Location

Clinica Dental Loroño

Galdakao, Viscay, 48960, Spain

Location

Clinica Ereaga

Getxo, Viscay, 48991, Spain

Location

Clínica Dental González Mosquera

A Coruña, 15005, Spain

Location

MeSH Terms

Interventions

Tooth Extraction

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures; Surgical Procedures, Operative; Dentistry

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2019
• First Posted: September 18, 2019
• Study Start: November 7, 2019
• Primary Completion: January 29, 2025
• Study Completion: January 29, 2025
• Last Updated: February 25, 2025

Record last verified: 2025-02

Locations

ES (5)