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.

Dental Implantation Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04093583
• Other study ID #: FIBEA_04_EC_19_ALV
• Secondary ID: 2019-001167-75
• Status: Recruiting
• Phase: Phase 3
• Start date: November 7, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2021
• Source: Fundación Eduardo Anitua
• Contact: Mikel Allende, PhD, MBA
• Phone: 945 16 06 53
• Email: mikel.allende[@]bti-implant.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Implantation

Intervention

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

Locations

Country	Name	City	State
Spain	Clínica Dental González Mosquera	A Coruña
Spain	Clinica Dental Loroño	Galdakao	Viscay
Spain	Clinica dental Murias	Getxo	Bizkaia
Spain	Clinica Ereaga	Getxo	Viscay
Spain	Eduardo Anitua Private Clinic	Vitoria-Gasteiz	Alava

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Eduardo Anitua

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone regeneration	Quantity of new bone measured in bone biopsies obtained after alveolar ridge preservation	12 months