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.

Fundación Eduardo Anitua

Status and phase

Completed

Phase 3

Conditions

Dental Implantation

Treatments

Device: Preparation of PRGF using Endoret technology

Drug: Alveolar ridge preservation with a PRP (PRGF-Endoret)

Procedure: Exodontia

Study type

Interventional

Funder types

Other

Identifiers

NCT04093583

2019-001167-75 (EudraCT Number)

FIBEA_04_EC_19_ALV

Details and patient eligibility

About

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.

Enrollment

46 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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