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.

Phase 3

Completed

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

• Registration Number: NCT04093583
• Lead Sponsor: Fundación Eduardo Anitua

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-09-16
• Study First Submitted QC: 2019-09-16
• Study First Posted: 2019-09-18
• Study Start: 2019-11-07
• Primary Completion: 2025-01-29
• Study Completion: 2025-01-29
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simple suture	Exodontia	-
PRGF-Endoret	Exodontia	-
PRGF-Endoret	Alveolar ridge preservation with a PRP (PRGF-Endoret)	-
PRGF-Endoret	Preparation of PRGF using Endoret technology	-

Primary Outcome Measures

Name	Time	Method
Bone regeneration	12 months	Quantity of new bone measured in bone biopsies obtained after alveolar ridge preservation

Trial Locations

Locations (5)

Eduardo Anitua Private Clinic; 🇪🇸 Vitoria-Gasteiz, Alava, Spain

Clinica dental Murias; 🇪🇸 Getxo, Bizkaia, Spain

Clinica Dental Loroño; 🇪🇸 Galdakao, Viscay, Spain

Clinica Ereaga; 🇪🇸 Getxo, Viscay, Spain

Clínica Dental González Mosquera; 🇪🇸 A Coruña, Spain