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

Fundación Eduardo Anitua

Status and phase: Completed; Phase 3

Conditions: Dental Implantation

Treatments: Drug: Alveolar ridge preservation with a PRP (PRGF-Endoret); Drug: Blood clot and simple suture

Study type: Interventional

Funder types: Other

Identifiers

NCT04945629

BTIIMD_01_EC/20/Molares

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

Simple suture

Active Comparator group

Description:

Atraumatic exodontia followed by simple suture

Treatment:

Drug: Blood clot and simple suture

PRGF-Endoret

Experimental group

Description:

Atraumatic exodontia followed by simple suture

Treatment:

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