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

NCT04945629 | Completed Phase 3

• 1 other identifier: BTIIMD_01_EC/20/Molares
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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.

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 weeks post-extraction

Secondary Outcomes (9)

• Visual Analogue Score (VAS)

  3, 7 and 15 days post-extraction

• Inflammation score

  3, 7 and 15 days post-extraction

• Soft tissue healing index

  3, 7 and 15 days post-extraction

• Changes in the dimension of the alveolar ridge

  12 weeks post-extraction

• Soft tissue histomorphometric changes

  12 weeks post-extraction

Study Arms (2)

Simple suture

ACTIVE COMPARATOR

Atraumatic exodontia followed by simple suture

Drug: Blood clot and simple suture

PRGF-Endoret

EXPERIMENTAL

Atraumatic exodontia followed by simple suture

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

Interventions

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

Filling of the alveolus with PRGF clot and fibrin plug.

PRGF-Endoret

Blood clot and simple suture DRUG

Filling the alveolus with blood clot

Simple suture

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación Eduardo Anitua: lead

Study Sites (1)

Clinica Eduardo Anitua

Vitoria-Gasteiz, Spain

Location

MeSH Terms

Interventions

Blood Coagulation

Intervention Hierarchy (Ancestors)

Hemostasis; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

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: June 15, 2021
• First Posted: June 30, 2021
• Study Start: September 2, 2020
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: February 25, 2025

Record last verified: 2025-02

Locations

ES (1)