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

Randomized Clinical Trial, Controlled by Conventional Treatment, of Plasma Rich in Growth Factors (PRGF®) in the Preservation of the Alveolar Ridge After Simple Molar Tooth Extractions.

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Implantation
• Intervention / Treatment: Drug: Alveolar ridge preservation with a PRP (PRGF-Endoret); Drug: Blood clot and simple suture

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Mikel Allende, PhD; Phone Number: 257 +34945160653; Email: mikel.allende@bti-implant.es

Study Locations

• Spain
  • Vitoria, Spain
    • Recruiting
    • Clinica Eduardo Anitua
    • Contact: Mikel Allende; Phone Number: +34945160653; Email: mikel.allende@bti-implant.es
    • Sub-Investigator: Adriana Montalvillo, DDS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Simple suture; Atraumatic exodontia followed by simple suture	Drug: Blood clot and simple suture; Filling the alveolus with blood clot
Experimental: PRGF-Endoret; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bone regeneration	Quantity of new bone measured in bone biopsies obtained after alveolar ridge preservation	12 weeks post-extraction

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analogue Score (VAS)	Evolution of pain assessed by the visual analog scale (VAS). Values ranging 0 to 10 (0=no pain and 10=worst pain)	3, 7 and 15 days post-extraction
Inflammation score	Evolution of inflammation evaluated by ordinal scale from 0 to 3 (0=no inflammation; 3=severe inflammation)	3, 7 and 15 days post-extraction
Soft tissue healing index	Soft tissue healing index according to the scale of Laundry. Values ranging 1 to 5 (1=poor healing, 5=excellent healing)	3, 7 and 15 days post-extraction
Changes in the dimension of the alveolar ridge	Changes in the dimension of the alveolar ridge by means of superimposition of digital files of models of plaster after 12 weeks post-extraction	12 weeks post-extraction
Soft tissue histomorphometric changes	- Soft tissue histomorphometric changes after evaluated by soft tissue biopsy	12 weeks post-extraction
Change in the bone dimensions of the alveolar ridge	Change in the bone dimensions of the alveolar ridge evaluated by CBCT between the post-extraction day and the week 12 post-extraction.	12 weeks post-extraction
Change in bone density	Change in bone density (Hounsfield units) evaluated by the CBCT at three different points between the post-extraction week and 12 weeks.	12 weeks post-extraction
Vitamin D levels		12 weeks post-extraction
Frequency of surgical and postsurgical complications		12 weeks post-extraction

Collaborators and Investigators

• Sponsor: Fundación Eduardo Anitua

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2020
• Primary Completion (Anticipated): January 31, 2023
• Study Completion (Anticipated): January 31, 2024

Study Registration Dates

• First Submitted: June 15, 2021
• First Submitted That Met QC Criteria: June 22, 2021
• First Posted (Actual): June 30, 2021

Study Record Updates

• Last Update Posted (Actual): July 7, 2022
• Last Update Submitted That Met QC Criteria: July 6, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: PRGF; exodontia; Alveolar Ridge preservation
• Other Study ID Numbers: BTIIMD_01_EC/20/Molares

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No