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

Phase 3

Completed

• Conditions: Dental Implantation
• Interventions: Drug: Blood clot and simple suture; Drug: Alveolar ridge preservation with a PRP (PRGF-Endoret)

• Registration Number: NCT04945629
• Lead Sponsor: Fundación Eduardo Anitua

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-02
• Study First Submitted: 2021-06-15
• Study First Submitted QC: 2021-06-22
• Study First Posted: 2021-06-30
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Simple suture	Blood clot and simple suture	Atraumatic exodontia followed by simple suture
PRGF-Endoret	Alveolar ridge preservation with a PRP (PRGF-Endoret)	Atraumatic exodontia followed by simple suture

Primary Outcome Measures

Name	Time	Method
Bone regeneration	12 weeks post-extraction	Quantity of new bone measured in bone biopsies obtained after alveolar ridge preservation

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Clinica Eduardo Anitua; 🇪🇸 Vitoria, Spain