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

Dental Implantation Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04945629
• Other study ID #: BTIIMD_01_EC/20/Molares
• Status: Recruiting
• Phase: Phase 3
• Start date: September 2, 2020
• Est. completion date: January 31, 2024

Study information

• Verified date: July 2022
• Source: Fundación Eduardo Anitua
• Contact: Mikel Allende, PhD
• Phone: +34945160653
• Email: mikel.allende[@]bti-implant.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Implantation

Intervention

Drug:
• Alveolar ridge preservation with a PRP (PRGF-Endoret)
Filling of the alveolus with PRGF clot and fibrin plug.
• Blood clot and simple suture
Filling the alveolus with blood clot

Locations

Country	Name	City	State
Spain	Clinica Eduardo Anitua	Vitoria

Sponsors (1)

Lead Sponsor	Collaborator
Fundación Eduardo Anitua

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone regeneration	Quantity of new bone measured in bone biopsies obtained after alveolar ridge preservation	12 weeks post-extraction
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Soft tissue histomorphometric changes	- Soft tissue histomorphometric changes after evaluated by soft tissue biopsy	12 weeks post-extraction
Secondary	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
Secondary	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
Secondary	Vitamin D levels		12 weeks post-extraction
Secondary	Frequency of surgical and postsurgical complications		12 weeks post-extraction