Status:
COMPLETED
Randomized Clinical Trial, Conventional Treatment-controlled, Studying the Efficacy of Plasma Rich in Growth Factor (PRGF®) in Alveolar Ridge Preservation After Simple Exodontia in the Anterior Region of Maxilla.
Lead Sponsor:
Fundación Eduardo Anitua
Conditions:
Dental Implantation
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This RCT aims to study the efficacy and safety of PRGF-Endoret in alveolar ridge preservation in the aesthetic zone. The control group is the spontaneous healing occuring after the suturing of the alv...
Eligibility Criteria
Inclusion
- \- Subjects of both sexes with an age greater than or equal to 18 years.
- Clinical indication for a simple exodontia in the aesthetic zone (from left 2nd premolar to the right 2nd premolar in the maxilla).
- Need of a dental implant placement in the extraction site.
- Availability to follow-up during the treatment period
- Subjects with non-active periodontal disease.
- Buccal dehiscence \< than 25% in the vestibular table
Exclusion
- \- Presence of an active infection
- Loss of any plate of the socket
- Severe inflammation in the area of the exodontia previous to the intervention
- Have previous diagnosis of a coagulopathy.
- Have previous diagnosis of any autoinmune disease.
- Have received radiotherapy, chemotherapy or immunosuppressive treatments, systemic corticosteroids and/or anticoagulants the 30 days prior to inclusion
- Regular treatment with AINES or other antiinflammatory drugs
- Previous history of chronic hepatitis or heatic cirrhosis
- Positive markers for VHC, AgHBs, VIH I/II or Treponema pallidum
- Uncontrolled diabetes mellitus (Glycosylated hemoglobin higher than 9%)
- Subjects submitted to hemodyalisis
- Presence of malignant tumour, haemangiomas or angioma in the exodontia region.
- Previous history of ischemic cardiopathy in the last year.
- Pregnancy or womens in childbearing age who do not take contraception measures.
- Nursing womens
- Metabolic bone disease
- Ongoing treatment with biphosphonates both through oral or intravenous administration
- Smoking habits (\> 10 cigarrettes/day)
- In general, any disability to participate in the study
Key Trial Info
Start Date :
November 7 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 29 2025
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04093583
Start Date
November 7 2019
End Date
January 29 2025
Last Update
February 25 2025
Active Locations (5)
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1
Eduardo Anitua Private Clinic
Vitoria-Gasteiz, Alava, Spain, 01005
2
Clinica dental Murias
Getxo, Bizkaia, Spain, 48930
3
Clinica Dental Loroño
Galdakao, Viscay, Spain, 48960
4
Clinica Ereaga
Getxo, Viscay, Spain, 48991