Clinical trial NCT04093583: 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.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dental Implantation
Keywords: exodontia
PRGF
alveolar ridge preservation
Lead sponsor: Fundación Eduardo Anitua
Sponsor class: OTHER
First posted: 2019-09-18
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 alveolus. The primary endpoint is the bone regeneration measured in biopsies obtained from the regenerated alveolar bone.


Eligibility criteria: Inclusion Criteria:

* - 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 Criteria:

* - 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

Primary outcomes:
measure: Bone regeneration
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vitoria-Gasteiz
country: Spain
facility: Eduardo Anitua Private Clinic
state: Alava
city: Getxo
country: Spain
facility: Clinica dental Murias
state: Bizkaia
city: Galdakao
country: Spain
facility: Clinica Dental Loroño
state: Viscay
city: Getxo
country: Spain
facility: Clinica Ereaga
state: Viscay
city: A Coruña
country: Spain
facility: Clínica Dental González Mosquera
Study officials:
References: