Clinical trial NCT04945629: Plasma Rich in Growth Factors in the Preservation of the Alveolar Ridge After Simple Molar Tooth Extractions.
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.
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: 2021-06-30
Enrollment: 44
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 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.


Eligibility criteria: 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

Primary outcomes:
measure: Bone regeneration
timeFrame: 12 weeks post-extraction
Secondary outcomes:
measure: Visual Analogue Score (VAS)
timeFrame: 3, 7 and 15 days post-extraction
measure: Inflammation score
timeFrame: 3, 7 and 15 days post-extraction
measure: Soft tissue healing index
timeFrame: 3, 7 and 15 days post-extraction
measure: Changes in the dimension of the alveolar ridge
timeFrame: 12 weeks post-extraction
measure: Soft tissue histomorphometric changes
timeFrame: 12 weeks post-extraction
measure: Change in the bone dimensions of the alveolar ridge
timeFrame: 12 weeks post-extraction
measure: Change in bone density
timeFrame: 12 weeks post-extraction
measure: Vitamin D levels
timeFrame: 12 weeks post-extraction
measure: Frequency of surgical and postsurgical complications
timeFrame: 12 weeks post-extraction
Other outcomes:
Locations:
city: Vitoria
country: Spain
facility: Clinica Eduardo Anitua
Study officials:
References: