Clinical trial NCT01465399: Plasma Rich in Growth Factors (PRGF-Endoret) in the Regeneration of Post-Extraction Sockets
Official title: Randomized Clinical Trial, Controlled With Conventional Treatment, of Efficacy and Safety of Plasma Rich in Growth Factors (PRGF-Endoret) in the Regeneration of Post-extraction Sockets in Simple Extractions of Molars in the Mandible
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-Extraction Sockets Healing
Lead sponsor: Fundación Eduardo Anitua
Sponsor class: OTHER
First posted: 2011-11-04
Enrollment: 60
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: Immediately following tooth removal, a healing process begins that affects the eventual alveolar bone volume and architecture of the alveolar ridge. Satisfactory and timely healing are essential to obtain ideal functional reconstruction. Traumatic removal of a tooth, or a poor healing response, may lead to excessive bone loss delaying tooth replacement, requiring expensive and time-consuming reconstructive surgeries, or even the inability to be corrected. The Plasma Rich in Growth Factors (PRGF-Endoret) has shown its therapeutic potential effect to minimize the consequences of this aggression, promoting the regeneration of both hard and soft involved tissues.


Eligibility criteria: Inclusion Criteria:

* subjects of both genders and ≥ 18 years old
* Indication of a simple one molar extraction in the mandible.
* Possibility of observation during the follow-up period.

Exclusion Criteria:

* Unerupted third molars or with horizontal inclination.
* Severe swelling prior to surgery in the areas designated for extraction.
* Suffering an alteration or a serious hematologic disease.
* Be currently undergoing or have received radiotherapy, chemotherapy or immunosuppressive therapy, corticosteroids and/or anticoagulants 30 days prior to inclusion
* In regular treatment with NSAIDs or other anti-inflammatory drugs.
* History of chronic hepatitis or cirrhosis.
* Diabetes mellitus with poor metabolic control (glycosylated hemoglobin \>9%)
* Patients undergoing dialysis.
* Presence of malignant tumors, hemangiomas or angiomas in the extraction area.
* History of ischemic heart disease in the last year.
* Pregnancy or planned pregnancy during the study follow-up period.
* Metabolic Bone Disease.
* Patients taking bisphosphonates both orally and intravenously.
* In general, any inability to participate in the study.

Primary outcomes:
measure: Percentage of regenerated post-extraction sockets
timeFrame: 10-12 weeks
Secondary outcomes:
measure: Regenerated bone volume
timeFrame: 10-12 weeks
measure: Post-operative pain (VAS)
timeFrame: 3, 7 and 15 days post-extraction
measure: Soft Tissue Healing Index
timeFrame: 3, 7 and 15 days post-extraction
measure: Inflammation
timeFrame: 3, 7 and 15 days post-extraction
measure: Adverse events or complications
timeFrame: 10-12 weeks
Other outcomes:
Locations:
city: Vitoria
country: Spain
facility: Clínica Dental Eduardo Anitua
Study officials:
affiliation: Clinica Dental Eduardo Anitua
name: Eduardo Anitua, MD, DDS, PhD
role: STUDY_DIRECTOR
References: