Clínica Dental Eduardo Anitua
Vitoria-Gasteiz, Spain
Completed
NCT Number: NCT01465399
Plasma Rich in Growth Factors (PRGF-Endoret) in the Regeneration of Post-Extraction Sockets
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.
Completed
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Notify MeKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Plasma Rich in Growth Factors PRGF-Endoret
BiologicalConventional closure of the lesion
ProcedurePrimary outcomes
-
Percentage of regenerated post-extraction sockets
Time frame: 10-12 weeks
Secondary outcomes
-
Regenerated bone volume
Time frame: 10-12 weeks
Measurement of the regenerated bone volume at final follow-up in relation to the initial post-extraction socket total volume measured by CT-Scanner and expressed as a percentage.
-
Post-operative pain (VAS)
Time frame: 3, 7 and 15 days post-extraction
-
Soft Tissue Healing Index
Time frame: 3, 7 and 15 days post-extraction
-
Inflammation
Time frame: 3, 7 and 15 days post-extraction
Using a specific 0 to 3 Inflammation Score
-
Adverse events or complications
Time frame: 10-12 weeks
Sponsors and collaborators
Lead sponsor
Fundación Eduardo Anitua
Other
Registry information
Official study 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
Important dates
- Study start
- 2011
- Primary completion
- 2012
- Study completion
- 2012
- First posted
- Nov 4, 2011
- Registry last updated
- Aug 23, 2021
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.