Post-Extraction Sockets HealingNCT01465399
Plasma Rich in Growth Factors (PRGF-Endoret) in the Regeneration of Post-Extraction Sockets
A study testing Plasma Rich in Growth Factors PRGF-Endoret and Conventional closure of the lesion in people with Post-Extraction Sockets Healing, run by Fundación Eduardo Anitua at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-Extraction Sockets Healing
- What is being tested?
- Plasma Rich in Growth Factors PRGF-Endoret and Conventional closure of the lesion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2011to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Post-Extraction Sockets Healing
- Being tested
- Plasma Rich in Growth Factors PRGF-Endoret, Conventional closure of the lesion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plasma Rich in Growth Factors PRGF-EndoretBiological
Conventional closure of the lesionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| PRGF-Endoret | Experimental | Not described Receives: Biological: Plasma Rich in Growth Factors PRGF-Endoret |
| Conventional treatment | Active comparator | Not described Receives: Procedure: Conventional closure of the lesion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of regenerated post-extraction sockets
Measured: 10-12 weeks
Secondary outcomes (5)
Regenerated bone volume
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.
Measured: 10-12 weeks
Post-operative pain (VAS)
Measured: 3, 7 and 15 days post-extraction
Soft Tissue Healing Index
Measured: 3, 7 and 15 days post-extraction
Inflammation
Using a specific 0 to 3 Inflammation Score
Measured: 3, 7 and 15 days post-extraction
Adverse events or complications
Measured: 10-12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2011 (estimated)
- Study startOct 2011
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Extraction Sockets HealingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Eduardo Anitua
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eduardo Anitua, MD, DDS, PhD, Study director, Clinica Dental Eduardo Anitua
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01465399
- Sponsor's protocol ID
- FIBEA-01-EC/11/ALV
- Other IDs
- 2019-001167-75, 2019
- Status last verified
- Aug 2021
- First submitted
- 27 Oct 2011
- Last updated
- 23 Aug 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01465399
- Acronym / sponsor ID
- FIBEA-01-EC/11/ALV
- Conditions
- Post-Extraction Sockets Healing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Fundación Eduardo AnituaUniversity, hospital or other
- Study start
- Oct 2011 (actual)
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 4 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRGF-Endoret | Experimental | Biological: Plasma Rich in Growth Factors PRGF-Endoret |
| Conventional treatment | Active comparator | Procedure: Conventional closure of the lesion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plasma Rich in Growth Factors PRGF-Endoret | Biological | PRGF-Endoret |
| Conventional closure of the lesion | Procedure or surgery | Conventional treatment |
Primary outcome
Percentage of regenerated post-extraction sockets
Time frame: 10-12 weeks
5 secondary outcomes
Regenerated bone volume
Time frame: 10-12 weeks
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
Adverse events or complications
Time frame: 10-12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo Anitua, MD, DDS, PhD study director
Clinica Dental Eduardo Anitua
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plasma Rich in Growth Factors PRGF-Endoret and Conventional closure of the lesion in people with Post-Extraction Sockets Healing, run by Fundación Eduardo Anitua at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of regenerated post-extraction sockets (time frame: 10-12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2021; AzTrials last refreshed its copy on 7 Nov 2026.