Dental ImplantationPhase 3NCT04093583
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.
A Phase 3 study testing Exodontia, Alveolar ridge preservation with a PRP (PRGF-Endoret) and Preparation of PRGF using Endoret technology in people with Dental Implantation, run by Fundación Eduardo Anitua at 5 sites in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Implantation
- What is being tested?
- Exodontia, Alveolar ridge preservation with a PRP (PRGF-Endoret) and Preparation of PRGF using Endoret technology
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 5 sitesSpain
- Study dates
- 7 Nov 2019to 29 Jan 2025
- Phase
- Phase 3
- 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 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
Who cannot join
- - 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
Show all 19Show fewer
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Clínica Dental González Mosquera
A Coruña, 15005
Clinica Dental Loroño
Galdakao, Viscay, 48960
Clinica dental Murias
Getxo, Bizkaia, 48930
Clinica Ereaga
Getxo, Viscay, 48991
Eduardo Anitua Private Clinic
Vitoria-Gasteiz, Alava, 01005
About this study
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.
- Conditions
- Dental Implantation
- Being tested
- Exodontia, Alveolar ridge preservation with a PRP (PRGF-Endoret), Preparation of PRGF using Endoret technology
- Keywords
- exodontia, PRGF, alveolar ridge preservation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExodontiaProcedure or surgery
Atraumatic exodontia followed by simple suture
Alveolar ridge preservation with a PRP (PRGF-Endoret)Drug
Filling of the alveolus with PRGF clot and fibrin plug.
Preparation of PRGF using Endoret technologyDevice
Preparation of PRGF using Endoret technology following manufacturer instructions
| Study group | Role | What they receive |
|---|---|---|
| Simple suture | Active comparator | Not described Receives: Procedure: Exodontia |
| PRGF-Endoret | Experimental | Not described Receives: Procedure: Exodontia; Drug: Alveolar ridge preservation with a PRP (PRGF-Endoret); Device: Preparation of PRGF using Endoret technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone regeneration
Quantity of new bone measured in bone biopsies obtained after alveolar ridge preservation
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start7 Nov 2019
- Primary completion29 Jan 2025
- Study completion29 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantationStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Eduardo Anitua
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04093583
- Sponsor's protocol ID
- FIBEA_04_EC_19_ALV
- Other IDs
- 2019-001167-75, 2019
- Status last verified
- Feb 2025
- First submitted
- 16 Sep 2019
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04093583
- Acronym / sponsor ID
- FIBEA_04_EC_19_ALV
- Conditions
- Dental Implantation
- Keywords
- exodontia, PRGF, alveolar ridge preservation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Fundación Eduardo AnituaUniversity, hospital or other
- Study start
- 7 Nov 2019 (actual)
- Primary completion
- 29 Jan 2025 (actual)
- Study completion
- 29 Jan 2025 (actual)
- First posted
- 18 Sep 2019 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Simple suture | Active comparator | Procedure: Exodontia |
| PRGF-Endoret | Experimental | Procedure: Exodontia, Drug: Alveolar ridge preservation with a PRP (PRGF-Endoret), Device: Preparation of PRGF using Endoret technology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- - 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.
Key exclusion criteria (19 listed)
- - 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.
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 |
|---|---|---|
| ExodontiaAtraumatic exodontia followed by simple suture | Procedure or surgery | PRGF-Endoret, Simple suture |
| Alveolar ridge preservation with a PRP (PRGF-Endoret)Filling of the alveolus with PRGF clot and fibrin plug. | Drug | PRGF-Endoret |
| Preparation of PRGF using Endoret technologyPreparation of PRGF using Endoret technology following manufacturer instructions | Device | PRGF-Endoret |
Primary outcome
Bone regeneration
Time frame: 12 months
Quantity of new bone measured in bone biopsies obtained after alveolar ridge preservation
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 25 Feb 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Exodontia, Alveolar ridge preservation with a PRP (PRGF-Endoret) and Preparation of PRGF using Endoret technology in people with Dental Implantation, run by Fundación Eduardo Anitua at 5 sites 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 6 inclusion and 19 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 25 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Bone regeneration (time frame: 12 months). 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 25 Feb 2025.