Dental ImplantationPhase 3NCT04945629
Plasma Rich in Growth Factors in the Preservation of the Alveolar Ridge After Simple Molar Tooth Extractions.
A Phase 3 study testing Alveolar ridge preservation with a PRP (PRGF-Endoret) and Blood clot and simple suture in people with Dental Implantation, run by Fundación Eduardo Anitua at 1 site in Spain.
Trial 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. 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?
- Alveolar ridge preservation with a PRP (PRGF-Endoret) and Blood clot and simple suture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- 2 Sep 2020to 31 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
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
- Conditions
- Dental Implantation
- Being tested
- Alveolar ridge preservation with a PRP (PRGF-Endoret), Blood clot and simple suture
- 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.
Alveolar ridge preservation with a PRP (PRGF-Endoret)Drug
Filling of the alveolus with PRGF clot and fibrin plug.
Blood clot and simple sutureDrug
Filling the alveolus with blood clot
| Study group | Role | What they receive |
|---|---|---|
| Simple suture | Active comparator | Atraumatic exodontia followed by simple suture Receives: Drug: Blood clot and simple suture |
| PRGF-Endoret | Experimental | Atraumatic exodontia followed by simple suture Receives: Drug: Alveolar ridge preservation with a PRP (PRGF-Endoret) |
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 weeks post-extraction
Secondary outcomes (9)
Visual Analogue Score (VAS)
Evolution of pain assessed by the visual analog scale (VAS). Values ranging 0 to 10 (0=no pain and 10=worst pain)
Measured: 3, 7 and 15 days post-extraction
Inflammation score
Evolution of inflammation evaluated by ordinal scale from 0 to 3 (0=no inflammation; 3=severe inflammation)
Measured: 3, 7 and 15 days post-extraction
Soft tissue healing index
Soft tissue healing index according to the scale of Laundry. Values ranging 1 to 5 (1=poor healing, 5=excellent healing)
Measured: 3, 7 and 15 days post-extraction
Changes in the dimension of the alveolar ridge
Changes in the dimension of the alveolar ridge by means of superimposition of digital files of models of plaster after 12 weeks post-extraction
Measured: 12 weeks post-extraction
Soft tissue histomorphometric changes
- Soft tissue histomorphometric changes after evaluated by soft tissue biopsy
Measured: 12 weeks post-extraction
Change in the bone dimensions of the alveolar ridge
Change in the bone dimensions of the alveolar ridge evaluated by CBCT between the post-extraction day and the week 12 post-extraction.
Measured: 12 weeks post-extraction
Change in bone density
Change in bone density (Hounsfield units) evaluated by the CBCT at three different points between the post-extraction week and 12 weeks.
Measured: 12 weeks post-extraction
Vitamin D levels
Measured: 12 weeks post-extraction
Frequency of surgical and postsurgical complications
Measured: 12 weeks post-extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start2 Sep 2020
- Primary completion31 Jan 2025
- Study completion31 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
- 44 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
- NCT04945629
- Sponsor's protocol ID
- BTIIMD_01_EC/20/Molares
- Status last verified
- Feb 2025
- First submitted
- 15 Jun 2021
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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, Controlled by Conventional Treatment, of Plasma Rich in Growth Factors (PRGF®) in the Preservation of the Alveolar Ridge After Simple Molar Tooth Extractions.
- ClinicalTrials.gov ID
- NCT04945629
- Acronym / sponsor ID
- BTIIMD_01_EC/20/Molares
- Conditions
- Dental Implantation
- Keywords
- exodontia, PRGF, Alveolar Ridge preservation
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Fundación Eduardo AnituaUniversity, hospital or other
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 30 Jun 2021 (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 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.
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 | Drug: Blood clot and simple sutureAtraumatic exodontia followed by simple suture |
| PRGF-Endoret | Experimental | Drug: Alveolar ridge preservation with a PRP (PRGF-Endoret)Atraumatic exodontia followed by simple suture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (24 listed)
- Third molars
- Active periodontal disease
- Simultaneous extraction of two adjacent pieces in the same quadrant
- Oral dehiscence ≥ 25%
- Alveolus depth <7mm
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 |
|---|---|---|
| Alveolar ridge preservation with a PRP (PRGF-Endoret)Filling of the alveolus with PRGF clot and fibrin plug. | Drug | PRGF-Endoret |
| Blood clot and simple sutureFilling the alveolus with blood clot | Drug | Simple suture |
Primary outcome
Bone regeneration
Time frame: 12 weeks post-extraction
Quantity of new bone measured in bone biopsies obtained after alveolar ridge preservation
9 secondary outcomes
Visual Analogue Score (VAS)
Time frame: 3, 7 and 15 days post-extraction
Inflammation score
Time frame: 3, 7 and 15 days post-extraction
Soft tissue healing index
Time frame: 3, 7 and 15 days post-extraction
Changes in the dimension of the alveolar ridge
Time frame: 12 weeks post-extraction
Soft tissue histomorphometric changes
Time frame: 12 weeks post-extraction
Change in the bone dimensions of the alveolar ridge
Time frame: 12 weeks post-extraction
Change in bone density
Time frame: 12 weeks post-extraction
Vitamin D levels
Time frame: 12 weeks post-extraction
Frequency of surgical and postsurgical complications
Time frame: 12 weeks post-extraction
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.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Alveolar ridge preservation with a PRP (PRGF-Endoret) and Blood clot and simple suture in people with Dental Implantation, 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 5 inclusion and 24 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 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.
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 weeks post-extraction). 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.