Alveolar Bone ResorptionNCT06900036
Radiographic Evaluation in Alveolar Preservation Using Platelet-rich Fibrin. Randomized Controlled Trial
A study testing Platelet-Rich Fibrin (PRF) Application for Alveolar Preservation in people with Alveolar Bone Resorption and Preserving the Alveolar Ridge, run by Universidad Católica de Cuenca at 1 site in Ecuador.
Trial summary
This randomized controlled trial is designed to assess the use of platelet-rich fibrin (PRF), a biomaterial derived from a participant's own blood, in alveolar ridge preservation following premolar extraction for orthodontic purposes. Read more about this study
- Who is it for?
- Ages 17 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Resorption, Preserving the Alveolar Ridge
- What is being tested?
- Platelet-Rich Fibrin (PRF) Application for Alveolar Preservation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteEcuador
- Study dates
- 1 Mar 2023to 20 Nov 2024
- 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 17 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy individuals with no systemic diseases.
- Age range: 17 to 38 years old.
- Orthodontic indication for premolar extraction (two maxillary or two mandibular premolars).
- Candidates for orthognathic surgery or extraction of impacted/retained teeth (e.g., third molars with a relationship to critical anatomical structures).
- Clinical justification for CBCT imaging instead of standard radiographic -techniques.
Who cannot join
- Patients with systemic diseases that may alter periodontal therapy outcomes.
- Platelet count below 200,000 mm³.
- Immunosuppressed patients.
- Pregnant or lactating women.
- Smokers.
- Patients taking medications that interfere with healing (e.g., bisphosphonates, corticosteroids, anticoagulants).
Trial locations and contacts
1 site in 1 country.
About this study
This randomized controlled trial is designed to assess the use of platelet-rich fibrin (PRF), a biomaterial derived from a participant's own blood, in alveolar ridge preservation following premolar extraction for orthodontic purposes. Participants aged 17 to 38 years requiring premolar extractions will be randomly assigned to receive either PRF application or natural healing without intervention. Cone beam computed tomography (CBCT) will be used to evaluate changes in alveolar bone dimensions and density at 30 and 120 days post-extraction. Measurements will be taken at standardized vertical levels (1 mm, 3 mm, and 5 mm apical to the crest) to analyze bone height, width, and density over time.
Read the detailed description
This study is a randomized controlled clinical trial designed to investigate the application of platelet-rich fibrin (PRF) in post-extraction sites following orthodontically indicated premolar removals. PRF is prepared from autologous blood and applied to extraction sockets in the experimental group, while the control group undergoes standard physiological healing. Cone beam computed tomography (CBCT) will be used to obtain quantitative data on alveolar bone structure at baseline, 30 days, and 120 days post-extraction. The study will assess changes in bone height, horizontal ridge width at defined depths, and bone tissue density using standardized imaging protocols. This design allows for objective comparison between treated and untreated sites.
- Being tested
- Platelet-Rich Fibrin (PRF) Application for Alveolar Preservation
- Keywords
- Bone Regeneration, Tooth Socket, oral surgery, Platelet-rich fibrin, CBCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-Rich Fibrin (PRF) Application for Alveolar PreservationProcedure or surgery
This intervention involves the application of platelet-rich fibrin (PRF) in the extraction socket following premolar extraction to assess its effectiveness in alveolar bone preservation. PRF is a biological autologous material derived from the patient's own blood, promoting bone regeneration, wound healing, and tissue repair.
| Study group | Role | What they receive |
|---|---|---|
| Platelet-Rich Fibrin (PRF) Application for Alveolar Preservation | Experimental | This arm involves the application of Platelet-Rich Fibrin (PRF) immediately after premolar extraction to evaluate its effectiveness in preserving alveolar bone structure and enhancing bone regeneration. PRF is a natural, autologous biomaterial obtained from the patient's own blood, promoting wound healing, bone preservation, and tissue regeneration. Receives: Procedure: Platelet-Rich Fibrin (PRF) Application for Alveolar Preservation |
| Control Group - Natural Healing (No PRF Application) | No intervention | This arm represents the control group, where participants undergo standard premolar extraction without the application of platelet-rich fibrin (PRF). This allows for a direct comparison to assess the effectiveness of PRF in preserving alveolar bone and enhancing healing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in alveolar bone height (mm) at 30 and 120 days post-extraction as measured by CBCT
Alveolar bone height will be measured from the most apical point of the socket to the crestal margin using CBCT (cone beam computed tomography) scans at baseline (day of extraction), 30 days, and 120 days post-extraction. Measurements will be recorded in millimeters and compared between PRF-treated sites and control sites (no PRF). The mean difference in height over time will be calculated within and between groups.
Measured: Baseline (immediately post-extraction), 30 days, and 120 days post-extraction.
Secondary outcomes (2)
Change in alveolar bone depth (mm) at 1 mm, 3 mm, and 5 mm from crest, at 30 and 120 days post-extraction
Bone depth (horizontal ridge width) will be assessed at three standardized vertical levels (1 mm, 3 mm, and 5 mm from the crestal margin) using CBCT imaging. Measurements will be performed bucco-lingually. Data will be reported as mean ± SD per time point and compared between PRF and control groups.
Measured: Baseline, 30 days, and 120 days post-extraction.
Bone tissue density (HU) at 30 and 120 days post-extraction measured via CBCT
Bone density will be measured using Hounsfield Units (HU) within the center of the extraction socket. CBCT scans will be analyzed using imaging software calibrated for HU estimation. The average HU values will be compared between PRF-treated and control sockets to assess mineralization and bone quality.
Measured: Baseline, 30 days, and 120 days post-extraction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2025
- Study start1 Mar 2023
- Primary completion28 Sep 2023
- Study completion20 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alveolar Bone ResorptionStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica de Cuenca
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ROCIO MAGDALENA MOLINA BARAHONA, Universidad Católica de Cuenca
- Investigators
- ROCIO MAGDALENA MOLINA BARAHONA, Doctor of Dental Surgery (DDS), Principal investigator, Universidad Católica de CuencaRENATA A AVECILLAS RODAS, Doctor of Dental Surgery (DDS), Study chair, Universidad Católica de Cuenca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06900036
- Sponsor's protocol ID
- CEISH - UCACUE - 031
- Status last verified
- Mar 2025
- First submitted
- 15 Mar 2025
- Last updated
- 28 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Radiographic CBCT images (de-identified) Clinical measurements (bone height, depth, and quality) Demographic information (age, sex, general health status) Outcome measures (PRF effectiveness in alveolar preservation) Access Criteria: Available to qualified researchers upon request Requires a formal data access request and institutional agreement Compliance with ethical and privacy regulations Time Frame: Available upon study publication Accessible for at least five years post-publication Storage: Data will be stored in a secure university repository and potentially in public research databases. This plan ensures transparency, collaboration, and compliance with ICMJE guidelines for clinical research.
Publications
Simon BI, Von Hagen S, Deasy MJ, Faldu M, Resnansky D. Changes in alveolar bone height and width following ridge augmentation using bone graft and membranes. J Periodontol. 2000 Nov;71(11):1774-91. doi: 10.1902/jop.2000.71.11.1774.
PubMed 11128929Anwandter A, Bohmann S, Nally M, Castro AB, Quirynen M, Pinto N. Dimensional changes of the post extraction alveolar ridge, preserved with Leukocyte- and Platelet Rich Fibrin: A clinical pilot study. J Dent. 2016 Sep;52:23-9. doi: 10.1016/j.jdent.2016.06.005. Epub 2016 Jun 20.
PubMed 27338946Alzahrani AA, Murriky A, Shafik S. Influence of platelet rich fibrin on post-extraction socket healing: A clinical and radiographic study. Saudi Dent J. 2017 Oct;29(4):149-155. doi: 10.1016/j.sdentj.2017.07.003. Epub 2017 Aug 2.
PubMed 29033524Hauser F, Gaydarov N, Badoud I, Vazquez L, Bernard JP, Ammann P. Clinical and histological evaluation of postextraction platelet-rich fibrin socket filling: a prospective randomized controlled study. Implant Dent. 2013 Jun;22(3):295-303. doi: 10.1097/ID.0b013e3182906eb3.
PubMed 23644909
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic Evaluation in Alveolar Preservation Using Platelet-rich Fibrin. Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06900036
- Acronym / sponsor ID
- CEISH - UCACUE - 031
- Keywords
- Bone Regeneration, Tooth Socket, oral surgery, Platelet-rich fibrin, CBCT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Universidad Católica de CuencaUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 28 Sep 2023 (actual)
- Study completion
- 20 Nov 2024 (actual)
- First posted
- 28 Mar 2025 (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 controlled trial is designed to assess the use of platelet-rich fibrin (PRF), a biomaterial derived from a participant's own blood, in alveolar ridge preservation following premolar extraction for orthodontic purposes. Participants aged 17 to 38 years requiring premolar extractions will be randomly assigned to receive either PRF application or natural healing without intervention. Cone beam computed tomography (CBCT) will be used to evaluate changes in alveolar bone dimensions and density at 30 and 120 days post-extraction. Measurements will be taken at standardized vertical levels (1 mm, 3 mm, and 5 mm apical to the crest) to analyze bone height, width, and density over time.
Detailed description
This study is a randomized controlled clinical trial designed to investigate the application of platelet-rich fibrin (PRF) in post-extraction sites following orthodontically indicated premolar removals. PRF is prepared from autologous blood and applied to extraction sockets in the experimental group, while the control group undergoes standard physiological healing. Cone beam computed tomography (CBCT) will be used to obtain quantitative data on alveolar bone structure at baseline, 30 days, and 120 days post-extraction. The study will assess changes in bone height, horizontal ridge width at defined depths, and bone tissue density using standardized imaging protocols. This design allows for objective comparison between treated and untreated sites.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet-Rich Fibrin (PRF) Application for Alveolar Preservation | Experimental | Procedure: Platelet-Rich Fibrin (PRF) Application for Alveolar PreservationThis arm involves the application of Platelet-Rich Fibrin (PRF) immediately after premolar extraction to evaluate its effectiveness in preserving alveolar bone structure and enhancing bone regeneration. PRF is a natural, autologous biomaterial obtained from the patient's own blood, promoting wound healing, bone preservation, and tissue regeneration. |
| Control Group - Natural Healing (No PRF Application) | No intervention | –This arm represents the control group, where participants undergo standard premolar extraction without the application of platelet-rich fibrin (PRF). This allows for a direct comparison to assess the effectiveness of PRF in preserving alveolar bone and enhancing healing. |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy individuals with no systemic diseases.
- Age range: 17 to 38 years old.
- Orthodontic indication for premolar extraction (two maxillary or two mandibular premolars).
- Candidates for orthognathic surgery or extraction of impacted/retained teeth (e.g., third molars with a relationship to critical anatomical structures).
- Clinical justification for CBCT imaging instead of standard radiographic -techniques.
Key exclusion criteria (6 listed)
- Patients with systemic diseases that may alter periodontal therapy outcomes.
- Platelet count below 200,000 mm³.
- Immunosuppressed patients.
- Pregnant or lactating women.
- Smokers.
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 |
|---|---|---|
| Platelet-Rich Fibrin (PRF) Application for Alveolar PreservationThis intervention involves the application of platelet-rich fibrin (PRF) in the extraction socket following premolar extraction to assess its effectiveness in alveolar bone preservation. PRF is a biological autologous material derived from the patient's own blood, promoting bone regeneration, wound healing, and tissue repair. | Procedure or surgery | Platelet-Rich Fibrin (PRF) Application for Alveolar Preservation |
Primary outcome
Change in alveolar bone height (mm) at 30 and 120 days post-extraction as measured by CBCT
Time frame: Baseline (immediately post-extraction), 30 days, and 120 days post-extraction.
Alveolar bone height will be measured from the most apical point of the socket to the crestal margin using CBCT (cone beam computed tomography) scans at baseline (day of extraction), 30 days, and 120 days post-extraction. Measurements will be recorded in millimeters and compared between PRF-treated sites and control sites (no PRF). The mean difference in height over time will be calculated within and between groups.
2 secondary outcomes
Change in alveolar bone depth (mm) at 1 mm, 3 mm, and 5 mm from crest, at 30 and 120 days post-extraction
Time frame: Baseline, 30 days, and 120 days post-extraction.
Bone tissue density (HU) at 30 and 120 days post-extraction measured via CBCT
Time frame: Baseline, 30 days, and 120 days 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 28 Mar 2025.
- Background: PubMed 11128929Simon BI, Von Hagen S, Deasy MJ, Faldu M, Resnansky D. Changes in alveolar bone height and width following ridge augmentation using bone graft and membranes. J Periodontol. 2000 Nov;71(11):1774-91. doi: 10.1902/jop.2000.71.11.1774.
- Background: PubMed 27338946Anwandter A, Bohmann S, Nally M, Castro AB, Quirynen M, Pinto N. Dimensional changes of the post extraction alveolar ridge, preserved with Leukocyte- and Platelet Rich Fibrin: A clinical pilot study. J Dent. 2016 Sep;52:23-9. doi: 10.1016/j.jdent.2016.06.005. Epub 2016 Jun 20.
- Background: PubMed 29033524Alzahrani AA, Murriky A, Shafik S. Influence of platelet rich fibrin on post-extraction socket healing: A clinical and radiographic study. Saudi Dent J. 2017 Oct;29(4):149-155. doi: 10.1016/j.sdentj.2017.07.003. Epub 2017 Aug 2.
- Background: PubMed 23644909Hauser F, Gaydarov N, Badoud I, Vazquez L, Bernard JP, Ammann P. Clinical and histological evaluation of postextraction platelet-rich fibrin socket filling: a prospective randomized controlled study. Implant Dent. 2013 Jun;22(3):295-303. doi: 10.1097/ID.0b013e3182906eb3.
- The link contains forms used in the clinical trial on Platelet-Rich Fibrin (PRF) for alveolar preservation, including informed consent templates, clinical evaluation forms, radiographic analysis templates, and randomization records. Due to patient privaLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Radiographic CBCT images (de-identified) Clinical measurements (bone height, depth, and quality) Demographic information (age, sex, general health status) Outcome measures (PRF effectiveness in alveolar preservation) Access Criteria: Available to qualified researchers upon request Requires a formal data access request and institutional agreement Compliance with ethical and privacy regulations Time Frame: Available upon study publication Accessible for at least five years post-publication Storage: Data will be stored in a secure university repository and potentially in public research databases. This plan ensures transparency, collaboration, and compliance with ICMJE guidelines for clinical research.
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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.
ROCIO MAGDALENA MOLINA BARAHONA, Doctor of Dental Surgery (DDS) principal investigator
Universidad Católica de Cuenca
RENATA A AVECILLAS RODAS, Doctor of Dental Surgery (DDS) study chair
Universidad Católica de Cuenca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Platelet-Rich Fibrin (PRF) Application for Alveolar Preservation in people with Alveolar Bone Resorption and Preserving the Alveolar Ridge, run by Universidad Católica de Cuenca at 1 site in Ecuador.
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 6 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 28 Mar 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 Ecuador. 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?
Change in alveolar bone height (mm) at 30 and 120 days post-extraction as measured by CBCT (time frame: Baseline (immediately post-extraction), 30 days, and 120 days post-extraction.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06900036, which also lists 4 linked publications.
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 28 Mar 2025.