Socket PreservationNCT07022860
Study on Platelet-Rich Fibrin for Preserving Jawbone After Tooth Extraction Using CBCT Imaging in Adults
A study testing Platelet-rich fibrin (PRF) in people with Socket Preservation, run by Zahedan University of Medical Sciences at 1 site in Iran.
Trial summary
The goal of this clinical trial is to learn if platelet-rich fibrin (PRF), a substance made from a person's own blood, helps preserve the bone in the jaw after tooth extraction in adults. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Socket Preservation
- What is being tested?
- Platelet-rich fibrin (PRF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteIran
- Study dates
- 21 Sep 2024to 18 Jan 2025
- 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
- Participants were eligible for inclusion if they met the following criteria:
- Age ≥ 18 years
- Smoking fewer than 10 cigarettes per day
- Presence of adequate bony support (≥ 60%)
- Indications for bilateral tooth extraction
- Patients classified as ASA I or II (American Society of Anesthesiologists).
Show all 11Show fewer
- No systemic conditions known to impair healing, including the following:
- Use of bisphosphonates
- Anticoagulant or antiplatelet therapy
- History of head and neck radiotherapy
- Chronic use of NSAIDs or corticosteroids
Who cannot join
- Patients were excluded if they met any of the following conditions:
- ASA classification III or IV
- Pregnancy or lactation
- Presence of active infection at the surgical site or need for medications beyond standard analgesics
- Presence of chronic lesions at the extraction site (patients requiring curettage of the lesion were included; those with acute infection requiring antibiotics were excluded).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Radiographic Assessment of the Effects of Platelet-Rich Fibrin on Socket Preservation: A Case-Control Study
The goal of this clinical trial is to learn if platelet-rich fibrin (PRF), a substance made from a person's own blood, helps preserve the bone in the jaw after tooth extraction in adults. The main questions it aims to answer are:
Does PRF help reduce the loss of bone height after tooth removal? Does PRF improve how much of the socket fills with new bone?
Read more
Researchers will compare extraction sites treated with PRF to untreated sites in the same person to see if PRF helps preserve more bone.
Participants will:
Have two teeth removed on opposite sides of the mouth Receive PRF in one socket, while the other socket is left to heal naturally Undergo 3D X-ray scans (CBCT) right after extraction and again 3 months later
This study will help researchers understand if using PRF alone can improve healing and reduce bone loss after tooth extraction.
- Conditions
- Socket Preservation
- Being tested
- Platelet-rich fibrin (PRF)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Platelet-rich fibrin (PRF)Biological
Platelet-rich fibrin (PRF) is an autologous blood-derived material prepared by centrifuging the participant's venous blood without anticoagulants. The PRF clot is then compressed into a membrane and inserted into the extraction socket. It serves as a scaffold rich in platelets and growth factors to support bone regeneration and healing.
| Study group | Role | What they receive |
|---|---|---|
| Split-Mouth PRF Arm | Experimental | Each participant will have two symmetrical tooth extractions. One socket will be randomly assigned to receive platelet-rich fibrin (PRF), and the contralateral socket will serve as a control, healing naturally without any graft material. This split-mouth design allows each participant to act as their own control. Radiographic assessments using cone-beam computed tomography (CBCT) will be conducted at baseline and 3 months to measure bone height, ridge width, and socket fill. Receives: Biological: Platelet-rich fibrin (PRF) |
| Split-Mouth Control Arm | No intervention | Each participant will have two symmetrical tooth extractions. One socket will be randomly assigned to receive platelet-rich fibrin (PRF), and the contralateral socket will serve as a control, healing naturally without any graft material. This split-mouth design allows each participant to act as their own control. Radiographic assessments using cone-beam computed tomography (CBCT) will be conducted at baseline and 3 months to measure bone height, ridge width, and socket fill. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Vertical Ridge Height from Baseline to 3 Months Post-Extraction as Measured by Cone-Beam Computed Tomography (CBCT)
Vertical ridge height was measured using cone-beam computed tomography (CBCT) at two time points: immediately after tooth extraction (baseline) and at 3 months post-extraction. Measurements were taken from the crest of the alveolar ridge to the apex of the extraction socket on both the buccal and lingual sides. The difference in ridge height between the two time points represents the amount of vertical bone loss. A smaller change indicates better preservation of ridge height. The measurements were performed by a blinded radiologist using standardized 1 mm slice thickness and reference lines drawn from the socket apex to the ridge crest.
Measured: Immediately post-extraction (baseline) and at 3 months post-extraction
Secondary outcomes (2)
Change in Horizontal Ridge Width at 1 mm, 3 mm, and 5 mm Apical to the Crest from Baseline to 3 Months Post-Extraction Measured by CBCT
Horizontal ridge width was measured at 1 mm, 3 mm, and 5 mm below the lingual/palatal crest using cone-beam computed tomography (CBCT). The change in width between baseline and 3 months post-extraction was calculated. Smaller changes indicate better preservation of ridge width. Measurements were made using standardized reference lines and a slice thickness of 1 mm.
Measured: Immediately post-extraction (baseline) and at 3 months post-extraction
Percentage of Socket Fill at 3 Months Post-Extraction as Measured by CBCT
The percentage of socket fill was determined using CBCT imaging at 3 months post-extraction. Socket fill refers to the amount of mineralized bone formation within the extraction site. A higher percentage indicates greater bone regeneration. A blinded radiologist performed all measurements using pre-defined reference points and standardized protocols.
Measured: 3 months post-extraction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start21 Sep 2024
- Primary completion18 Jan 2025
- Study completion18 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Socket PreservationStudies 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
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zahedan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alireza Ranjbaran, Zahedan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07022860
- Sponsor's protocol ID
- IR.ZAUMS.REC.1403.379
- Status last verified
- Jun 2025
- First submitted
- 7 Jun 2025
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual de-identified participant data (IPD), study protocol, statistical analysis plan, informed consent form, and clinical study report will be made available to qualified researchers after study completion and publication of the main article. Access will be granted upon reasonable request through written communication with the corresponding author and will be limited to research purposes. Data will be available for at least five years following publication.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiographic Assessment of the Effects of Platelet-Rich Fibrin on Socket Preservation: A Case-Control Study
- ClinicalTrials.gov ID
- NCT07022860
- Acronym / sponsor ID
- IR.ZAUMS.REC.1403.379
- Conditions
- Socket Preservation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Zahedan University of Medical SciencesUniversity, hospital or other
- Study start
- 21 Sep 2024 (actual)
- Primary completion
- 18 Jan 2025 (actual)
- Study completion
- 18 Jan 2025 (actual)
- First posted
- 15 Jun 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.
The goal of this clinical trial is to learn if platelet-rich fibrin (PRF), a substance made from a person's own blood, helps preserve the bone in the jaw after tooth extraction in adults. The main questions it aims to answer are:
Does PRF help reduce the loss of bone height after tooth removal? Does PRF improve how much of the socket fills with new bone?
Researchers will compare extraction sites treated with PRF to untreated sites in the same person to see if PRF helps preserve more bone.
Participants will:
Have two teeth removed on opposite sides of the mouth Receive PRF in one socket, while the other socket is left to heal naturally Undergo 3D X-ray scans (CBCT) right after extraction and again 3 months later
This study will help researchers understand if using PRF alone can improve healing and reduce bone loss after tooth extraction.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Split-Mouth PRF Arm | Experimental | Biological: Platelet-rich fibrin (PRF)Each participant will have two symmetrical tooth extractions. One socket will be randomly assigned to receive platelet-rich fibrin (PRF), and the contralateral socket will serve as a control, healing naturally without any graft material. This split-mouth design allows each participant to act as their own control. Radiographic assessments using cone-beam computed tomography (CBCT) will be conducted at baseline and 3 months to measure bone height, ridge width, and socket fill. |
| Split-Mouth Control Arm | No intervention | –Each participant will have two symmetrical tooth extractions. One socket will be randomly assigned to receive platelet-rich fibrin (PRF), and the contralateral socket will serve as a control, healing naturally without any graft material. This split-mouth design allows each participant to act as their own control. Radiographic assessments using cone-beam computed tomography (CBCT) will be conducted at baseline and 3 months to measure bone height, ridge width, and socket fill. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 18 years
- Smoking fewer than 10 cigarettes per day
- Presence of adequate bony support (≥ 60%)
- Indications for bilateral tooth extraction
- Patients classified as ASA I or II (American Society of Anesthesiologists).
Key exclusion criteria (5 listed)
- ASA classification III or IV
- Pregnancy or lactation
- Presence of active infection at the surgical site or need for medications beyond standard analgesics
- Presence of chronic lesions at the extraction site (patients requiring curettage of the lesion were included; those with acute infection requiring antibiotics were excluded).
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)Platelet-rich fibrin (PRF) is an autologous blood-derived material prepared by centrifuging the participant's venous blood without anticoagulants. The PRF clot is then compressed into a membrane and inserted into the extraction socket. It serves as a scaffold rich in platelets and growth factors to support bone regeneration and healing. | Biological | Split-Mouth PRF Arm |
Primary outcome
Change in Vertical Ridge Height from Baseline to 3 Months Post-Extraction as Measured by Cone-Beam Computed Tomography (CBCT)
Time frame: Immediately post-extraction (baseline) and at 3 months post-extraction
Vertical ridge height was measured using cone-beam computed tomography (CBCT) at two time points: immediately after tooth extraction (baseline) and at 3 months post-extraction. Measurements were taken from the crest of the alveolar ridge to the apex of the extraction socket on both the buccal and lingual sides. The difference in ridge height between the two time points represents the amount of vertical bone loss. A smaller change indicates better preservation of ridge height. The measurements were performed by a blinded radiologist using standardized 1 mm slice thickness and reference lines drawn from the socket apex to the ridge crest.
2 secondary outcomes
Change in Horizontal Ridge Width at 1 mm, 3 mm, and 5 mm Apical to the Crest from Baseline to 3 Months Post-Extraction Measured by CBCT
Time frame: Immediately post-extraction (baseline) and at 3 months post-extraction
Percentage of Socket Fill at 3 Months Post-Extraction as Measured by CBCT
Time frame: 3 months 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 15 Jun 2025.
- Individual participant dataSharing planned: Yes. Individual de-identified participant data (IPD), study protocol, statistical analysis plan, informed consent form, and clinical study report will be made available to qualified researchers after study completion and publication of the main article. Access will be granted upon reasonable request through written communication with the corresponding author and will be limited to research purposes. Data will be available for at least five years following publication.
Related trials for Socket Preservation
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Biotivity A-C Membrane Socket Preservation Study
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Vallomix Socket Preservation Study
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Bone and Soft Tissue Healing After Socket Preservation With NOVAMag or Permamem Membranes
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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 study testing Platelet-rich fibrin (PRF) in people with Socket Preservation, run by Zahedan University of Medical Sciences at 1 site in Iran.
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 11 inclusion and 5 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 15 Jun 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 Iran. 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 Vertical Ridge Height from Baseline to 3 Months Post-Extraction as Measured by Cone-Beam Computed Tomography (CBCT) (time frame: Immediately post-extraction (baseline) and at 3 months 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 15 Jun 2025.