Healing WoundNCT07023757
Effect of Age on PRF Quality; Assessed by Evaluating Healing Outcomes of ARP
A study testing Socket preservation in people with Healing Wound, run by University of Michigan at 1 site in United States.
Trial summary
This study will examine whether using PRF and your age are going to affect the healing and regeneration benefits gained from PRF. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Healing Wound
- What is being tested?
- Socket preservation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2025to 1 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range: 20 to 80 years.
- Patients must require tooth extraction (molars) as a result of caries, periodontal disease, tooth fracture or deemed unrestorable.
- Non-infected sockets with intact buccal bone (≥1.5 mm in thickness measured through calipers)
- Patients interested in implant placement following tooth extraction.
Who cannot join
- Allergies or hypersensitivities to study related medications.
- Hematologic disorders/blood dyscrasias.
- Active infectious diseases of any kind.
- Liver or kidney dysfunction/failure.
- Uncontrolled diabetes (HbA1c > 8).
- Active cancer treatment - such as active chemotherapy or radiation therapy.
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- Taking medications that will affect their bone healing (for example, bisphosphonates, Long-term NSAIDs use, Steroid).
- Metabolic bone diseases that affect bone healing such as osteoporosis.
- Pregnant or lactating women (self-reported).
- Smoke 10 or more cigarettes per day (self-reported).
- Poor oral hygiene.
- Systemic diseases that compromise the immune system
- Anti-coagulant therapy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of Michigan School of Dentistry
Ann Arbor, Michigan, 48109
About this study
This study will examine whether using PRF and your age are going to affect the healing and regeneration benefits gained from PRF.
Read the detailed description
Platelet-rich fibrin (PRF) is commonly used to enhance gum tissue healing and reducing pain after tooth extraction and before placing a dental implant. 44 patients requiring a tooth extraction will be recruited and randomized to receive a collagen plug with or without platelet-rich fibrin.
- Conditions
- Healing Wound
- Being tested
- Socket preservation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Socket preservationProcedure or surgery
After tooth extraction, the extraction socket will be filled with a collagen plug in one group or a platelet-rich fibrin plug in the other.
| Study group | Role | What they receive |
|---|---|---|
| Platelet-rich fibrin group. | Active comparator | Following extraction, a Platelet-rich fibrin plug will be placed in the extraction socket and covered with a collagen plug. Receives: Procedure: Socket preservation |
| Collagen plug only | Sham comparator | Collagen plug only Receives: Procedure: Socket preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alveolar ridge dimension changes
Digitally measured alveolar ridge dimension changes in mm^2 using cone-beam computed tomography
Measured: 4 months
Soft tissue dimension changes
Digitally measured soft tissue changes in mm^2 using intraoral scans
Measured: 4 months
Secondary outcomes (4)
Histological bone density.
Histomorphometry.
Measured: 4 months
Presence of bone turnover proteins.
Immunohistochemistry.
Measured: 4 months
Amount of growth factors
Growth factors (PDGF, VEGF and TGF b1) from PRF obtained from drawn blood
Measured: At baseline surgery
Wound healing index
Wound healing index (WHI) according to the following scheme: Score "1" for uneventful wound healing with no gingival edema, erythema, suppuration, discomfort or barrier exposure; Score "2" for uneventful wound healing with slight gingival edema, erythema, or discomfort but no suppuration; Score "3" for poor wound healing with significant gingival edema, erythema, discomfort, loss of barrier or any suppuration.
Measured: 1 week, 2 weeks, 4 weeks, and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start12 Jun 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healing WoundStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Saleh, University of Michigan
- Investigators
- Muhammad Saleh, BDS, MSD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023757
- Sponsor's protocol ID
- HUM00264197
- Status last verified
- Jul 2026
- First submitted
- 4 Jun 2025
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Age on PRF Quality; Assessed by Evaluating Healing Outcomes of ARP
- ClinicalTrials.gov ID
- NCT07023757
- Acronym / sponsor ID
- HUM00264197
- Conditions
- Healing Wound
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 17 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.
This study will examine whether using PRF and your age are going to affect the healing and regeneration benefits gained from PRF.
Detailed description
Platelet-rich fibrin (PRF) is commonly used to enhance gum tissue healing and reducing pain after tooth extraction and before placing a dental implant. 44 patients requiring a tooth extraction will be recruited and randomized to receive a collagen plug with or without platelet-rich fibrin.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Platelet-rich fibrin group. | Active comparator | Procedure: Socket preservationFollowing extraction, a Platelet-rich fibrin plug will be placed in the extraction socket and covered with a collagen plug. |
| Collagen plug only | Sham comparator | Procedure: Socket preservationCollagen plug only |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age range: 20 to 80 years.
- Patients must require tooth extraction (molars) as a result of caries, periodontal disease, tooth fracture or deemed unrestorable.
- Non-infected sockets with intact buccal bone (≥1.5 mm in thickness measured through calipers)
- Patients interested in implant placement following tooth extraction.
Key exclusion criteria (13 listed)
- Allergies or hypersensitivities to study related medications.
- Hematologic disorders/blood dyscrasias.
- Active infectious diseases of any kind.
- Liver or kidney dysfunction/failure.
- Uncontrolled diabetes (HbA1c > 8).
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 |
|---|---|---|
| Socket preservationAfter tooth extraction, the extraction socket will be filled with a collagen plug in one group or a platelet-rich fibrin plug in the other. | Procedure or surgery | Collagen plug only, Platelet-rich fibrin group. |
Primary outcome
Alveolar ridge dimension changes
Time frame: 4 months
Digitally measured alveolar ridge dimension changes in mm^2 using cone-beam computed tomography
Soft tissue dimension changes
Time frame: 4 months
Digitally measured soft tissue changes in mm^2 using intraoral scans
4 secondary outcomes
Histological bone density.
Time frame: 4 months
Presence of bone turnover proteins.
Time frame: 4 months
Amount of growth factors
Time frame: At baseline surgery
Wound healing index
Time frame: 1 week, 2 weeks, 4 weeks, and 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Muhammad Saleh, BDS, MSD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Socket preservation in people with Healing Wound, run by University of Michigan at 1 site in United States.
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 4 inclusion and 13 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: enrolling by invitation, as of the sponsor's last update on 15 Jul 2026. 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 United States. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
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?
Alveolar ridge dimension changes (time frame: 4 months). The study lists 2 primary outcomes in all. 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 Jul 2026.