Platelet Rich Fibrin for Tooth Abscess

(EMS Trial)

Overseen By Michael Skanchy, DMD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Mark Schachman

Disqualifiers: Vertical root fractures, Non-restorable teeth, Class 3 mobility, Pregnant, Smoker, Systematic disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 1 day

20 Participants Needed

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Platelet Rich Fibrin for Tooth Abscess?

Research shows that Platelet Rich Fibrin (PRF) helps in faster wound healing and tissue regeneration when used in oral surgeries, such as tooth extractions and periodontal treatments. This suggests it could be beneficial for treating tooth abscesses by promoting healing and reducing complications. ^{1 2 3 4 5}

Is Platelet Rich Fibrin safe for use in humans?

Research shows that Platelet Rich Fibrin (PRF) is generally safe for use in humans, as it helps with wound healing and reduces side effects after dental procedures like wisdom tooth extractions. ^{2 4 6 7 8}

How does the treatment Platelet Rich Fibrin differ from other treatments for tooth abscess?

Platelet Rich Fibrin (PRF) is unique because it uses components from your own blood, like cells and growth factors, to help heal and regenerate bone and soft tissue. Unlike traditional treatments, PRF can accelerate healing and reduce complications after dental procedures, making it a novel option for managing tooth abscesses. ^{2 4 5 9 10}

What is the purpose of this trial?

Current literature on platelet rich fibrin (PRF) use in apicoectomies, also known as endodontic microsurgery, is sparse. PRF use in oral surgery or periodontal surgery has been more thoroughly researched. Whether it is able to reduce post-op pain or if it improves success rate in endodontic microsurgery is not well known. It is also not well known if it will be able to increase the rate of healing. This study will evaluate the success of endodontic microsurgery with and without PRF.

Research Team

Mark Schachman, DMD

Principal Investigator

Eligibility Criteria

This trial is for individuals with conditions like tooth abscess, apical periodontitis, or general periodontitis. Specific eligibility criteria are not provided, so it's best to contact the study organizers for detailed requirements.

Inclusion Criteria

I have front teeth or premolars that had root canal treatment fail with a visible issue on an X-ray.

Exclusion Criteria

My teeth cannot be fixed.

Pregnant

Smoker

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo endodontic microsurgery with or without Platelet-Rich Fibrin (PRF)

1 day

1 visit (in-person)

Follow-up

Participants are monitored for healing outcomes through follow-up exams, CBCT imaging, and pain response tracking

18 months

Multiple visits (in-person) at 6, 12, and 18 months

Treatment Details

Interventions

• Platelet Rich Fibrin

Trial Overview The trial is testing the use of Platelet Rich Fibrin (PRF) in endodontic microsurgery to see if it reduces post-op pain, improves success rates and increases healing speed compared to standard treatment without PRF.

Participant Groups

Group I: Microsurgery with Platelet Rich Fibrin Experimental Treatment 1 Intervention

Patents will have a blood draw completed so that PRF can be made. Endodontic microsurgery will then be completed. Prior to closing the flap, PRF will be placed in the osteotomy.

Group II: Microsurgery Alone Active Control 1 Intervention

Endodontic microsurgery will be completed without PRF. The osteotomy will remain empty as per standard procedure.

Who Is Running the Clinical Trial?

Mark Schachman

Lead Sponsor

Trials

1

Recruited

20+

References

1. India pubmed.ncbi.nlm.nih.gov

Role of plasma-rich fibrin in oral surgery. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Local Application of Platelet-Rich Fibrin During Lower Third Molar Extraction Improves Treatment Outcomes. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Second-generation Platelet Concentrate (Platelet-rich Fibrin) as a Scaffold in Regenerative Endodontics: A Case Series. [2022]

4. Saudi Arabia pubmed.ncbi.nlm.nih.gov

The effects of platelet-rich fibrin on post-surgical complications following removal of impacted wisdom teeth: A pilot study. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Use of Platelet-Rich Fibrin in the Treatment of Periodontal Intrabony Defects: A Systematic Review and Meta-Analysis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Effect of Platelet-rich Fibrin on Odontoblastic Differentiation in Human Dental Pulp Cells Exposed to Lipopolysaccharide. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Platelet-rich fibrin/aspirin complex promotes alveolar bone regeneration in periodontal defect in rats. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Platelet-Rich Fibrin in Third Molar Surgery: Systematic Review and Meta-Analysis Protocol. [2023]

9. India pubmed.ncbi.nlm.nih.gov

Bone Regeneration in an Extreme Dental Clinical Condition. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Advanced platelet-rich fibrin and freeze-dried bone allograft for ridge preservation: A randomized controlled clinical trial. [2020]