L-PRF for Gum Disease

Overseen By Charles Powell, DDS, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center at San Antonio

Disqualifiers: Mental incompetence, Pregnancy, Smoking >10, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 week

32 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment L-PRF for gum disease?

Research shows that L-PRF, which is rich in blood cells and growth factors, helps in tissue regeneration and wound healing, especially in the mouth. Studies have found it effective in improving outcomes in gum surgeries and treating bone defects in the gums. ^{1 2 3 4 5}

Is L-PRF safe for use in humans?

L-PRF, used in various dental and surgical procedures, is generally considered safe and helps in tissue healing and regeneration. Studies show it supports early healing and stable tissue remodeling, with no significant safety concerns reported. ^{2 4 6 7 8}

How is the L-PRF treatment for gum disease different from other treatments?

L-PRF is unique because it uses a patient's own blood to create a fibrin membrane rich in white blood cells and platelets, which helps promote tissue healing and has antimicrobial properties against certain bacteria that cause gum disease. ^{2 7 9 10 11}

What is the purpose of this trial?

The study will compare the clinical outcomes of the two procedures, open flap debridement (OFD) compared to open flap debridement with leukocyte and platelet-rich fibrin (L-PFR) as well as differences in patient postoperative pain perception.

Research Team

Charles Powell, DDS, MS

Principal Investigator

The University of Texas Health Science Center at San Antonio

Eligibility Criteria

This trial is for adults aged 18-89 with gum disease needing periodontal surgery, who smoke less than 10 cigarettes a day. It's not for pregnant women or those planning to become pregnant, heavy smokers (>10 cigarettes/day), people unable to follow the study schedule, prisoners, or mentally incompetent individuals.

Inclusion Criteria

I need gum surgery on both sides of my mouth.

I am a woman who is not pregnant and can have children.

I am a nonsmoker, former smoker, or smoke less than 10 cigarettes a day.

Exclusion Criteria

Pregnant women or women intending to become pregnant during the study period

Patients who disclose that they will not be able to cooperate with the follow-up schedule

Patients who are mentally incompetent, prisoners, or pregnant (as obtained via chart review or self-report)

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo periodontal surgery with either OFD or OFD + L-PRF

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Multiple visits (in-person)

Treatment Details

Interventions

• Leukocyte Platelet-rich fibrin

Trial Overview The study tests two types of gum surgery: standard open flap debridement (OFD) and OFD with an added material called leukocyte and platelet-rich fibrin (L-PRF). The goal is to see which method gives better results and how they affect patient pain after surgery.

Participant Groups

Group I: Group OFD Experimental Treatment 1 Intervention

Open flap debridement (OFD) is one periodontal surgical procedure that is used to improve periodontal health by providing access to the tooth roots and alveolar bone.

Group II: Group OFD + L-PRF Active Control 1 Intervention

Open flap debridement (OFD) with L-PRF is used during periodontal surgical procedure that is used to improve periodontal health by providing access to the tooth roots and alveolar bone.

Leukocyte Platelet-rich fibrin is already approved in United States, European Union for the following indications:

Approved in United States as L-PRF for:

• Periodontal regeneration
• Bone grafting
• Sinus lift procedures
• Socket preservation

Approved in European Union as L-PRF for:

• Periodontal regeneration
• Bone grafting
• Sinus lift procedures
• Socket preservation
• Guided bone and tissue regeneration

Who Is Running the Clinical Trial?

The University of Texas Health Science Center at San Antonio

Lead Sponsor

Trials

486

Recruited

92,500+

Findings from Research

Leucocyte- and platelet-rich fibrin (L-PRF) significantly improves periodontal healing outcomes, showing notable reductions in pocket depth (1.1 mm) and gains in clinical attachment level (1.2 mm) and bone fill (1.7 mm) compared to open flap debridement in intra-bony defects.

In furcation defects, L-PRF also demonstrated significant improvements in pocket depth (1.9 mm), clinical attachment level (1.3 mm), and bone fill (1.5 mm) compared to open flap debridement, while showing similar outcomes to connective tissue grafts, indicating its effectiveness in enhancing periodontal surgery results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Regenerative potential of leucocyte- and platelet-rich fibrin. Part A: intra-bony defects, furcation defects and periodontal plastic surgery. A systematic review and meta-analysis. Castro, AB., Meschi, N., Temmerman, A., et al.[2022]

Leucocyte- and platelet-rich fibrin (L-PRF) significantly influences the expression of 33 key genes in human gingival fibroblasts, which are crucial for wound healing, indicating its potential to enhance tissue regeneration in surgical applications.

The effects of L-PRF on fibroblast gene expression are both time- and dose-dependent, and they operate through specific signaling pathways, suggesting a well-defined mechanism of action that could improve healing outcomes in oral surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leucocyte- and platelet-rich fibrin regulates expression of genes related to early wound healing in human gingival fibroblasts. Bi, J., Intriago, MFB., Koivisto, L., et al.[2021]

In a study involving 30 non-smoking patients with infrabony pockets, covering leukocyte platelet-rich fibrin (L-PRF) with collagen membranes (CM) resulted in a significantly better defect base fill compared to open flap debridement (OFD) and uncovered L-PRF after 6 months, indicating a mechanical protective effect of the CM.

Despite the improved defect fill, the release profiles of growth factors PDGF-BB and VEGF did not show significant differences between the treatment groups, suggesting that the enhanced healing observed may not be due to increased growth factor release from L-PRF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adjunctive effect of collagen membrane coverage to L-PRF in the treatment of periodontal intrabony defects: a randomized controlled clinical trial with biochemical assessment. Mubarak, R., Adel-Khattab, D., Abdel-Ghaffar, KA., et al.[2023]

In a study involving 16 patients with generalized aggressive periodontitis, platelet-rich fibrin (PRF) demonstrated comparable regenerative effects to collagen membrane (CM) for treating intrabony periodontal defects, with both treatments significantly improving clinical outcomes after 6 months.

PRF showed a statistically significant improvement in the position of the gingival margin compared to CM, suggesting it may offer additional benefits in gum health during periodontal regeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Platelet-Rich Fibrin for the Treatment of Intrabony Periodontal Defects in Patients with Generalized Aggressive Periodontitis: A Randomized Controlled Clinical Study. Aggour, RL., Abd El-Hady, HMG.[2019]

The use of leukocyte-platelet-rich fibrin (L-PRF) in treating a combined endo-periodontal lesion showed significant improvement in periodontal pocket depth, reducing from 11 mm and 14 mm to 3 mm and 5 mm after treatment, despite no observable bone regeneration on imaging.

This case suggests that L-PRF may enhance the prognosis of teeth with poor outcomes due to endo-periodontal lesions, offering a less invasive alternative to extraction and implants, although more clinical trials are needed to confirm its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of endo-periodontal lesion using leukocyte-platelet-rich fibrin. A case report. Betancourt, P., Elgueta, R., Fuentes, R.[2022]

Choukroun's platelet-rich fibrin (PRF) can significantly enhance healing in periodontal surgery when produced using a reproducible protocol that ensures consistent quality and quantity of its components.

Following established tissue-engineering principles in conjunction with classical periodontal concepts when using PRF leads to improved early healing and results in thicker, more stable gingival tissue after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Re: "Clinical evaluation of a modified coronally advanced flap alone or in combination with a platelet-rich fibrin membrane for the treatment of adjacent multiple gingival recessions: a 6-month study". Del Corso, M., Sammartino, G., Dohan Ehrenfest, DM.[2022]

In a study of 13 patients with medication-related osteonecrosis of the jaws (MRONJ), the use of leukocyte- and platelet-rich fibrin (L-PRF) as an adjunct to surgical treatment showed promising results, with complete healing observed in all patients who underwent marginal resection and six out of nine who had sequestrectomy.

L-PRF is highlighted as a beneficial option for enhancing tissue repair in MRONJ treatment due to its autologous nature, ease of application, and cost-effectiveness, making it a valuable addition to surgical interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promising results of surgical management of advanced medication related osteonecrosis of the jaws using adjunctive leukocyte and platelet rich fibrin. Özalp, Ö., Yıldırımyan, N., Öztürk, C., et al.[2022]

Leukocyte- and platelet-rich fibrin (L-PRF) membranes, used after tooth extraction, promote effective healing of both bone and soft tissues, as shown by histological analysis.

In a case study involving a patient who underwent tooth extraction and implant placement after 3 months, L-PRF demonstrated positive outcomes in maintaining bone dimensions and quality, supporting its use in alveolar ridge preservation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postextractive Alveolar Ridge Preservation Using L-PRF: Clinical and Histological Evaluation. Serafini, G., Lollobrigida, M., Fortunato, L., et al.[2020]

Leukocyte platelet-rich fibrin (L-PRF) was effective in promoting deep wound healing in a 48-year-old woman with tongue cancer, leading to complete healing 15 days after treatment, despite a five-week delay in healing due to surgery.

L-PRF may be beneficial for patients with pN0 status (no lymph node involvement) in deep wound healing, but its use is not recommended for patients with pN1 status due to the risk of activating potential tumor cells with the growth factors it contains.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can L-PRF be helpful for delayed deep wound healing after a tracheotomy or lymph node dissection in a pN0 status?: A case report. Fourneau, E., Magremanne, M., Dubron, K.[2023]

The study found that Leucocyte- and Platelet Rich Fibrin (L-PRF) membranes have significant antibacterial properties against periodontal pathogens, particularly showing strong inhibition against P. gingivalis, a key bacteria involved in gum disease.

While L-PRF exudate also inhibited P. gingivalis in a dose-dependent manner, it unexpectedly promoted the growth of A. actinomycetemcomitans in planktonic solutions, highlighting the need for careful consideration of its effects on different bacteria.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Antimicrobial capacity of Leucocyte-and Platelet Rich Fibrin against periodontal pathogens. Castro, AB., Herrero, ER., Slomka, V., et al.[2021]

In a study involving 18 immediate implants, the use of leukocyte-platelet-rich fibrin (L-PRF) during implant placement showed a marginal but statistically significant benefit in hard and soft tissue outcomes compared to implants placed without L-PRF.

However, the overall clinical and radiographic improvements were statistically nonsignificant, suggesting that while L-PRF may offer some advantages, its impact on healing in immediate implant sites is limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of leukocyte-platelet-rich fibrin membrane in immediate postextraction implant placement: A randomized controlled trial. Soni, M., Gugnani, S., Pandit, N., et al.[2023]

References

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

Regenerative potential of leucocyte- and platelet-rich fibrin. Part A: intra-bony defects, furcation defects and periodontal plastic surgery. A systematic review and meta-analysis. [2022]

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

Leucocyte- and platelet-rich fibrin regulates expression of genes related to early wound healing in human gingival fibroblasts. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Adjunctive effect of collagen membrane coverage to L-PRF in the treatment of periodontal intrabony defects: a randomized controlled clinical trial with biochemical assessment. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Platelet-Rich Fibrin for the Treatment of Intrabony Periodontal Defects in Patients with Generalized Aggressive Periodontitis: A Randomized Controlled Clinical Study. [2019]

5. Colombia pubmed.ncbi.nlm.nih.gov

Treatment of endo-periodontal lesion using leukocyte-platelet-rich fibrin. A case report. [2022]

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

Re: "Clinical evaluation of a modified coronally advanced flap alone or in combination with a platelet-rich fibrin membrane for the treatment of adjacent multiple gingival recessions: a 6-month study". [2022]

7. England pubmed.ncbi.nlm.nih.gov

Promising results of surgical management of advanced medication related osteonecrosis of the jaws using adjunctive leukocyte and platelet rich fibrin. [2022]

8. Egypt pubmed.ncbi.nlm.nih.gov

Postextractive Alveolar Ridge Preservation Using L-PRF: Clinical and Histological Evaluation. [2020]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Can L-PRF be helpful for delayed deep wound healing after a tracheotomy or lymph node dissection in a pN0 status?: A case report. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Antimicrobial capacity of Leucocyte-and Platelet Rich Fibrin against periodontal pathogens. [2021]

11. India pubmed.ncbi.nlm.nih.gov

Efficacy of leukocyte-platelet-rich fibrin membrane in immediate postextraction implant placement: A randomized controlled trial. [2023]