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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness and comfort of two gum disease treatments. One group will undergo a procedure called open flap debridement (OFD), which cleans the gums. The other group will receive the same procedure with an additional step using leukocyte and platelet-rich fibrin (L-PRF), which may aid healing. The trial seeks participants who require gum surgery on both sides of their mouth and smoke no more than 10 cigarettes a day. As an unphased trial, it provides patients the opportunity to contribute to the understanding and improvement of gum disease treatments.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that leukocyte and platelet-rich fibrin (L-PRF) is generally safe and well-tolerated for treating gum problems. Studies have found it effective for managing gingival recession, where gums recede and expose more of the tooth. People who have used L-PRF in various treatments have experienced positive results without major safety issues.

One study examined the use of L-PRF with antibiotics to improve dental health and found it effective. This suggests that L-PRF can be safe and helpful in other dental procedures as well.

Overall, L-PRF has been successfully used in different treatments, demonstrating a good safety record and positive effects on gum and dental health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Leukocyte Platelet-rich fibrin (L-PRF) for gum disease because it offers a novel approach compared to standard treatments like scaling and root planing or traditional open flap debridement. Unlike these standard methods, L-PRF utilizes the body's own platelets to promote healing and tissue regeneration, potentially leading to faster recovery times and better outcomes. This method could enhance the effects of existing surgical procedures by boosting the body's natural healing processes, making it a promising addition to periodontal care.

What evidence suggests that this trial's treatments could be effective for gum disease?

This trial will compare two treatment approaches for gum disease. One group will receive open flap debridement (OFD) alone, while another group will receive OFD combined with leukocyte and platelet-rich fibrin (L-PRF). Research has shown that L-PRF can help with gum disease by improving wound healing, reducing pain, fighting bacteria, and aiding in the rebuilding of bone and tissue. These findings suggest that L-PRF could be a useful addition to gum disease treatment. ^{2 6 7 8 9}

Who Is on the Research Team?

Charles Powell, DDS, MS

Principal Investigator

The University of Texas Health Science Center at San Antonio

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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]

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 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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5248642/

Regenerative potential of leucocyte‐ and platelet‐rich fibrin ... The outcomes showed a favourable effect of L‐PRF in all clinical parameters measured, or an improvement of the outcomes in studies where L‐PRF was combined with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11392565/

From Healing to Regeneration: A Comprehensive Review ... The study's results indicated that PRF treatment resulted in significantly better wound healing outcomes, as evidenced by lower pain scores, ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2212426825001721

Dual-action platelet-rich fibrin in periodontal therapy ... In the SRP ± i-PRF group, BOP decreased from 58.3 % to 41.7 %, while in the Metronidazole PRF group, it reduced from 66.7 % to 33.3 % at the 3-month review. The ...

4. nature.com nature.com/articles/s41598-019-44755-6

Antimicrobial capacity of Leucocyte-and Platelet Rich ... The aim of this study was to evaluate the antibacterial properties of the L-PRF membrane and L-PRF exudate against the main periopathogens cultured on agar ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/cid.13208

Efficacy of the application of leukocyte and platelet‐rich ... Leukocyte and platelet-rich fibrin (L-PRF) has been showing to potentially promote bone and tissue regeneration during wound healing. Therefore, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9485915/

Comparative Evaluation of Clinical Efficacy of Leukocyte ... Based on the findings of this study, both L-PRF and A-PRF may be suggested as viable treatment options for the management of gingival recession in maxilla.

7. nature.com nature.com/articles/s41598-020-59319-2

The Effects of Leukocyte-Platelet Rich Fibrin (L-PRF) on ... L-PRF can increase SC proliferation, neurotrophic factors secretion, and suppress SC PG-LPS-induced inflammatory responses in vitro.

8. bmcoralhealth.biomedcentral.com bmcoralhealth.biomedcentral.com/articles/10.1186/s12903-024-05254-x

Evaluation of leukocyte-platelet rich fibrin as an antibiotic slow ... This study aimed to evaluate the efficacy of L-PRF as a locally sustained released device for metronidazole antimicrobial. Methods. Twenty-four ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT05043935

Study Details | NCT05043935 | The Effect of Leukocyte and ... Leukocyte and platelet-rich fibrin (L-PRF) has been used extensively in the treatment of intrabony defects and achieved excellent results. It acts as an ...