Efficacy of the Entire Papilla Preservation Technique With and Without the Use of L-PRF as a Regenerative Material for the Treatment of Infrabony Defects

Summary

The goal of this clinical trial is to evaluate the efficacy of using L-PRF (leukocyte and platelet rich fibrin clot) as an autologous filling material in conjunction with the EPP (entire papilla preservation) technique for the treatment of interproximal intraosseous periodontal defects, compared to the same technique without L-PRF regarding clinical periodontal parameters and obtained radiographic parameters. It will also report possible postoperative complications and evaluate postoperative sensitivity. The main questions it aims to answer is:

• What is the effectiveness of LPR-F in conjunction with a complete papilla preservation (EPP) technique for the treatment of intrabony periodontal defects in CESA (health care center) patients in terms of clinical and radiographic periodontal parameters compared to the use of the same technique without L-PRF?

A non-randomized controlled clinical trial will be conducted on patients at CESA of the Universidad de los Andes. In 30 patients, 30 periodontal defects associated with a pocket with probing depths equal to or greater than 6 mm will be treated using the complete papilla preservation technique, either with L-PRF filling or without any filling material, assigned randomly to each intervention (15 participants in each group). Researchers will evaluate clinical and radiographic parameters at baseline and 6 months post-surgery. Patients will report their level of pain 24 hours and 7 days after surgery.

Conditions

• Periodontal Regeneration
• Minimally Invasive Surgical Technique
• Platelet Rich Fibrin
• Microsurgery
• Periodontal Intrabony Defect
• Periodontal Disease

Interventions

PROCEDURE

Periodontal Regeneration, clinical and radiographic results, modified minimal invasive surgery

The Entire Papilla Preservation Technique (EPP) is a minimally invasive surgical approach for the treatment of intraosseous defects allowing access to the defect maintaining the integrity of the interproximal papilla. Studies have evaluated its efficacy for the regeneration of intraosseous periodontal defects with or without the use of regenerative biomaterials to fill the defect.

PROCEDURE

REGEND001 Autologous Therapy Product

L-PRF is an autologous concentrate of platelet- and leukocyte-rich fibrin derived from blood, which through a centrifugation process allows to stimulate, improve and accelerate healing. The growth factors in the concentrates, together with pro-inflammatory and anti-inflammatory molecules, actively participate in the stimulation of the processes associated with tissue and bone repair and regeneration. Due to its high content of fibrin, platelets, leukocytes, monocytes and stem cells, L-PRF acts in immune regulation by controlling inflammation, with a continuous release of growth factors and presents an analgesic effect, which gives greater postoperative comfort to the patient. In addition, being an autologous product, it greatly reduces the risk of infection or rejection by the patient. Due to its beneficial biological effects, low costs and ease of preparation its use as a filling material in intraosseous defects will be evaluated.

Sponsors & Collaborators

• Universidad de los Andes, Chile

  lead OTHER

Principal Investigators

• Andreas G Anwandter, DDS · Universidad de Los Andes

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-08-27

Primary Completion

2026-06-30

Completion

2026-06-30

Countries

• Chile

Study Locations