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.
Patients diagnosed with periodontal disease (loss of interproximal clinical attachment loss in 2 non-adjacent teeth or clinical attachment loss of ≥3mm associated with a PD >3 mm in two or more teeth) will be included.
After re-evaluation (6 weeks after non-surgical periodontal therapy) presented residual probing depths equal to or greater than 6 mm.
Residual pocket is associated with interproximal intrabony periodontal defects of at least 2 walls, with a depth ≥ 3 mm and an angulation ≤ 40º determined on a periapical radiograph.
Patients with an underlying decompensated pathology such as diabetes and hypertension.
Patients taking medications that interfere with the healing process such as bisphosphonates.
Patients with diseases that alter bone metabolism such as osteoporosis.
Pregnant or breastfeeding women.
Parallel
Periodontal Regeneration, clinical and radiographic results, modified minimal invasive surgery
Procedure/SurgeryThe 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.
REGEND001 Autologous Therapy Product
Procedure/SurgeryL-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.
Probing depth
Distance between the gingival margin and the bottom of the periodontal sulcus or pocket.
Clinical attachment level
Distance between the cemento-enamel junction (CEJ) or a stable reference to the bottom of the periodontal pocket.
Bleeding on probing
It will be evaluated dichotomously in 6 sites per tooth and will be defined as a percentage by dividing the sites that bleed on probing with the total number of sites examined multiplied by 100.
Distance from contact point to tip of papilla (PP)
Distance between the interproximal contact point and the tip of the interproximal papilla
Patient reported outcome: Pain
The intensity of pain (ordinal categorical variable) will be measured after surgical treatment using a visual analogue measurement scale (VAS) that will consist of a measurement 24 hours after surgery by telephone and one week after surgery in the clinical control.
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