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Recruiting NCT06694168

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

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Trial Parameters

Condition Periodontal Regeneration
Sponsor Universidad de los Andes, Chile
Study Type INTERVENTIONAL
Phase N/A
Enrollment 30
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-08-27
Completion 2026-06-30
Interventions
Periodontal Regeneration, clinical and radiographic results, modified minimal invasive surgeryREGEND001 Autologous Therapy Product

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Brief 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.

Eligibility Criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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