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

NCT06694168 | Recruiting

• 1 other identifier: CEC2024045
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Periodontitis; Guided Tissue Regeneration; Microsurgery; Bone Regeneration; Treatment Outcome; Intrabony defect; minimally invasive surgical technique; Entire papilla preservation

Outcome Measures

Primary Outcomes (9)

• Probing depth

  Distance between the gingival margin and the bottom of the periodontal sulcus or pocket.

  From enrollment to the end of treatment 6 months postoperatively

• Clinical attachment level

  Distance between the cemento-enamel junction (CEJ) or a stable reference to the bottom of the periodontal pocket.

  From enrollment to the end of treatment 6 months postoperatively

• 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.

  From enrollment to the end of treatment 6 months postoperatively

• Distance from contact point to tip of papilla (PP)

  Distance between the interproximal contact point and the tip of the interproximal papilla

  From enrollment to the end of treatment 6 months postoperatively

• Keratinized Gingiva Width

  Distance between the tip of the interproximal papilla and the mucogingival line.

  From enrollment to the end of treatment 6 months postoperatively

• Infrabony component of the defect (INFRA)

  Determined by the subtraction between distance from CEJ to the bottom of the defect (BD) minus the distance from CEJ to the tip of the interproximal crest (IC)

  From enrollment to the end of treatment 6 months postoperatively

• Defect filling percentage after surgery (%DF)

  Measured by subtraction between distance from CEJ to the bottom of the defect (BD) minus the distance from CEJ to the tip of the interproximal crest (IC), allowing the calculation of percentage defect filling (%DF) after surgery

  From enrollment to the end of treatment 6 months postoperatively

• Mesiodistal width (M-D) of the defect

  Distance between the mesial and distal wall of the osseous defect

  From enrollment to the end of treatment 6 months postoperatively

• Buccal-palatal/lingual width (B-P/L) of the defect

  Distance between the bucal and palatal/lingual wall of the osseous defect in mm.

  From enrollment to the end of treatment 6 months postoperatively

Secondary Outcomes (1)

• Patient reported outcome: Pain

  24 hours after surgery and one week after surgery

Study Arms (2)

EPP with L-PRF as a filling material

EXPERIMENTAL

This group will have the infrabony defect treated with the use of an EPP minimally invasive technique and the defect will be filled with L-PRF.

Procedure: Periodontal Regeneration, clinical and radiographic results, modified minimal invasive surgery; Procedure: REGEND001 Autologous Therapy Product

EPP with no defect filling material

ACTIVE COMPARATOR

This group will have the infrabony defect treated with the use of an EPP minimally invasive technique, but the defect will not be filled with L-PRF.

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

Interventions

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

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.

EPP with L-PRF as a filling material; EPP with no defect filling material

REGEND001 Autologous Therapy Product PROCEDURE

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.

EPP with L-PRF as a filling material

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de los Andes, Chile: lead

Study Sites (1)

CESA (centro de salud de la clínica odontológica de la Universidad de los Andes)

Santiago, San Bernardo, 8050000, Chile

RECRUITING

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

• Andreas G Anwandter, DDS

  Universidad de Los Andes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Andreas G Anwandter, DDS

CONTACT

+56225891100; aanwandter@miuandes.cl

Antonio Sanz, DDS

CONTACT

+56225891173; asanz@clinicasanz.cl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: To calculate the sample size, statistically significant EVA values were taken from a previous series of cases in the same line of research. The values were analyzed using STATA software, resulting in an N of 26 patients (26 defects). Finally, a final N of 30 defects to be treated was established (1 defect per patient), overestimating the initial N in case of possible losses during the follow-up period. If there is more than one site per patient that needs to be treated, it will be decided randomly which site will be included in the study, treating all sites with the same technique. The sample was randomized using the digital STATA software, separating the sample into sites to be treated using the EPP technique with defect filling using LPRF (15 defects) and sites to be treated with the same technique but without LPRF (15 defects).

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 19, 2024
• Study Start: August 27, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: November 25, 2024

Record last verified: 2024-09

Locations

CL (1)