Actively Recruiting
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: A Randomized Controlled Clinical Trial
Led by Universidad de los Andes, Chile · Updated on 2024-11-25
30
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the use of L-PRF (leukocyte and platelet rich fibrin) combined with the Entire Papilla Preservation (EPP) surgical technique for treating interproximal intraosseous periodontal defects. The study compares outcomes of the EPP technique with and without L-PRF in patients with periodontitis, focusing on clinical and radiographic periodontal parameters. It also assesses postoperative complications and sensitivity, addressing the need for minimally invasive and affordable treatments for severe periodontal disease. The trial involves 30 patients with periodontal defects treated using the EPP technique. Half of the patients will have their defects filled with L-PRF, an autologous blood-derived material that may aid healing and reduce inflammation, while the other half will receive the procedure without any filling material. Both groups will be evaluated at the start and 6 months after surgery. The L-PRF is prepared through centrifugation of the patient's own blood and applied as a filling to the defect site. Participants will undergo clinical evaluations including plaque index, bleeding on probing, probing depth, attachment levels, gingival margin position, and papilla measurements before surgery and 6 months later. Radiographic assessments using CBCT scans will measure defect size and healing. Patients will report pain levels 24 hours and 7 days post-surgery. Researchers will monitor healing progress, effectiveness of the procedure, and any complications over the 6-month follow-up period.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients diagnosed with periodontal disease showing loss of interproximal clinical attachment in two non-adjacent teeth or clinical attachment loss of 3 mm or more with probing depth over 3 mm in two or more teeth
- Residual probing depths of 6 mm or greater after non-surgical periodontal therapy re-evaluation at 6 weeks
- Presence of interproximal intrabony periodontal defects with at least two walls, depth of 3 mm or more, and angulation of 40 degrees or less on periapical radiograph
You will not qualify if you...
- Patients with uncontrolled diseases such as diabetes or hypertension
- Patients taking medications that interfere with healing, such as bisphosphonates
- Patients with diseases affecting bone metabolism like osteoporosis
- Pregnant or breastfeeding women
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single surgical procedure with follow-up until 6 months post-surgery
Participants undergo a minimally invasive surgical procedure called the Entire Papilla Preservation Technique to treat infrabony periodontal defects, with or without the use of L-PRF as a regenerative filling material.
1 surgery visit and follow-up visits up to 6 months post-surgery
Duration - 6 months
Participants are monitored through clinical and radiographic evaluations to assess healing and treatment outcomes, including pain assessment shortly after surgery and evaluations at 6 months post-treatment.
Follow-up visits at 24 hours, 7 days, and 6 months after surgery
Trial Site Locations
Total: 1 location
1
CESA (centro de salud de la clínica odontológica de la Universidad de los Andes)
Santiago, San Bernardo, Chile, 8050000
Actively Recruiting
Research Team
A
Andreas G Anwandter, DDS
A
Antonio Sanz, DDS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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