Clinical trial NCT06685393: Efficacy of Injectable Platelet-rich Fibrin Versus Platelet-Rich Plasma As Adjunctive to Scaling and Root Planning in Non-surgical Periodontal Therapy of Periodontitis Patients
Official title: Effects of Injectable Platelet-rich Fibrin and Platelet-Rich Plasma in Treatment of Diabetic Patients with Stage Ⅱ Grade C Periodontitis (Clinical and Microbiological Study).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peridontal Disease
Keywords: periodontitis, PRP, I-PRF
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-11-12
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to evaluate the Efficacy of Injectable Platelet-rich Fibrin versus Platelet-Rich Plasma as adjunctive to scaling and root planning in non-surgical periodontal therapy of Periodontitis patients (Randomized controlled clinical trial)

Detailed description: Mechanical Debridement (MD) is the gold standard procedure for managing periodontal diseases and infection control. Currently, a minimally invasive approach involving using of local platelets concentrates in the treatment of periodontitis, Platelets are nonnuclear secretory cells deduced from bone marrow as protein-producing cells. Upon activation, the platelets produce secretory grains and synthesize proteins. Platelets contain a variety of protein molecules ranging from membrane proteins, cytokines, regulatory proteins, and bioactive peptides.

Platelet-rich plasma (PRP) Is a 1st-generation platelet concentrate containing a high attention of platelet but a minimal amount of natural fibrinogen. The α granules release growth factors in 3-5 days of platelet activation, which sustain their stimulation of the proliferative phase for ten days after release.

Platelet-rich fibrin (PRF) is a second-generation platelet concentrate that was introduced by Choukroun et al. in 2001, It is allowed that PRF can improve tissue regeneration due to its effects on vascularization, capturing the circulating stem cells, immune control, and closure of the epithelium, Injectable PRF (I-PRF) is the liquid form of PRF. I-PRF is a bioactive agent attained by low-speed centrifugation, and it can stimulate tissue regeneration. I-PRF at high concentrations may stimulate the secretion of several growth factors and trigger fibroblast migration. I-PRF is generally used in regenerative treatments, but it has good issues.

Platelet concentrates (PCs) are characterized by an increased level of platelets, which are considered cells with a multifunctional role in antimicrobial host defense. First, platelets give a rapid response to microbial colonization of vascular endothelium and are the earliest cells at the affected site. Platelets can incorporate microbes themselves and perform pathogen clearance, killing or damaging microorganisms.

Eligibility criteria: Inclusion Criteria:

* • Participants: Adult healthy individuals between 25-45 years old with no gender predilection diagnosed with periodontitis.

  * Fasting blood sugar (80-100mg/dl): This is the recommended range for non-diabetic patients and is according to the American Diabetes Association.
  * (Hemoglobin A1C (HbA1c) levels recommended by the American Diabetes Association. Patients with an HbA1c level equal to or less than 7% were considered patients with well-controlled DM.
  * Patients with at least two quadrants with pocket depth up to 5 mm.

Exclusion Criteria:

* history of any preceding oral infections or periodontal treatment for at least three months before starting the study.
* Smokers and alcoholic patients
* pregnant, post-menopausal, and lactating women.
* Patients with poor systemic health like uncontrolled diabetes, hypertension, osteoporosis, and collagen disorders are also excluded with
* patients who were on or expected to take antibiotics or anti-inflammatory drugs within the duration of the study.

Primary outcomes:
measure: clinical measurement of plaque index (PI).
timeFrame: 3 months
measure: clinical measurement of sulcular bleeding index (SBI).
timeFrame: 3 months
measure: clinical measurement of Probing depth (PD).
timeFrame: 3 months
measure: clinical measurement of Clinical attachment level (CAL).
timeFrame: 3 months
Secondary outcomes:
measure: MICROBIOLOGICAL PARAMETERS
timeFrame: 3 months
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of Dentistry, Mansoura University
state: Dakahlia, Egypt
Study officials:
affiliation: Mansoura University
name: Elsabbahy Ahmed Mohamed youssef, B.D.S
role: PRINCIPAL_INVESTIGATOR
References: