L-PRF Plus Non Surgical Periodontal Treatment

NCT04520438 | Completed

• 1 other identifier: NSPT + L-PRF
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

Abstract: Background: Leucocyte and Platelet-Rich Fibrin (L-PRF) has shown to promote regenerative processes, even reporting antibacterial effect. The aim of this split-mouth clinical trial was to evaluate the effect of L-PRF as an adjuvant to scaling and root planing (SRP). Methods: 13 patients with chronic periodontitis and at least 1 bilateral periodontal pocket ≥ 6 mm were recruited. The sites were randomly treated with SRP + L-PRF (test group) or SRP alone (control group). The following parameters were evaluated at baseline and 6 weeks, 3 and 6 months after treatment: Probing pocket depth (PPD), clinical attachment level (CAL), bleeding on probing (BOP); gingival recession (GR), and root sensitivity (RS). Additionally, the concentrations of Porphyromona gingivalis (P.g), Aggregatibacter actinomycetemcomitans (A.a), Prevotella intermedia (P.i) and Fusobacterium nucleatum (F.n) in the gingival crevicular fluid (GCF) were evaluated at baseline, 6 weeks and 3 months after treatment.

Conditions

Periodontitis

Keywords

Platelet-Rich Fibrin; Chronic Chronic Periodontitis; Dental Scaling; Root Planing; Gingival Crevicular Fluid; Microbiology

Outcome Measures

Primary Outcomes (3)

• Change from baseline pocket probing depth at 6 weeks

  Change from baseline to 6 weeks of the distance from the gingival margin to the base of the clinical pocket for each site. Unit: millimeters

  6 weeks

• Change from baseline pocket probing depth at 3 months

  Change from baseline to 3 months of the distance from the gingival margin to the base of the clinical pocket for each site. Unit: millimeters

  3 months

• Change from baseline pocket probing depth at 6 months

  Change from baseline to 6 months of the distance from the gingival margin to the base of the clinical pocket for each site. Unit: millimeters

  6 months

Secondary Outcomes (18)

• Change from baseline clinical attachment level at 6 weeks

  6 weeks

• Change from baseline clinical attachment level at 3 months

  3 months

• Change from baseline clinical attachment level at 6 months

  6 months

• Change from baseline gingival recession at 6 weeks

  6 weeks

• Change from baseline gingival recession at 3 months

  3 months

Study Arms (2)

NSPT + L-PRF

EXPERIMENTAL

Scaling and root planing associated to Leucocyte and Platelet rich Fibrin Membrane and irrigation with exudate of L-PRF.

Procedure: Leukocyte and platelet rich fibrin; Procedure: Non-Surgical Periodontal treatment

NSPT alone

OTHER

Only Scaling and root planing

Procedure: Non-Surgical Periodontal treatment

Interventions

Leukocyte and platelet rich fibrin PROCEDURE

L-PRF membrane and irrigation with L-PRF exudate in the same treatment session of NSPT

Also known as: L-PRF

NSPT + L-PRF

Non-Surgical Periodontal treatment PROCEDURE

The control group only received NSPT (scaling and root planing) in one treatment session.

Also known as: Scaling and root planing

NSPT + L-PRF; NSPT alone

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 30 and 70 years old
• diagnosis of chronic periodontitis
• at least one bilateral periodontal pocket ≥ 6 mm
• healthy patients

You may not qualify if:

• inability to comply with the study protocol
• receiving antibiotic therapy or non-steroidal anti-inflammatory drugs during the previous two months or using calcium channel blockers, phenytoin, cyclosporine, or any associated drug that might affect gingival tissue
• periodontal treatment during the previous 12 months
• auto-immune disorders (self-reported)
• requiring antibiotic prophylaxis before periodontal treatment; or requiring non-steroidal anti-inflammatory drugs for postoperative pain management after periodontal treatment
• smokers \>10 cigarettes
• pregnancy/lactation.

Sponsors & Collaborators

• Universidad de los Andes, Chile: lead

Study Sites (1)

Universidad de Los Andes

Santiago, 7550000, Chile

Location

MeSH Terms

Conditions

Periodontitis; Chronic Periodontitis

Interventions

Leukocyte Count; Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Officials

• Catherine Andrade, DDs

  Universidad de Los Andes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Only the clinician who provided the treatment knew the treatment assigned. A different clinician performed all the evaluations.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: A split-mouth, randomized controlled clinical trial enrolling 13 patients (8 males and 5 females, mean age 52.3 ± 9.4 years) was set-up. The periodontal pockets ≥ 6 mm were randomly treated with SRP + L-PRF (test group) or SRP alone (control group)

Study Record Dates

• First Submitted: August 12, 2020
• First Posted: August 20, 2020
• Study Start: October 30, 2019
• Primary Completion: April 30, 2020
• Study Completion: May 30, 2020
• Last Updated: August 26, 2020

Record last verified: 2020-08

Locations

CL (1)