Concentrated Platelet Rich Fibrin (C-PRF) as Adjunct to Non-surgical Periodontal Therapy

Concentrated Platelet Rich Fibrin (C-PRF) as Adjunct to Non-surgical Periodontal Therapy- a Split Mouth Randomized Clinical Trail

The current study is a prospective randomised split mouth study to evaluate the effect of concentrated Platelet Rich Fibrin as an adjunct to the scaling and root planing

Study Overview

• Status: Completed
• Conditions: Periodontal Pocket
• Intervention / Treatment: Biological: C-PRF

Detailed Description

Twelve healthy individuals satisfying the inclusion and exclusion criteria were recruited for the study. A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. All patients were informed about the nature of the study, procedure involved, potential benefits and risks associated with procedure and written informed consent were obtained from all patients.

All the patients underwent scaling and root planing. As it is split mouth study design the test site is treated with Concentrated platelet rich fibrin( C-PRF) and the contralateral site is not treated with C-PRF. Periodotal pack was placed and patient was recalled after 6 weeks for the follow up.

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 562157
      • Krishnadevaraya college of dental sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Patient age ranging from 18-45 years
2. Contralateral sites with probing depth 5mm-7mm associated with premolar and molar teeth with no furcation involvement
3. No systemic disease
4. Not under any medication which effect the outcome of periodontal therapy

Exclusion Criteria:

1. History of any periodontal therapy within past 6 months
2. Pregnant and lactating mothers
3. Smokers smoking >10 cigarettes per day
4. Patients with blood disorders or platelet count less than 50000 cells/ µL
5. Patients with known systemic disease
6. Non-compliant patients

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probing sites with SPR and C-PRF application; The test group received the C-PRF as adjunct to sacling and root planing	Biological: C-PRF; thorough scaling and root planing is performed followed by withdraw of 5ml of blood from antecubital vein of patient with consent . Following C-PRF protocol of 3000rpm for 8 min centrifugation is performed. 1ml of plasma is drawn from the test tube just above the red blood cell layer and allowed to clot and the formed clot is placed in the periodontal pocket after scaling and root planing; Other Names: Concentrated platelet rich fibrin
No Intervention: Probing sites with SPR alone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Probing pocket Depth	measured using a UNC-15 probe (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA)	6 weeks
Relative attachment level	measured by placing the acrylic stent on the selected teeth using UNC-15 probe (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA)	6 weeks

Collaborators and Investigators

• Sponsor: Krishnadevaraya College of Dental Sciences & Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): March 23, 2023
• Study Completion (Actual): March 29, 2023

Study Registration Dates

• First Submitted: July 14, 2023
• First Submitted That Met QC Criteria: July 14, 2023
• First Posted (Actual): July 24, 2023

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis; Periodontal Pocket
• Other Study ID Numbers: KCDSHEC/IP/2023/P7

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No