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

Sponsor
Krishnadevaraya College of Dental Sciences & Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05958147
Collaborator
(none)
12
Enrollment
1
Location
2
Arms
1.8
Actual Duration (Months)
6.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Biological: C-PRF
 Phase 1

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 4 weeks for the follow up.

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Concentrated Platelet Rich Fibrin (C-PRF) as Adjunct to Non-surgical Periodontal Therapy- a Split Mouth Randomized Clinical Trail
Actual Study Start Date :
Feb 1, 2023
Actual Primary Completion Date :
Mar 23, 2023
Actual Study Completion Date :
Mar 29, 2023

Arms and Interventions

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

    Outcome Measures

    Primary Outcome Measures

    1. Probing pocket Depth [4 weeks]

      measured using a UNC-15 probe (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA)

    2. Relative attachment level [4 weeks]

      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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Krishnadevaraya college of dental sciences Bangalore Karnataka India 562157

    Sponsors and Collaborators

    • Krishnadevaraya College of Dental Sciences & Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Krishnadevaraya College of Dental Sciences & Hospital
    ClinicalTrials.gov Identifier:
    NCT05958147
    Other Study ID Numbers:
    • KCDSHEC/IP/2023/P7
    First Posted:
    Jul 24, 2023
    Last Update Posted:
    Jul 24, 2023
    Last Verified:
    Jul 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Periodontal Pocket

    Study Results

    No Results Posted as of Jul 24, 2023