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

Primary Purpose

Periodontal Pocket

Status

Completed

Phase

Phase 1

Locations

India

Study Type

Interventional

Intervention

C-PRF

About this trial

This is an interventional treatment trial for Periodontal Pocket

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patient age ranging from 18-45 years Contralateral sites with probing depth 5mm-7mm associated with premolar and molar teeth with no furcation involvement No systemic disease Not under any medication which effect the outcome of periodontal therapy Exclusion Criteria: History of any periodontal therapy within past 6 months Pregnant and lactating mothers Smokers smoking >10 cigarettes per day Patients with blood disorders or platelet count less than 50000 cells/ µL Patients with known systemic disease Non-compliant patients

Sites / Locations

Krishnadevaraya college of dental sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Probing sites with SPR and C-PRF application

Probing sites with SPR alone

Arm Description

The test group received the C-PRF as adjunct to sacling and root planing

Outcomes

Primary Outcome Measures

Probing pocket Depth

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

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)

Secondary Outcome Measures

Full Information

NCT ID

NCT05958147

First Posted

July 14, 2023

Last Updated

September 13, 2023

Sponsor

Krishnadevaraya College of Dental Sciences & Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05958147

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

February 1, 2023 (Actual)

Primary Completion Date

March 23, 2023 (Actual)

Study Completion Date

March 29, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Krishnadevaraya College of Dental Sciences & Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Periodontal Pocket

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

48 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Probing sites with SPR and C-PRF application

Arm Type

Experimental

Arm Description

The test group received the C-PRF as adjunct to sacling and root planing

Arm Title

Probing sites with SPR alone

Arm Type

No Intervention

Intervention Type

Biological

Intervention Name(s)

C-PRF

Other Intervention Name(s)

Concentrated platelet rich fibrin

Intervention Description

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

Primary Outcome Measure Information:

Title

Probing pocket Depth

Description

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

Time Frame

6 weeks

Title

Relative attachment level

Description

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)

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Facility Information:

Facility Name

Krishnadevaraya college of dental sciences

City

Bangalore

State/Province

Karnataka

ZIP/Postal Code

562157

Country

India

12. IPD Sharing Statement

Learn more about this trial

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

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