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

Periodontal Pocket Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05958147
• Other study ID #: KCDSHEC/IP/2023/P7
• Status: Completed
• Phase: Phase 1
• Start date: February 1, 2023
• Est. completion date: March 29, 2023

Study information

• Verified date: September 2023
• Source: Krishnadevaraya College of Dental Sciences & Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 29, 2023
• Est. primary completion date: March 23, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Periodontal Pocket

Intervention

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

Locations

Country	Name	City	State
India	Krishnadevaraya college of dental sciences	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Krishnadevaraya College of Dental Sciences & Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Probing pocket Depth	measured using a UNC-15 probe (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA)	6 weeks
Primary	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