NCT05958147

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Feb 2023

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 23, 2023

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2023

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 24, 2023

Completed
Last Updated

September 15, 2023

Status Verified

September 1, 2023

Enrollment Period

2 months

First QC Date

July 14, 2023

Last Update Submit

September 13, 2023

Conditions

Periodontal Pocket

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Probing sites with SPR and C-PRF application

EXPERIMENTAL

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

Biological: C-PRF

Probing sites with SPR alone

NO INTERVENTION

Interventions

C-PRFBIOLOGICAL

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

Also known as: Concentrated platelet rich fibrin
Probing sites with SPR and C-PRF application

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Krishnadevaraya college of dental sciences

Bangalore, Karnataka, 562157, India

Location

MeSH Terms

Conditions

Periodontal Pocket

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2023

First Posted

July 24, 2023

Study Start

February 1, 2023

Primary Completion

March 23, 2023

Study Completion

March 29, 2023

Last Updated

September 15, 2023

Record last verified: 2023-09

Locations

IN(1)