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Clinical Trials/NCT04070729
NCT04070729
Unknown
N/A

Comparative Evaluation of Local Injectable Platelet Rich Fibrin and Hyaluronic Acid as Adjunctive to Non Surgical Periodontal Therapy: a Randomized Placebo Controlled Clinical Trial

Institute of Dental Sciences, Bareilly, Uttar Pradesh, India0 sites120 target enrollmentAugust 28, 2019

Overview

Phase
N/A
Intervention
Platelet rich fibrin
Conditions
CHRONIC PERIODONTITIS
Sponsor
Institute of Dental Sciences, Bareilly, Uttar Pradesh, India
Enrollment
120
Primary Endpoint
Clinical attachment level (CAL)
Last Updated
6 years ago

Overview

Brief Summary

Clinical evaluation of local subgingival application of injectable platelet-rich fibrin ( i-PRF ) for chronic periodntitis as adjunctive to non surgical therapy and compare it with hyaluronic acid.

120 periodontal patients will receive a scaling and root planing ( non surgical periodontal therapy). Equal number of patients will receive subgingival application of i-PRF, hyaluronic acid or placebo gel as the adjunction to non surgical therapy.

Detailed Description

The aim of the study is to evaluate and compare the clinical efficacy of subgingival application of i-PRF and hyaluronic acid gel as adjunctive to non-surgical periodontal therapy. 120 periodontal patients will receive traditional mechanical supra and subgingival scaling and root planing. Patients were randomly allocated in three groups. Group 1, 2 and 3 will receive subginigval application of placebo, hyaluronic acid gel and i prf respectively. Clinical parameters will be evaluated: plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing depth (PD), clinical attachment level (CAL), gingival recession (GR). Clinical measurements will be performed at baseline, 1 month and at 3 months.

Registry
clinicaltrials.gov
Start Date
August 28, 2019
End Date
January 25, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Institute of Dental Sciences, Bareilly, Uttar Pradesh, India
Responsible Party
Principal Investigator
Principal Investigator

ASHISH AGARWAL

Clinical professor, institute of dental sciences, bareilly

Institute of Dental Sciences, Bareilly, Uttar Pradesh, India

Eligibility Criteria

Inclusion Criteria

  • Patients are in general good health.
  • Patients having minimum of 20 permanent teeth.
  • They have not taken medication known to interfere with periodontal tissue health or healing in the preceding 6 months.
  • Presence of periodontal pockets (≥5 mm) and clinicala ttachment level \> 5 mm.

Exclusion Criteria

  • Immunosuppressive systemic diseases (like cancer, AIDS, diabetes etc.)
  • Clotting and Hematological disorders
  • Patients with grade III mobility.
  • Patients with smoking and alcohol consuming habit.
  • Pregnant and lactating female.
  • Medications influence on the gingival and periodontal tissues (like calcium channel blockers, or Long-term steroid use)
  • The teeth with poor filling and ill fitted restorations

Arms & Interventions

Test group 2

injectable prf

Intervention: Platelet rich fibrin

Negative control

Placebo gel

Intervention: Placebo gel

Test group 1

Hyaluronic acid gel

Intervention: Hyaluronic acid gel

Outcomes

Primary Outcomes

Clinical attachment level (CAL)

Time Frame: 3 Months

Measure as the change in distance from the cementoenamel junction to the bottom of the gingival sulcus by using a periodontal probe (UNC 15 "University of North Carolina")

Secondary Outcomes

  • Probing pocket depth(3 Months)

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