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Injectable Platelet Rich Fibrin With Non Surgical Periodontal Therapy

I

Institute of Dental Sciences, Bareilly, Uttar Pradesh, India

Status

Unknown

Conditions

CHRONIC PERIODONTITIS

Treatments

Other: Placebo gel
Biological: Platelet rich fibrin
Drug: Hyaluronic acid gel

Study type

Interventional

Funder types

Other

Identifiers

NCT04070729
IEC/IDS50/2019

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

30 to 65 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

120 participants in 3 patient groups, including a placebo group

Negative control
Placebo Comparator group
Description:
Placebo gel
Treatment:
Other: Placebo gel
Test group 1
Experimental group
Description:
Hyaluronic acid gel
Treatment:
Drug: Hyaluronic acid gel
Test group 2
Experimental group
Description:
injectable prf
Treatment:
Biological: Platelet rich fibrin

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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