Injectable Platelet Rich Fibrin With Non Surgical Periodontal Therapy
Comparative Evaluation of Local Injectable Platelet Rich Fibrin and Hyaluronic Acid as Adjunctive to Non Surgical Periodontal Therapy: a Randomized Placebo Controlled Clinical Trial
1 other identifier
interventional
120
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2019
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 23, 2019
CompletedFirst Posted
Study publicly available on registry
August 28, 2019
CompletedStudy Start
First participant enrolled
August 28, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 28, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
January 25, 2020
CompletedAugust 28, 2019
August 1, 2019
3 months
August 23, 2019
August 26, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical attachment level (CAL)
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")
3 Months
Secondary Outcomes (1)
Probing pocket depth
3 Months
Study Arms (3)
Negative control
PLACEBO COMPARATORPlacebo gel
Test group 1
EXPERIMENTALHyaluronic acid gel
Test group 2
EXPERIMENTALinjectable prf
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical professor, institute of dental sciences, bareilly
Study Record Dates
First Submitted
August 23, 2019
First Posted
August 28, 2019
Study Start
August 28, 2019
Primary Completion
November 28, 2019
Study Completion
January 25, 2020
Last Updated
August 28, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share