Injectable Platelet Rich Fibrin With Non Surgical Periodontal Therapy
Primary Purpose
CHRONIC PERIODONTITIS
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Placebo gel
Hyaluronic acid gel
Platelet rich fibrin
Sponsored by
About this trial
This is an interventional treatment trial for CHRONIC PERIODONTITIS
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Negative control
Test group 1
Test group 2
Arm Description
Placebo gel
Hyaluronic acid gel
injectable prf
Outcomes
Primary Outcome Measures
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")
Secondary Outcome Measures
Probing pocket depth
Measure as the change in distance from the gingival margin GM to the bottom of the gingival sulcus by using a periodontal probe (UNC 15 "University of North Carolina")
Full Information
NCT ID
NCT04070729
First Posted
August 23, 2019
Last Updated
August 26, 2019
Sponsor
Institute of Dental Sciences, Bareilly, Uttar Pradesh, India
1. Study Identification
Unique Protocol Identification Number
NCT04070729
Brief Title
Injectable Platelet Rich Fibrin With Non Surgical Periodontal Therapy
Official Title
Comparative Evaluation of Local Injectable Platelet Rich Fibrin and Hyaluronic Acid as Adjunctive to Non Surgical Periodontal Therapy: a Randomized Placebo Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
August 28, 2019 (Anticipated)
Primary Completion Date
November 28, 2019 (Anticipated)
Study Completion Date
January 25, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute of Dental Sciences, Bareilly, Uttar Pradesh, India
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CHRONIC PERIODONTITIS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Negative control
Arm Type
Placebo Comparator
Arm Description
Placebo gel
Arm Title
Test group 1
Arm Type
Experimental
Arm Description
Hyaluronic acid gel
Arm Title
Test group 2
Arm Type
Experimental
Arm Description
injectable prf
Intervention Type
Other
Intervention Name(s)
Placebo gel
Other Intervention Name(s)
Cellulose gel
Intervention Description
Localized subgingival application
Intervention Type
Drug
Intervention Name(s)
Hyaluronic acid gel
Intervention Description
Localized subgingival application
Intervention Type
Biological
Intervention Name(s)
Platelet rich fibrin
Intervention Description
Localized subgingival application
Primary Outcome Measure Information:
Title
Clinical attachment level (CAL)
Description
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")
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Probing pocket depth
Description
Measure as the change in distance from the gingival margin GM to the bottom of the gingival sulcus by using a periodontal probe (UNC 15 "University of North Carolina")
Time Frame
3 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Injectable Platelet Rich Fibrin With Non Surgical Periodontal Therapy
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