Scaling and Root Planning With Localized Delivery of Autogenous Growth Factors- Platelet Rich Fibrin (PRF)
Primary Purpose
Periodontitis Chronic Generalized Severe, Periodontitis Chronic Generalized Moderate
Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
leukocyte platelet rich fibrin (L-PRF)
Scaling and Root Planing
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis Chronic Generalized Severe
Eligibility Criteria
Inclusion Criteria:
- Systemically healthy (ASA 1 or 2) adults over the age of 18
- A similar number of bilateral 5-8 mm pocket depths
- Diagnosed with Stage II or Stage III chronic periodontitis.
Exclusion Criteria:
- Uncontrolled systemic illness that may affect healing or clotting such as diabetes mellitus, immunocompromisation, bleeding disorders, ongoing chemo- or radiotherapy
- Active smokers
- Pregnancy
- Periodontal treatment in the last six months
- Antibiotic therapy within three months prior to treatment
- Taking medications that could affect periodontal status or healing
Sites / Locations
- Virginia Commonwealth University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Autogenous Growth Factors Left Side
Autogenous Growth Factors Right Side
Arm Description
5-8mm pockets on the left side of the mouth will receive insertion of small treatment after deep cleaning. The right side of the mouth will receive deep cleaning only, the standard of care.
5-8mm pockets on the right side of the mouth will receive insertion of small treatment after deep cleaning. The left side of the mouth will receive deep cleaning only, the standard of care.
Outcomes
Primary Outcome Measures
Change in probing depths (PD)
PD will be measured from the gingival margin to pocket base using a participant specific fabricated removable resin stent with an assigned #15 UNC probe.
Change in clinical attachment level (CAL)
CAL will be measured from cemento-enamel junction CEJ to the base of the pocket using the same stent as PD
Bleeding on probing (BOP)
Bleeding on probing (BOP) will be recorded on an ordinal scale where sites that will bleed on probing will be given a score of 1 while sites that don't bleed will be given a score of 0.
Plaque index (PI)
PI will be recorded using the Loe and Silness Index. Scores range from 0 - No plaque to 3 - Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Gingival index
GI will be recorded using the Loe and Silness gingival index. Scores range from 0 - Normal gingiva to 3 - Severe inflammation - marked redness and edema, ulceration. Tendency toward spontaneous bleeding.
Secondary Outcome Measures
Full Information
NCT ID
NCT04978324
First Posted
July 16, 2021
Last Updated
May 6, 2022
Sponsor
Virginia Commonwealth University
1. Study Identification
Unique Protocol Identification Number
NCT04978324
Brief Title
Scaling and Root Planning With Localized Delivery of Autogenous Growth Factors- Platelet Rich Fibrin (PRF)
Official Title
Scaling and Root Planning With Localized Delivery of Autogenous Growth Factors- Platelet Rich Fibrin (PRF): A Randomized Split-mouth Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Fellow graduated before successfully enrolling any participants
Study Start Date
May 2022 (Anticipated)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The purpose of this research study is to find out about the effect of growth factors extracted from blood on improving healing of periodontal pockets (Gum pockets) after deep gum cleaning.
Detailed Description
Blood has a lot of cells that help with healing and regeneration. These cells could be obtained by spinning blood in a centrifuge machine which allows the cells to separate at high spinning forces. After spinning, the blood will be separated into 3 different layers. The middle layer has the highest concentration of cells that help in healing and it is called the leukocyte platelet rich plasma (L-PRF).
The aim of this study is to use participant's own blood to retrieve (L-PRF) and place it in the diseased tissue around teeth, after the deep cleaning, to examine its effect in improving the healing and compare the results with gum pockets that haven't received L-PRF
In this study, participants will be asked to do the following things:
Visit VCU Graduate Periodontics clinic 6 times for scheduled study visits after the initial periodontal exam.:
1st appointment: A digital impression of upper and lower teeth using an intraoral scanner, a light source laser that will capture digital impressions of the teeth, will be taken. These digital impressions will be used to create removable resin stents that fit on top of the teeth which will help in obtaining accurate and reproducible clinical measurements. The stents will be used on almost all participant's visits to the graduate periodontics clinic for the duration of the study for data collection.
2nd and 3rd appointment: The deep cleaning will be divided into 2 appointments which should be less than 2 weeks apart. During each appointment, one arch, either the upper or the lower arch, will be scaled and root planed. Local anesthesia will be used to anesthetize the participant before the cleaning. Ultrasonic cleaner and hand instruments will be used for the deep cleaning. After finishing the deep cleaning, 36 ml of participant's blood will be collected in 4 tubes through the antecubital vein. The tubes will be spun in an FDA approved spinning machine to obtain the liquid and membrane forms of the L-PRF. The L-PRF will then be inserted in the test sites on one side of the arch while the other side will not receive the L-PRF.
4th appointment: Prophylaxis and plaque control 2 weeks after 2nd appointment.
5th appointment: Evaluation of deep periodontal cleaning and data collection 4-5 weeks after the 2nd appointment
6th appointment: Periodontal cleaning and data collection 3 months after 2nd appointment.
Follow the oral hygiene instructions given
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis Chronic Generalized Severe, Periodontitis Chronic Generalized Moderate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Autogenous Growth Factors Left Side
Arm Type
Experimental
Arm Description
5-8mm pockets on the left side of the mouth will receive insertion of small treatment after deep cleaning. The right side of the mouth will receive deep cleaning only, the standard of care.
Arm Title
Autogenous Growth Factors Right Side
Arm Type
Experimental
Arm Description
5-8mm pockets on the right side of the mouth will receive insertion of small treatment after deep cleaning. The left side of the mouth will receive deep cleaning only, the standard of care.
Intervention Type
Biological
Intervention Name(s)
leukocyte platelet rich fibrin (L-PRF)
Intervention Description
Participants blood will be spun to obtain L-PRF strips and liquid L-PRF. Pockets will receive insertion of small L-PRF strips followed by liquid L-PRF injections to fill the 5-8mm pockets of the test side.
Intervention Type
Procedure
Intervention Name(s)
Scaling and Root Planing
Intervention Description
Scaling and root planing, which is the standard of care, will be performed on the control side using Cavitron and hand scalers on test and control sides under local anesthesia.
Primary Outcome Measure Information:
Title
Change in probing depths (PD)
Description
PD will be measured from the gingival margin to pocket base using a participant specific fabricated removable resin stent with an assigned #15 UNC probe.
Time Frame
Baseline to 6 months
Title
Change in clinical attachment level (CAL)
Description
CAL will be measured from cemento-enamel junction CEJ to the base of the pocket using the same stent as PD
Time Frame
Baseline to 6 months
Title
Bleeding on probing (BOP)
Description
Bleeding on probing (BOP) will be recorded on an ordinal scale where sites that will bleed on probing will be given a score of 1 while sites that don't bleed will be given a score of 0.
Time Frame
Baseline to 6 months
Title
Plaque index (PI)
Description
PI will be recorded using the Loe and Silness Index. Scores range from 0 - No plaque to 3 - Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
Time Frame
Baseline to 6 months
Title
Gingival index
Description
GI will be recorded using the Loe and Silness gingival index. Scores range from 0 - Normal gingiva to 3 - Severe inflammation - marked redness and edema, ulceration. Tendency toward spontaneous bleeding.
Time Frame
Baseline to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Systemically healthy (ASA 1 or 2) adults over the age of 18
A similar number of bilateral 5-8 mm pocket depths
Diagnosed with Stage II or Stage III chronic periodontitis.
Exclusion Criteria:
Uncontrolled systemic illness that may affect healing or clotting such as diabetes mellitus, immunocompromisation, bleeding disorders, ongoing chemo- or radiotherapy
Active smokers
Pregnancy
Periodontal treatment in the last six months
Antibiotic therapy within three months prior to treatment
Taking medications that could affect periodontal status or healing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Waldrop, DDS
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Scaling and Root Planning With Localized Delivery of Autogenous Growth Factors- Platelet Rich Fibrin (PRF)
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