Scaling and Root Planning With Localized Delivery of Autogenous Growth Factors- Platelet Rich Fibrin (PRF)

Scaling and Root Planning With Localized Delivery of Autogenous Growth Factors- Platelet Rich Fibrin (PRF): A Randomized Split-mouth Clinical Trial

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.

Study Overview

• Status: Withdrawn
• Conditions: Periodontitis Chronic Generalized Moderate; Periodontitis Chronic Generalized Severe
• Intervention / Treatment: Biological: leukocyte platelet rich fibrin (L-PRF); Procedure: Scaling and Root Planing

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:

1. 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.
2. Follow the oral hygiene instructions given

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Richmond, Virginia, United States, 23298
      • Virginia Commonwealth University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Autogenous Growth Factors Left Side; 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.	Biological: leukocyte platelet rich fibrin (L-PRF); 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.; Procedure: Scaling and Root Planing; 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.
EXPERIMENTAL: Autogenous Growth Factors Right Side; 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.	Biological: leukocyte platelet rich fibrin (L-PRF); 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.; Procedure: Scaling and Root Planing; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline to 6 months
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	Baseline to 6 months
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.	Baseline to 6 months
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.	Baseline to 6 months
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.	Baseline to 6 months

Collaborators and Investigators

• Sponsor: Virginia Commonwealth University
• Investigators: Principal Investigator: Thomas Waldrop, DDS, Virginia Commonwealth University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 1, 2022
• Primary Completion (ANTICIPATED): December 1, 2022
• Study Completion (ANTICIPATED): December 1, 2022

Study Registration Dates

• First Submitted: July 16, 2021
• First Submitted That Met QC Criteria: July 16, 2021
• First Posted (ACTUAL): July 27, 2021

Study Record Updates

• Last Update Posted (ACTUAL): May 12, 2022
• Last Update Submitted That Met QC Criteria: May 6, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis
• Other Study ID Numbers: HM20021781

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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