Clinical trial NCT04978324: 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
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Periodontitis Chronic Generalized Severe
Periodontitis Chronic Generalized Moderate
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2021-07-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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:

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

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

Primary outcomes:
measure: Change in probing depths (PD)
timeFrame: Baseline to 6 months
measure: Change in clinical attachment level (CAL)
timeFrame: Baseline to 6 months
measure: Bleeding on probing (BOP)
timeFrame: Baseline to 6 months
measure: Plaque index (PI)
timeFrame: Baseline to 6 months
measure: Gingival index
timeFrame: Baseline to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Thomas Waldrop, DDS
role: PRINCIPAL_INVESTIGATOR
References: