Periodontitis Chronic Generalized SeverePhase 3NCT04978324
Scaling and Root Planning With Localized Delivery of Autogenous Growth Factors- Platelet Rich Fibrin (PRF)
A Phase 3 study testing leukocyte platelet rich fibrin (L-PRF) and Scaling and Root Planing in people with Periodontitis Chronic Generalized Severe and Periodontitis Chronic Generalized Moderate, run by Virginia Commonwealth University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis Chronic Generalized Severe, Periodontitis Chronic Generalized Moderate
- What is being tested?
- leukocyte platelet rich fibrin (L-PRF) and Scaling and Root Planing
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2022to Dec 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: 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.
Read the 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
- Being tested
- leukocyte platelet rich fibrin (L-PRF), Scaling and Root Planing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
leukocyte platelet rich fibrin (L-PRF)Biological
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.
Scaling and Root PlaningProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Autogenous Growth Factors Left Side | Experimental | 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. Receives: Biological: leukocyte platelet rich fibrin (L-PRF); Procedure: Scaling and Root Planing |
| Autogenous Growth Factors Right Side | Experimental | 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. Receives: Biological: leukocyte platelet rich fibrin (L-PRF); Procedure: Scaling and Root Planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2021
- Study startMay 2022 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: Fellow graduated before successfully enrolling any participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis Chronic Generalized SevereStudies of the same condition, open and under way.
- More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Virginia Commonwealth University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Thomas Waldrop, DDS, Principal investigator, Virginia Commonwealth University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04978324
- Sponsor's protocol ID
- HM20021781
- Status last verified
- May 2022
- First submitted
- 16 Jul 2021
- Last updated
- 12 May 2022
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scaling and Root Planning With Localized Delivery of Autogenous Growth Factors- Platelet Rich Fibrin (PRF): A Randomized Split-mouth Clinical Trial
- ClinicalTrials.gov ID
- NCT04978324
- Acronym / sponsor ID
- HM20021781
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Fellow graduated before successfully enrolling any participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Virginia Commonwealth UniversityUniversity, hospital or other
- Study start
- May 2022 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 27 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autogenous Growth Factors Left Side | Experimental | Biological: leukocyte platelet rich fibrin (L-PRF), Procedure: Scaling and Root Planing5-8mm 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. |
| Autogenous Growth Factors Right Side | Experimental | Biological: leukocyte platelet rich fibrin (L-PRF), Procedure: Scaling and Root Planing5-8mm 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | Autogenous Growth Factors Left Side, Autogenous Growth Factors Right Side |
| Scaling and Root PlaningScaling 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. | Procedure or surgery | Autogenous Growth Factors Left Side, Autogenous Growth Factors Right Side |
Primary outcome
Change in probing depths (PD)
Time frame: Baseline to 6 months
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)
Time frame: Baseline to 6 months
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)
Time frame: Baseline to 6 months
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)
Time frame: Baseline to 6 months
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
Time frame: Baseline to 6 months
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- Individual participant dataSharing planned: No
Related trials for Periodontitis Chronic Generalized Severe
RecruitingPhase 2
3-Month Clinical Trial of Liquid S-PRF in Periodontal Debridement for Periodontitis Stages II-IV
Periodontitis Stage II, Periodontitis Stage III
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thomas Waldrop, DDS principal investigator
Virginia Commonwealth University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing leukocyte platelet rich fibrin (L-PRF) and Scaling and Root Planing in people with Periodontitis Chronic Generalized Severe and Periodontitis Chronic Generalized Moderate, run by Virginia Commonwealth University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in probing depths (PD) (time frame: Baseline to 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2022.