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Pulpal NecrosisNCT02477358

The Use of Platelet Rich Fibrin in Pulpal and Periodontal Regeneration in Mature Teeth

A study testing Left Tooth Platelet Rich Fibrin; Right Tooth Implant Alone and Right Tooth Platelet Rich Fibrin; Left Tooth Implant Alone in people with Pulpal Necrosis, run by University of Nebraska at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In cases of permanent tooth avulsion, it is widely accepted that some necrosis always occurs after avulsion injury. If the pulp tissue does not revascularize or if endodontic therapy is not performed, the pulp space can become infected. Read more about this study

Who is it for?
Ages 19 years and olderHealthy volunteers can take part
Conditions the study is for
Pulpal Necrosis
What is being tested?
Left Tooth Platelet Rich Fibrin; Right Tooth Implant Alone and Right Tooth Platelet Rich Fibrin; Left Tooth Implant Alone
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteUnited States
Study dates
29 Sep 2014to 1 Jun 2016
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 19 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • any adult with single rooted vital teeth previously treatment planned for extraction to meet their prosthetic or orthodontic needs.

Who cannot join

  • exclusion criteria will include: individuals with systemic illnesses that could compromise vascularity or healing,
  • patients who are pregnant,
  • or bisphosphonates.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Nebraska, College of Dentistry

    Lincoln, Nebraska, 68505

Other trials in United States

About this study

In cases of permanent tooth avulsion, it is widely accepted that some necrosis always occurs after avulsion injury. If the pulp tissue does not revascularize or if endodontic therapy is not performed, the pulp space can become infected. Platelet rich fibrin (PRF) is a second generation platelet concentrate that allows the clinician to obtain fibrin membranes enriched with platelets and growth factors from an anticoagulant-free blood harvest. Clinical relevance of PRF and revascularization has been demonstrated in several case studies of avulsion. To date no human clinical trials have been performed evaluating the effectiveness of PRF on pulpal revascularization after reimplantation and its benefits in limiting inflammation. The following study consists of two phases: Phase 1: An in vitro model evaluating the effects of PRF in limiting inflammatory response of pdl cell cultures in the presence of an inflammatory mediators. Phase 2: An in vivo model utilizing mature teeth previously treatment planned for extraction, treating with PRF, reimplanting teeth and following for three to four months before extracting and performing histological analysis. If PRF is capable of promoting revascularization in mature teeth the potential benefits extend to limiting the need for endodontic therapy following mature tooth avulsion, potential for mature tooth transplantation in situations of congenitally missing teeth, and utilization of PRF in endodontic revascularization therapy.

Read the detailed description

When a tooth is avulsed, it is separated from its socket causing damage to the attachment apparatus. The periodontal ligament (pdl) is a group of specialized connective tissue fibers that attaches the cementum of the root (outer layer) to the alveolar bone. Avulsion can cause damage to the pdl and possible cemental tears. If the periodontal ligament is left attached to the root and minimal time lapse occurs damage to the tissues is usually limited. In these cases, reimplantation is a widely accepted treatment; however the long term success of an avulsed tooth is dependent on various factors. When excessive drying occurs prior to re-implantation, a severe inflammatory response is elicited directly on the root surface which may result in osseous replacement or replacement resorption. Some necrosis always occurs after avulsion injury, and while the necrotic pulp is of little consequence, this necrotic tissue is at high risk for bacterial contamination. If the pulp tissue does not revascularize or if endodontic therapy is not performed, the pulp space can become infected. It has been suggested that treatment strategies should attempt to limit peri-radicular inflammation therefore promoting favorable cemental healing and limiting unfavorable osseous replacement.

Platelet rich fibrin (PRF) is a second generation platelet concentrate that allows the clinician to obtain fibrin membranes enriched with platelets and growth factors from an anticoagulant-free blood harvest and without the addition of artificial biochemical modification. PRF has demonstrated clinical relevance through its ability to stimulate cell proliferation of osteoblasts, gingival fibroblasts, and periodontal ligament (PDL) cells. In addition, PRF has been shown to limit epithelial cell growth therefore promoting connective tissue and alveolar bone regeneration and inhibiting epithelial proliferation. These properties make it a favorable product for surgical procedures requiring micro vascularization.

In vitro studies with PRF and canine dental pulp cells demonstrate PRF's ability to promote chemotaxis and proliferation of the pulp cells and contributed to pulp repair. When PRF was combined with human dental pulp cells derived from extracted third molars it did not interfere with vitality and stimulated proliferation and differentiation. Additionally it upregulated the expression of osteoprotegerin and alkaline phosphatase.

Animal models evaluated PRF granules combined with human pdl stem cells and placed them on the root surface of freshly extracted canine teeth. The teeth were then reimplanted and evaluated histologically after a healing phase. A regeneration of the PDL-like tissue and reduction in ankylosis and inflammation were noted in animals with the PRF granules.

Clinical relevance of PRF and revascularization has been demonstrated in several case studies of avulsion. These case studies utilized a general protocol of minimally instrumenting the avulsed tooth. One study performed a 3 mm resection of the root apex followed by minimal instrumentation of the canal. Blood is then drawn from the patient and PRF is prepared via Choukroun's method. The PRF is then placed on the root surface and condensed into the canal. The tooth was then reimplanted, splinted, and the patient followed for up to 24 months. The tooth tested vital to thermal and percussion testing and radiographically did not show signs of replacement resorption or inflammation.

To date no human studies have been performed evaluating the effectiveness of PRF on pulpal revascularization after reimplantation and its benefits in limiting inflammation. Additionally, only histological evidence of the benefits of PRF has been demonstrated in animal models. If PRF is capable of promoting revascularization in mature teeth the potential benefits extend to limiting the need for endodontic therapy following mature tooth avulsion, potential for mature tooth transplantation in situations of congenitally missing teeth, and utilization of PRF in endodontic revascularization therapy.

The following research would consist of two phases: Phase 1. An in vitro model evaluating the effects of PRF in limiting inflammatory response of pulp and pdl cell cultures in the presence of an inflammatory mediators. Phase 2. An in vivo model utilizing mature teeth previously treatment planned for extraction, treating in accordance to the procedure documented by one group, reimplanting teeth and following for three to four months before extracting and performing histological analysis.

Conditions
Pulpal Necrosis
Being tested
Left Tooth Platelet Rich Fibrin; Right Tooth Implant Alone, Right Tooth Platelet Rich Fibrin; Left Tooth Implant Alone
Medical subject headings
Dental Pulp Necrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Left Tooth Platelet Rich Fibrin; Right Tooth Implant AloneProcedure or surgery

    All study participants will have two teeth extracted and 2 mm of root removed. Half of the subjects will have platelet rich fibrin endodontic revascularization therapy will be applied to the left tooth socket only. The right tooth is implanted alone. Each tooth is replaced and splinted to the adjacent teeth. Teeth are followed for 3 months and then tested for vitality before extracting and examining histologically.

  • Right Tooth Platelet Rich Fibrin; Left Tooth Implant AloneProcedure or surgery

    All study participants will have two teeth extracted and 2 mm of root removed. Half of the subjects will have platelet rich fibrin endodontic revascularization therapy to the right tooth socket only. The left tooth is implanted alone. Each tooth is replaced and splinted to the adjacent teeth. Teeth are followed for 3 months and then tested for vitality before extracting and examining histologically.

Study groups in NCT02477358
Study groupRoleWhat they receive
PRF TreatedExperimentalSubjects will be randomized to either receive either left tooth platelet rich fibrin; right tooth implant alone, OR right tooth platelet rich fibrin; left tooth implant alone. Following treatment each tooth is replaced and splinted to the adjacent teeth. Teeth are followed for 3 months and then tested for vitality before extracting and examining histologically.
Receives: Procedure: Left Tooth Platelet Rich Fibrin; Right Tooth Implant Alone; Procedure: Right Tooth Platelet Rich Fibrin; Left Tooth Implant Alone
ControlNo interventionSubjects will be randomized to either receive either left tooth platelet rich fibrin; right tooth implant alone, OR right tooth platelet rich fibrin; left tooth implant alone. Following treatment each tooth is replaced and splinted to the adjacent teeth. Teeth are followed for 3 months and then tested for vitality before extracting and examining histologically.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vitality of Teeth (Units) Using Thermal and Percussion Sensitivity Trend Observed During Study Duration (3-11 Months)

    Teeth (units) measuring vital via the following tests: thermal, percussion. Thermal was utilized with endo cold spray and percussion from tapping on teeth with mouth mirror.

    Measured: 3-11 months. Each participant was measured for as long as it took to complete their prosthesis. The minimum study duration was 3 months and the maximum duration was 11 months in one subject.

  2. Vitality of Teeth Using Electronic Pulp Test (EPT Units) Trend Observed During Study Duration (3-11 Months)

    Teeth (units) measuring vital via the following tests: EPT utilizing EPT units (0-80). There is no specific number that suggests vital vs un-vital but rather it is a trend towards un-vital which is determined as 80.

    Measured: 3-11 months. Each participant was measured for as long as it took to complete their prosthesis. The minimum study duration was 3 months and the maximum duration was 11 months in one subject.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2015 (estimated)
  2. Study start29 Sep 2014
  3. Primary completion1 Jun 2016
  4. Study completion1 Jun 2016

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Factorial
Model description
Multiple teeth (2-6 teeth per participant) will be removed with the root attached and then half of the total teeth(per participant) will be placed back in the socket with Platelet Rich Fibrin (PRF) and the other half will be placed in the socket without PRF.
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02477358
Sponsor's protocol ID
0443-14-FB
Status last verified
Sep 2023
First submitted
26 May 2015
Last updated
4 Oct 2023
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Left Tooth Platelet Rich Fibrin; Right Tooth Implant Alone and Right Tooth Platelet Rich Fibrin; Left Tooth Implant Alone in people with Pulpal Necrosis, run by University of Nebraska 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 1 inclusion and 3 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: finished, as of the sponsor's last update on 4 Oct 2023. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Vitality of Teeth (Units) Using Thermal and Percussion Sensitivity Trend Observed During Study Duration (3-11 Months) (time frame: 3-11 months. Each participant was measured for as long as it took to complete their prosthesis. The minimum study duration was 3 months and the maximum duration was 11 months in one subject.). The study lists 2 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 4 Oct 2023.

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