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N/A N=36 Randomized Double-blind Treatment

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

Pulpal Necrosis

Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Oct 2021
Primary outcome: Primary: Vitality of Teeth (Units) Using Thermal and Percussion Sensitivity Trend Observed During Study Duration (3-11 Months) — .559; .592; .065; .040 Teeth

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Left Tooth Platelet Rich Fibrin; Right Tooth Implant Alone (Procedure); Right Tooth Platelet Rich Fibrin; Left Tooth Implant Alone (Procedure)
Age
Adult, Older Adult · 19+ yrs
Sex
All
Sponsor
University of Nebraska
Primary completion
Jun 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Vitality of Teeth (Units) Using Thermal and Percussion Sensitivity Trend Observed During Study Duration (3-11 Months)
.559; .592; .065; .040
PRIMARY
Vitality of Teeth Using Electronic Pulp Test (EPT Units) Trend Observed During Study Duration (3-11 Months)
57; 55.45

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. 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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • exclusion criteria will include: individuals with systemic illnesses that could compromise vascularity or healing,
  • patients who are pregnant,
  • or bisphosphonates.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02477358). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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