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

NCT02477358 | Completed Results

• 1 other identifier: 0443-14-FB
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pulpal Necrosis

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

• 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.

  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.

Study Arms (2)

PRF Treated

EXPERIMENTAL

Subjects 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.

Procedure: Left Tooth Platelet Rich Fibrin; Right Tooth Implant Alone; Procedure: Right Tooth Platelet Rich Fibrin; Left Tooth Implant Alone

Control

NO INTERVENTION

Subjects 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.

Interventions

Left Tooth Platelet Rich Fibrin; Right Tooth Implant Alone PROCEDURE

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.

PRF Treated

Right Tooth Platelet Rich Fibrin; Left Tooth Implant Alone PROCEDURE

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.

PRF Treated

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• patients who are pregnant,
• or bisphosphonates.

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska, College of Dentistry

Lincoln, Nebraska, 68505, United States

Location

MeSH Terms

Conditions

Dental Pulp Necrosis

Condition Hierarchy (Ancestors)

Dental Pulp Diseases; Tooth Diseases; Stomatognathic Diseases; Necrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Limitations of study include bias in patient reporting of sensation for vitality testing, lack of control of possible contributing factors including bruxism, and finally differing values for time out of mouth for control vs experimental groups.

Results Point of Contact

• Title: Elisabeth Easley
• Organization: University of Nebraska Medical Center

eleasley@gmail.com

530-524-6020

Study Officials

• Elisabeth L Easley, DMD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participant and Operating Surgeon were masked to tooth designation. Principal investigator/outcomes assessor aware of designation.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 26, 2015
• First Posted: June 22, 2015
• Study Start: September 29, 2014
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: October 4, 2023
• Results First Posted: October 20, 2021

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)