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Regenerative Endodontic Procedure of Immature Permanent Teeth With Apical Periodontitis Using PRF

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ClinicalTrials.gov Identifier: NCT02801552
Recruitment Status : Unknown
Verified June 2016 by Xiaojing Huang, Fujian Medical University.
Recruitment status was:  Recruiting
First Posted : June 16, 2016
Last Update Posted : June 17, 2016
Sponsor:
Information provided by (Responsible Party):
Xiaojing Huang, Fujian Medical University

Brief Summary:
This study evaluates the clinical effect of regenerative endodontic procedure using PRF in immature permanent teeth with apical periodontitis. Half of participants will receive the PRF instead of blood clots in the regenerative endodontic procedure, while the other half will receive a blood clots in the regenerative endodontic procedure.

Condition or disease Intervention/treatment Phase
Periapical Periodontitis Tooth Diseases Stomatognathic Diseases Device: PRF Not Applicable

Detailed Description:
The conventional method of regenerative endodontic procedure using a blood clot as scaffold materials has shown successful results. However, it is very difficult to induce bleeding and place mineral trioxide aggregate over a blood clot. Platelet-rich fibrin (PRF), a second-generation platelet concentrate. PRF is a matrix of autologous fibrin containing a large quantity of platelets, growth factors and leukocytes. PRF preparation technique is very simple, inexpensive and doesn't require any chemical agents. The purpose of this study is to test the hypothesis that the use of PRF in regenerative endodontic procedure of immature permanent teeth with apical periodontitis will accelerate periapical bone healing and stimulate the root maturation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Regenerative Endodontic Procedure of Immature Permanent Teeth With Apical Periodontitis Using Platelet-rich Fibrin : A Pilot Randomized Controlled Trial
Study Start Date : May 2013
Estimated Primary Completion Date : November 2016
Estimated Study Completion Date : February 2017

Arm Intervention/treatment
Experimental: Regenerative Endodontic Procedure + PRF
Visit 1: root canal dressing with triple antibiotic paste. Visit 2: a 5 ml sample of whole blood was drawn intravenously from the patient's forearm. The blood sample is centrifuged at 400 g for 10 min. The prepared PRF membrane is cut into segments, the fragments are placed into the canal space. The coronal is sealed mineral trioxide aggregate and composite resin.
Device: PRF
Regenerative Endodontic Procedure with PRF: autologous PRF will be used instead of blood clot in the second vist.
Other Name: mineral trioxide aggregate

No Intervention: Regenerative Endodontic Procedure
Regenerative Endodontic Procedure Visit 1: root canal dressing with triple antibiotic paste. Visit 2: Blood clot formation is induced in the root canal after disinfection. No PRF was used in this group. Then the canal access is sealed with mineral trioxide aggregate and composite resin.



Primary Outcome Measures :
  1. Evidence of periapical healing [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Evidence of root development [ Time Frame: 24 months ]
  2. Evidence of pulp sensibility [ Time Frame: 24 months ]
    a positive response to pulp sensibility tests include cold test and electric pulp testing



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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Between 6 and 18 years of age
  • Provision of Informed Consent
  • Cooperative in the dental chair
  • Permanent immature teeth with apical periodontitis and incomplete root development

Exclusion Criteria:

  • Have a medical history that may complicate treatment
  • Unlikely to be able to comply with the study procedures

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02801552


Contacts
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Contact: Yuemin Chen, MDS +8615806033646 757437531@qq.com

Locations
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China, Fujian
School and Hospital of Stomatology, Fujian Medical University Recruiting
Fuzhou, Fujian, China, 350002
Contact: Yuemin Chen, MDS    +8615806033646    757437531@qq.com   
Sponsors and Collaborators
Fujian Medical University
Investigators
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Study Chair: Xiaojing Huang, PhD School and Hospital of Stomatology, Fujian Medical University
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Responsible Party: Xiaojing Huang, DDS, PhD, Professor, Fujian Medical University
ClinicalTrials.gov Identifier: NCT02801552    
Other Study ID Numbers: JS14031
First Posted: June 16, 2016    Key Record Dates
Last Update Posted: June 17, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Xiaojing Huang, Fujian Medical University:
regenerative endodontic treatment
platelet-rich fibrin
Immature permanent tooth
apical periodontitis
Additional relevant MeSH terms:
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Periodontitis
Tooth Diseases
Periapical Periodontitis
Stomatognathic Diseases
Periodontal Diseases
Mouth Diseases
Periapical Diseases
Jaw Diseases