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Evaluation of Survival of Mature Second Premolar Treated With Regenerative Techniques

Primary Purpose

Carious Teeth

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
PRP
PRF
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carious Teeth

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients who are free from any physical or mental handicapping condition with no underlying systemic diseases.

Non-pregnant females Single canalled second premolar

  • Patients having non-vital, mature, second premolar teeth, radiographic evidence of periapical lesion.
  • Positive patient/Guardian compliance for participation in the study.

Exclusion Criteria:

  • Any known sensitivity or adverse reactions to medicaments or pharmaceuticals necessary to complete the trial.

Non-restorable coronal portion of teeth involved in the trial. Vital teeth Immature teeth Traumatized teeth Radiographic evidence of external or internal root resorption. Any criterion, not mentioned in the inclusion criteria

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    group A

    group B

    Arm Description

    prp revascularization

    treatment of affected teeth using platelet rich fibrin by applying prf in steril root canal

    Outcomes

    Primary Outcome Measures

    Survival
    how long will the tooth survive after treatment, testing the durability of tooth

    Secondary Outcome Measures

    healing
    measuring the density of lesion using the cone beam CT
    vitality
    after how many days will the tooth respond normaly to stimulus

    Full Information

    First Posted
    September 20, 2016
    Last Updated
    September 23, 2016
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02915419
    Brief Title
    Evaluation of Survival of Mature Second Premolar Treated With Regenerative Techniques
    Official Title
    Evaluation of Survival of Mature Second Premolar With Periapical Lesion Following Different Regenerative Treatment Protocols
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2016 (undefined)
    Primary Completion Date
    October 2017 (Anticipated)
    Study Completion Date
    October 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    This study aims to compare the ability of different regenerative protocols in the treatment of mature necrotic
    Detailed Description
    American Dental Association adopted the tissue engineering concept and pulp regeneration in 2009. Regeneration was focused on the treatment of immature necrotic teeth so as to allow root completion, improving both the functionality and durability of the affected tooth. Utilizing a blood clot in the affected tooth with immature roots was very beneficial, as it acts as a scaffold for the migration of stem cells and morphogens to allow regeneration . Based on the success of pulp regeneration in treating immature teeth, ambitious dentists started to look forward on regenerating the pulp of mature teeth as a substitution to the conventional root canal treatment. On the other hand, lots of clinicians were very doubtful about treating mature teeth with the same protocol, as the small apical foramen might not provide a good portal for the entry of stem cells and growth factors, which in turn is very important for the success of pulp regeneration.Doubts in treating mature apex encouraged researchers to look for an alternative to the stem cells other than the apical papilla, from this concept the idea for using an alternative source of stem cells and growth factors as platelet rich plasma (PRP) emerged. The use of platelet rich plasma (PRP) as a potentially ideal scaffold for regenerative endodontic therapy has been reported in the treatment of immature teeth. However, the use of bovine thrombin for the activation of PRP has been an issue of controversy, as it requires non autologous anticoagulant known to hinder the process of pulp regeneration. This led to the development of the second generation, platelet concentrate known as Choukroun's platelet rich fibrin (PRF) which is totally autologous in nature. Platelet rich fibrin (PRF) was very promising, but it is debatable whether to use PRP or PRF.The objective of this study is to evaluate novel regenerative techniques, utilizing platelet rich plasma and platelet rich fibrin in treatment of second premolar teeth with necrotic pulp, mature apex, and periapical lesion. This is a trial to prolong the survival of the affected tooth, and to aid in complete healing of periapical lesion, and to regain pulp vitality and sensitivity.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Carious Teeth

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    group A
    Arm Type
    Active Comparator
    Arm Description
    prp revascularization
    Arm Title
    group B
    Arm Type
    Experimental
    Arm Description
    treatment of affected teeth using platelet rich fibrin by applying prf in steril root canal
    Intervention Type
    Biological
    Intervention Name(s)
    PRP
    Intervention Description
    platelet rich plasma
    Intervention Type
    Biological
    Intervention Name(s)
    PRF
    Intervention Description
    PLATELET RICH FIBRIN
    Primary Outcome Measure Information:
    Title
    Survival
    Description
    how long will the tooth survive after treatment, testing the durability of tooth
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    healing
    Description
    measuring the density of lesion using the cone beam CT
    Time Frame
    1 year
    Title
    vitality
    Description
    after how many days will the tooth respond normaly to stimulus
    Time Frame
    1 year
    Other Pre-specified Outcome Measures:
    Title
    sensitivity
    Description
    after how many days will the tooth respond positively to electric pulp tester
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    15 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients who are free from any physical or mental handicapping condition with no underlying systemic diseases. Non-pregnant females Single canalled second premolar Patients having non-vital, mature, second premolar teeth, radiographic evidence of periapical lesion. Positive patient/Guardian compliance for participation in the study. Exclusion Criteria: Any known sensitivity or adverse reactions to medicaments or pharmaceuticals necessary to complete the trial. Non-restorable coronal portion of teeth involved in the trial. Vital teeth Immature teeth Traumatized teeth Radiographic evidence of external or internal root resorption. Any criterion, not mentioned in the inclusion criteria
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    wagih ali, ass.lecturer
    Phone
    00201065550505
    Email
    wagihtarek.a@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    wagih ali, ass lecturer
    Organizational Affiliation
    Cairo University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    26071100
    Citation
    Wang Y, Zhu X, Zhang C. Pulp Revascularization on Permanent Teeth with Open Apices in a Middle-aged Patient. J Endod. 2015 Sep;41(9):1571-5. doi: 10.1016/j.joen.2015.04.022. Epub 2015 Jun 10.
    Results Reference
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    Evaluation of Survival of Mature Second Premolar Treated With Regenerative Techniques

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