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Revascularization of Immature Anterior Necrotic Teeth

Primary Purpose

Pulp Necroses

Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
intracanal disinfection in revascularization
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulp Necroses focused on measuring immature teeth, revascularization

Eligibility Criteria

7 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Immature anterior teeth with open apices.
  • Necrotic teeth (regardless the cause of pulpal involvement: Caries, trauma or congenital anomalies).
  • Children free from any systemic diseases that may interfere with the normal healing process.

Exclusion Criteria:

  • Children Allergic to antibiotics to be used in the study.
  • unooperative children.
  • Laxative injuries.
  • Compromised remaining tooth structure.
  • internal or external root resorption

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Calcium Hydroxide in revascularization

    Di-antibiotic paste in revascularization

    Arm Description

    Revascularization of necrotic anterior teeth: canals disinfection step. Pure Calcium Hydroxide powder mixed with saline will be placed as intra-canal medication in the 1st visit of dental pulp revascularization.

    Revascularization of necrotic anterior teeth: canals disinfection step. Mix 1:1 ciprofloxacin: metronidazole to a final concentration of 0.1 mg/ml, placed as intra-canal medication in the 1st visit of dental pulp revascularization.

    Outcomes

    Primary Outcome Measures

    Pain
    Binary outcome (present/ absent). Assessed by asking the patient
    Change in pain
    Binary outcome (present/ absent). Assessed by asking the patient.

    Secondary Outcome Measures

    Pain on percussion
    Binary outcome (present/absent).Assessed by using back of the dental mirror.
    Swelling
    Binary outcome (present/absent). Assessed by visual inspection of labial vestibules.
    Sinus or fistula
    Binary outcome (present/absent). Assessed by visual inspection of labial vestibules.
    Root Lengthening
    Will be evaluated radiographically using DIGORA software. Unit of measurement will be mm.

    Full Information

    First Posted
    April 5, 2018
    Last Updated
    April 12, 2018
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03504332
    Brief Title
    Revascularization of Immature Anterior Necrotic Teeth
    Official Title
    Clinical and Radiographic Evaluation of Calcium Hydroxide and Bi-antibiotic Paste as Anti-microbial Dressing in Revascularization of Non Vital Immature Permanent Anterior Teeth: A Randomized Clinical Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 2018 (Anticipated)
    Primary Completion Date
    June 2020 (Anticipated)
    Study Completion Date
    September 2020 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The object of this study is to compare the effect of Calcium Hydroxide and Di-antibiotic paste as intracanal disinfectants in the 1st visit of revascularization of necrotic immature permanent anterior teeth.
    Detailed Description
    Dental trauma is common in children and it is the main cause of loss of pulp vitality in immature permanent anterior teeth with prevalence rate of 11% and about of 27% of traumatized anterior teeth are left untreated. Dentists face many challenges during the treatment of infected immature permanent teeth. This is mainly due to the thin dentinal walls of the root and blunderbuss apices that make these teeth susceptible to fracture during and after treatment. Traditionally, Calcium Hydroxide apexification has been the only method for managing these cases.. however, it was found that this technique caused additional reduction in root strength due to the long-term application of Calcium Hydroxide which may end in fracture of the tooth. The time needed for complete apexification using Calcium Hydroxide was reported to be variable ranging from 5 to 20 months, with failure rate 0f 30% . Therefore, this technique is no longer recommended for the treatment of such cases. A recently proposed technique for the treatment of immature necrotic permanent teeth is revascularization regenerative endodontic therapy (RET). It is a biologically based technique that allow the continuation of root development and thickening of dentinal walls. This is achieved through proper disinfection o the root canal system, creation of scaffold and perfect coronal seal. For proper disinfection of the root canal system, antibiotic paste was applied as intracanal dressing for 2-3 weeks. However, the recent recommendations by the European society of Endodontology advices the use of Calcium Hydroxide as intracanal medication instead of intracanal antibiotics. This is because of some concerns regarding the use of antibiotics which include: cytotoxicity to stem cells needed for the revascularization process, risk of antibiotic resistance and the risk of sensitization. Calcium Hydroxide on the other hand is widely used as intracanal disinfectant and some studies were found supporting its use in the revascularization technique, [9, 10]. However, the data available is not sufficient regarding the effectiveness of Calcium Hydroxide in revascularization of necrotic pulp. Besides, more trials are needed to evaluate the clinical effectiveness of RET in management of immature necrotic permanent teeth as the evidence of using this technique is still weak.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulp Necroses
    Keywords
    immature teeth, revascularization

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    56 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Calcium Hydroxide in revascularization
    Arm Type
    Experimental
    Arm Description
    Revascularization of necrotic anterior teeth: canals disinfection step. Pure Calcium Hydroxide powder mixed with saline will be placed as intra-canal medication in the 1st visit of dental pulp revascularization.
    Arm Title
    Di-antibiotic paste in revascularization
    Arm Type
    Active Comparator
    Arm Description
    Revascularization of necrotic anterior teeth: canals disinfection step. Mix 1:1 ciprofloxacin: metronidazole to a final concentration of 0.1 mg/ml, placed as intra-canal medication in the 1st visit of dental pulp revascularization.
    Intervention Type
    Procedure
    Intervention Name(s)
    intracanal disinfection in revascularization
    Intervention Description
    a procedure to create vital cells in the pulp space of immature teeth which enables thickening of the dentinal walls of the root.
    Primary Outcome Measure Information:
    Title
    Pain
    Description
    Binary outcome (present/ absent). Assessed by asking the patient
    Time Frame
    baseline.
    Title
    Change in pain
    Description
    Binary outcome (present/ absent). Assessed by asking the patient.
    Time Frame
    at 6 and 12 months
    Secondary Outcome Measure Information:
    Title
    Pain on percussion
    Description
    Binary outcome (present/absent).Assessed by using back of the dental mirror.
    Time Frame
    baseline and for 1 year follow up
    Title
    Swelling
    Description
    Binary outcome (present/absent). Assessed by visual inspection of labial vestibules.
    Time Frame
    baseline and for 1 year follow up
    Title
    Sinus or fistula
    Description
    Binary outcome (present/absent). Assessed by visual inspection of labial vestibules.
    Time Frame
    baseline and for 1 year follow up
    Title
    Root Lengthening
    Description
    Will be evaluated radiographically using DIGORA software. Unit of measurement will be mm.
    Time Frame
    baseline and for 1 year follow up

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    15 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Immature anterior teeth with open apices. Necrotic teeth (regardless the cause of pulpal involvement: Caries, trauma or congenital anomalies). Children free from any systemic diseases that may interfere with the normal healing process. Exclusion Criteria: Children Allergic to antibiotics to be used in the study. unooperative children. Laxative injuries. Compromised remaining tooth structure. internal or external root resorption
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Reem Wahby, MD
    Phone
    0020112652778
    Email
    reem.wahby@dentistry.cu.edu.eg

    12. IPD Sharing Statement

    Learn more about this trial

    Revascularization of Immature Anterior Necrotic Teeth

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