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Evaluation the Effect of Using of Apical Matrix With Apexification Procedure on Apical Healing of Necrotic Immature Teeth

Primary Purpose

Pulp Necrosis, Apexification

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Apexification
MTA
Ca(OH)2
Apical matrix
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulp Necrosis focused on measuring Open apex, Immature teeth, Non vital pulp, Apical plug, Internal matrix

Eligibility Criteria

8 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Immature permanent maxillary anterior teeth
  • Non vital pulp
  • 6-18 years old
  • Half or more root length developed Restorable
  • No internal or external root resorption
  • No horizontal or vertical root fractures
  • Fit and healthy patient

Exclusion Criteria:

  • Mature
  • Vital pulp
  • <6 ,>18 years old
  • Less than half of the root developed
  • Non - restorable
  • Root resorption
  • Horizontal or vertical root fractures
  • Patients with history of uncontrolled diabetes, immunosuppression, severe asthma Patients suffering from periodontal disease

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Active Comparator

    Experimental

    Active Comparator

    Experimental

    Arm Label

    Ca(OH)2 Apexification

    Ca(OH)2 Apexification with apical matrix

    MTA Apexification

    MTA Apexification with apical matrix

    Arm Description

    Apexification was performed with calcium hydroxide. calcium hydroxide dressing was applied directly against the open apex .The canals were back filled with Ca(OH)2 dressing, followed by proper coronal seal. Patients were recalled every 3, 6 and 12 months for evaluation clinically and radiographically. Once the calcific apical barrier was detected the root canals were then obturated and final restoration was done.

    Treated by condensation of calcium hydroxide dressing against an internal matrix , a piece (4X4mm) of resorbable collagen membrane (Biocollagen; Bioteck:Turin, Italy) was gently compacted toward the apex before insertion of Ca(OH)2 dressing, followed by proper coronal seal. Patients were recalled every 3, 6 and 12 months for evaluation clinically and radiographically. Once the calcific apical barrier was detected the root canals were then obturated and final restoration was done.

    Apexification was performed with MTA as apical plug. A 3-5 mm thickness of MTA using a hand plugger was applied as apical plug and verified radiographically. Moist cotton pellet was placed over the MTA followed by application of coronal seal. After 48 h, the set of the MTA was checked and final obturation of the root canal was done

    An internal (apical) matrix was used as a base for condensation of MTA apical plug, a pieces of (4X4mm) of resorbable collagen membrane (Biocollagen; Bioteck:Turin, Italy)were compacted toward the apex with premeasured suitable size schilder plugger. Moist cotton pellet was placed over the MTA followed by application of coronal seal. After 48 h, the set of the MTA was checked and final obturation of the root canal was done

    Outcomes

    Primary Outcome Measures

    Change in pain on percussion
    Assessed by tapping the tooth with the back of the mirror (Present or absent) binary outcome
    Change in swelling and/or sinus
    Assessed by visual examination of labial vestibule.The presence of swelling or sinus reported by a binary question yes/no
    Change in periapical pathosis
    Change in periapical bone density on follow up radiographs to assess the healing process

    Secondary Outcome Measures

    presence of a calcified apical barrier or not
    Teeth will be reviewed clinically and radiographically in order to detect the calcific barrier formation
    Periapical Lesion scored with periapical index ( PAI)
    Radio graphically The periapical index provides an ordinal scale of 5 scores ranging from ''healthy'' to ''severe periodontitis with exacerbating features''. (1) Normal periapical structures. (2) Small changes in bone structure. (3) Changes in bone structure with some diffuse mineral loss.(4) Periodontitis with well-defined radiolucent area. (5) Severe periodontitis with exacerbating features. (1, 2: healthy and 3, 4, 5: pathological).baseline, 3 months, 6 months, and 12 months

    Full Information

    First Posted
    January 4, 2019
    Last Updated
    February 20, 2019
    Sponsor
    Al-Azhar University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03849222
    Brief Title
    Evaluation the Effect of Using of Apical Matrix With Apexification Procedure on Apical Healing of Necrotic Immature Teeth
    Official Title
    Enhancement of Apexification Procedure Outcome of Non Vital Incompletely Formed Roots Using Apical Matrix
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    August 20, 2013 (Actual)
    Primary Completion Date
    April 20, 2016 (Actual)
    Study Completion Date
    September 1, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Al-Azhar University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This study was conducted to evaluate the effect of the use of apical matrix, with Mineral Trioxide Aggregate (MTA) or calcium hydroxide Ca(OH)2 Apexification on apical healing and calcific barrier formation of immature teeth with non- vital pulp.
    Detailed Description
    Conventional root canal filling procedures are challenging in cases of teeth with necrotic pulp, immature apices, and periapical lesions because of the absence of natural apical constriction and the presence of moisture contamination. In these cases, the risk of extrusion of the root filling materials and the difficulty in managing apical seals compromise the long-term outcome of treatment. Management of immature teeth with non-vital pulp were confined to custom fitting the filling material, paste fills and apical surgery. The limited success enjoyed by these procedures resulted in significant interest in the phenomenon of establishment of an apical barrier like apexification or continued apical development. Apexification defined as a procedure to induce a calcified barrier in a root with an open apex and necrotic pulp Traditionally, the most commonly used material for apexification is Ca(OH)2 .Despite the high success rate of The long-term Ca(OH)2 apexification , there are several disadvantages to this technique; Length of time for induction of apical hard tissue barriers. Incomplete apical hard tissue barriers because of vascular inclusions.To avoid the challenges associated with long-term Ca(OH)2 apexification procedures, a non-surgical, one-step apexification using MTA as apical plug. The major problem in cases of a wide open apex is the need to limit the apexification material at the apex, thus avoiding the extrusion of a large amount of material into the periodontal tissue. The use of a matrix is advisable since its placement in the area of bone destruction provides a base on which the sealing material can be packed . This randomized controlled trial study was carried out to compare the clinical and radiographic outcome of Ca(OH)2 and MTA with or without internal matrix in non-vital immature maxillary incisors.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Pulp Necrosis, Apexification
    Keywords
    Open apex, Immature teeth, Non vital pulp, Apical plug, Internal matrix

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2, Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    participants are allocated at random to receive one of 4 interventions according to the research plan.
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    32 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ca(OH)2 Apexification
    Arm Type
    Active Comparator
    Arm Description
    Apexification was performed with calcium hydroxide. calcium hydroxide dressing was applied directly against the open apex .The canals were back filled with Ca(OH)2 dressing, followed by proper coronal seal. Patients were recalled every 3, 6 and 12 months for evaluation clinically and radiographically. Once the calcific apical barrier was detected the root canals were then obturated and final restoration was done.
    Arm Title
    Ca(OH)2 Apexification with apical matrix
    Arm Type
    Experimental
    Arm Description
    Treated by condensation of calcium hydroxide dressing against an internal matrix , a piece (4X4mm) of resorbable collagen membrane (Biocollagen; Bioteck:Turin, Italy) was gently compacted toward the apex before insertion of Ca(OH)2 dressing, followed by proper coronal seal. Patients were recalled every 3, 6 and 12 months for evaluation clinically and radiographically. Once the calcific apical barrier was detected the root canals were then obturated and final restoration was done.
    Arm Title
    MTA Apexification
    Arm Type
    Active Comparator
    Arm Description
    Apexification was performed with MTA as apical plug. A 3-5 mm thickness of MTA using a hand plugger was applied as apical plug and verified radiographically. Moist cotton pellet was placed over the MTA followed by application of coronal seal. After 48 h, the set of the MTA was checked and final obturation of the root canal was done
    Arm Title
    MTA Apexification with apical matrix
    Arm Type
    Experimental
    Arm Description
    An internal (apical) matrix was used as a base for condensation of MTA apical plug, a pieces of (4X4mm) of resorbable collagen membrane (Biocollagen; Bioteck:Turin, Italy)were compacted toward the apex with premeasured suitable size schilder plugger. Moist cotton pellet was placed over the MTA followed by application of coronal seal. After 48 h, the set of the MTA was checked and final obturation of the root canal was done
    Intervention Type
    Procedure
    Intervention Name(s)
    Apexification
    Intervention Type
    Drug
    Intervention Name(s)
    MTA
    Other Intervention Name(s)
    Proroot MTA
    Intervention Type
    Drug
    Intervention Name(s)
    Ca(OH)2
    Other Intervention Name(s)
    Ca(OH)2 dressing
    Intervention Type
    Drug
    Intervention Name(s)
    Apical matrix
    Other Intervention Name(s)
    internal matrix
    Intervention Description
    collagen membrane (Biocollagen; Bioteck:Turin, Italy)
    Primary Outcome Measure Information:
    Title
    Change in pain on percussion
    Description
    Assessed by tapping the tooth with the back of the mirror (Present or absent) binary outcome
    Time Frame
    baseline, 3 months, 6 months, and 12 months
    Title
    Change in swelling and/or sinus
    Description
    Assessed by visual examination of labial vestibule.The presence of swelling or sinus reported by a binary question yes/no
    Time Frame
    baseline, 3 months, 6 months, and 12 months
    Title
    Change in periapical pathosis
    Description
    Change in periapical bone density on follow up radiographs to assess the healing process
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    presence of a calcified apical barrier or not
    Description
    Teeth will be reviewed clinically and radiographically in order to detect the calcific barrier formation
    Time Frame
    3, 6 and 12 months
    Title
    Periapical Lesion scored with periapical index ( PAI)
    Description
    Radio graphically The periapical index provides an ordinal scale of 5 scores ranging from ''healthy'' to ''severe periodontitis with exacerbating features''. (1) Normal periapical structures. (2) Small changes in bone structure. (3) Changes in bone structure with some diffuse mineral loss.(4) Periodontitis with well-defined radiolucent area. (5) Severe periodontitis with exacerbating features. (1, 2: healthy and 3, 4, 5: pathological).baseline, 3 months, 6 months, and 12 months
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Immature permanent maxillary anterior teeth Non vital pulp 6-18 years old Half or more root length developed Restorable No internal or external root resorption No horizontal or vertical root fractures Fit and healthy patient Exclusion Criteria: Mature Vital pulp <6 ,>18 years old Less than half of the root developed Non - restorable Root resorption Horizontal or vertical root fractures Patients with history of uncontrolled diabetes, immunosuppression, severe asthma Patients suffering from periodontal disease
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mervat IB Fawzy, Professor
    Organizational Affiliation
    Professor of Endodontics AL-Azhar university
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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    Evaluation the Effect of Using of Apical Matrix With Apexification Procedure on Apical Healing of Necrotic Immature Teeth

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