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Use of Mineral Trioxide Aggregate in the Treatment of Traumatized Teeth

Primary Purpose

Periapical Diseases

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
ProRoot MTA
MTA+ Cerkamed
Sponsored by
Association of Paediatric and Preventive Dentists of Serbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periapical Diseases focused on measuring periapical diseases, dental injuries, MTA

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Healthy patient
  • Non-vital tooth with chronic periapical lesions
  • Restorable tooth
  • No horizontal or vertical root fractures
  • No root resorption

Exclusion Criteria:

  • Unrestorable tooth
  • Horizontal or vertical root fractures
  • Root resorption

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    ProRoot MTA

    MTA+ Cercamed

    Arm Description

    Traumatized permanent teeth obturated with ProRoot MTA after root canal treatment

    Traumatized permanent teeth obturated with MTA+ Cerkamed after root canal treatment

    Outcomes

    Primary Outcome Measures

    Changes Between Initial and Post Treatment Dimensions of Periapical Lesions
    Changes in the dimensions of periapical lesions will be performed according to the analysis of initial and post treatment radiographs (baseline, 3, 6, 12, and 24-months subsequent to obturation) after being photographed using a digital camera Kodak EasyShare Max (Z990) with millimetre measurer in order to obtain interpretation of sizes of periapical lesions during conversion of pixels in mm2 by digital data processing in Adobe Photoshop CS software. Sucessful radiographic assessment will include decrease in size of the periapical lesion at the recall time of 24 months.

    Secondary Outcome Measures

    Presence of Clinical Symptoms
    Clinical examination will be used to assess the presence of spontaneous or provoked pain, discomfort during chewing, numbness or tenderness to percussion and/or palpation, altered tooth mobility, tooth crown discoloration or abscess and/or sinus tract.

    Full Information

    First Posted
    December 1, 2015
    Last Updated
    August 30, 2017
    Sponsor
    Association of Paediatric and Preventive Dentists of Serbia
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02625298
    Brief Title
    Use of Mineral Trioxide Aggregate in the Treatment of Traumatized Teeth
    Official Title
    Use of Mineral Trioxide Aggregate in the Treatment of Traumatized Permanent Teeth With Necrotic Pulps and Chronic Periapical Lesions
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2010 (undefined)
    Primary Completion Date
    December 2015 (Actual)
    Study Completion Date
    March 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Association of Paediatric and Preventive Dentists of Serbia

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Traumatic tooth injuries are common in children and adolescents, and often result in pulpal necrosis and the development of periapical lesions. Treatment of traumatized teeth with endodontic complications depends on the type of injury, number of injured teeth, root development and patient cooperation, which altogether will create a challenge and dictate the treatment plan for the dentist. The purpose of this study was to assess the effectiveness of non-surgical root canal procedures in traumatized permanent teeth with necrotic pulps and chronic periapical lesions using a tri-antibiotic paste and calcium-hydroxide as intracanal medications and two different mineral trioxide aggregate (MTA) products for definitive obturation.
    Detailed Description
    Root canal procedures will be performed on single-rooted traumatized permanent teeth (both with mature and immature root development) with necrotic pulps and periaoical lesions. Following access opening in each tooth, the root canals will be gently debrided with a crown-down manual technique using K-files according to the radiographically determined working lengths; irrigation with saline was used in all cases. K-files will be only used to remove the necrotic tissue and the softened predentinal layer without excessive removal of mineralized dentin, as this may have further weaken already thin walls of the root canals, particularly those with immature apical development. Subsequently, a reshaping of the canal system, followed by a minor curettage of the periapical area through the canal using barbed broaches will be made in order to partially destruct the periapical lesion and provoke bleeding. Final irrigation will be performed using 2% NaOCl (Chloraxid, Cerkamed, Stalowa Wola-Poland), 0.2% solution of chlorhexidine-digluconate (Curasept 220, Curadent Swiss GmbH, Kriens-Switzerland) and 40% citric acid solution (40% Citric acid, Cerkamed, Stalowa Wola, Poland). The canals will be then dried with sterile paper points and filled with triple-antibiotics paste using a lentula, for a period of seven days. Following this initial disinfection, calcium-hydroxide paste will be placed into the root canals for at least four weeks, for a maximum of six weeks (UltraCal XS, Ultradent Products Inc., South Jordan, UT USA). Apical thirds of the root canals will be obturated either with ProRoot MTA (Dentsply Tulsa Dental Specialties, Tulsa, OK USA) or MTA+ Cerkamed (Cerkamed, Stalowa Wola, Poland) by forming an apical plug of 3-5 mm of thickness. The correct placement of the apical plug will be assessed radiographically, and the moist cotton pellet was left in the root canal. The next day, the rest of the canal space will be filled with a sealer (Acroseal, Septodont, Saint-Maur des Frosses-France) and gutta-percha points (Guttapercha, VDW GmbH, Munich-Germany) using a lateral compaction technique. Coronal parts of root canal systems will be sealed using glass-ionomer cement (Fuji IX, GC Int., Tokyo, Japan) with a minimum thickness of 1.5-2 mm. The teeth will be restored using composite material (Gradia Direct, GC Int., Tokyo, Japan). Two dentists with many years of clinical experience, and using identical, predetermined treatment protocols will perform all treatments. The positive clinical outcome will comprise of absence of spontaneous or provoked pain, no discomfort during chewing, no numbness or tenderness to percussion and/or palpation, no altered tooth mobility, tooth crown discoloration or abscess and/or sinus tract. Radiological assessment of the outcomes will be performed according to the analysis of post treatment radiographs (initial, baseline, 3, 6, 12, and 24-months subsequent to obturation) after being photographed using a digital camera Kodak EasyShare Max (Z990) with millimetre measurer in order to obtain interpretation of sizes of periapical lesions during conversion of pixels in mm2 by digital data processing in Adobe Photoshop CS software.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Periapical Diseases
    Keywords
    periapical diseases, dental injuries, MTA

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    24 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ProRoot MTA
    Arm Type
    Experimental
    Arm Description
    Traumatized permanent teeth obturated with ProRoot MTA after root canal treatment
    Arm Title
    MTA+ Cercamed
    Arm Type
    Experimental
    Arm Description
    Traumatized permanent teeth obturated with MTA+ Cerkamed after root canal treatment
    Intervention Type
    Device
    Intervention Name(s)
    ProRoot MTA
    Intervention Description
    Apical thirds of the root canals obturated with ProRoot MTA (Dentsply Tulsa Dental Specialties, Tulsa, OK USA).
    Intervention Type
    Device
    Intervention Name(s)
    MTA+ Cerkamed
    Intervention Description
    Apical thirds of the root canals obturated with MTA + (Cerkamed, Stalowa Wola, Poland).
    Primary Outcome Measure Information:
    Title
    Changes Between Initial and Post Treatment Dimensions of Periapical Lesions
    Description
    Changes in the dimensions of periapical lesions will be performed according to the analysis of initial and post treatment radiographs (baseline, 3, 6, 12, and 24-months subsequent to obturation) after being photographed using a digital camera Kodak EasyShare Max (Z990) with millimetre measurer in order to obtain interpretation of sizes of periapical lesions during conversion of pixels in mm2 by digital data processing in Adobe Photoshop CS software. Sucessful radiographic assessment will include decrease in size of the periapical lesion at the recall time of 24 months.
    Time Frame
    baseline, 3, 6, 12 and 24 months
    Secondary Outcome Measure Information:
    Title
    Presence of Clinical Symptoms
    Description
    Clinical examination will be used to assess the presence of spontaneous or provoked pain, discomfort during chewing, numbness or tenderness to percussion and/or palpation, altered tooth mobility, tooth crown discoloration or abscess and/or sinus tract.
    Time Frame
    baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    7 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Healthy patient Non-vital tooth with chronic periapical lesions Restorable tooth No horizontal or vertical root fractures No root resorption Exclusion Criteria: Unrestorable tooth Horizontal or vertical root fractures Root resorption

    12. IPD Sharing Statement

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    Use of Mineral Trioxide Aggregate in the Treatment of Traumatized Teeth

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