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Magnetic Resonance Imaging (MRI) of Pulp Regeneration

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ClinicalTrials.gov Identifier: NCT03804450
Recruitment Status : Completed
First Posted : January 15, 2019
Last Update Posted : January 17, 2019
Sponsor:
Information provided by (Responsible Party):
Noha Mohamed El Kateb, Alexandria University

Study Description
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Brief Summary:
The present study was conducted to test whether pulp-like tissue can be regenerated in mature teeth with closed apex? And whether the size of the apical diameter affects the success of REPs? And whether Magnetic resonance imaging (MRI) can be used to quantitatively assess the vitality of the regenerated pulp-like tissue.

Condition or disease Intervention/treatment Phase
Pulp Necroses Periapical Lesion Regeneration Procedure: Regenerative endodontic procedures (REPs) Phase 2

Detailed Description:

Regenerative endodontic procedures via blood clot were done on 18 mature anterior necrotic teeth with periapical lesions. The teeth were randomly assigned into two groups according to the size of the apical diameter of the rotary files used for instrumentation.

In the test group, rotary instrumentation was done using Pro-taper Next till size X3, while in the control group, instrumentation was done till size X5.

Calcium hydroxide was used as an intracanal medication for 1-2 weeks. Calcium hydroxide was then washed away using 1.5%NaOCl, followed by induction of blood using pre-curved K-fi;e #25 2mm past the radiographic apex. Biodentine was then used as a cervical plug over the blood clot followed by resin-modified glass ionomer cement and composite resin as coronal restoration.

MRI was used to assess the vitality of the regenerated pulp-like tissue, where the signal intensity of the regenerated pulp-like tissue was measured after 3,6 and 12 months follow up and compared to the normal contralateral teeth. In addition, sensibility tests using cold test and electric pulp testing were used to assess vitality of regenerated pulp-like tissue after 3,6,9 and 12 months. Cone beam computed tomography (CBCT) was also used to assess the healing of the periapical lesion after 12 months.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Magnetic Resonance Imaging Assessment of Pulp Regeneration Following Regenerative Endodontic Procedures in Mature Teeth
Actual Study Start Date : July 1, 2017
Actual Primary Completion Date : September 3, 2018
Actual Study Completion Date : December 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arms and Interventions
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Arm Intervention/treatment
Experimental: Test group
The root canals were instrumented using Pro-taper next rotary files till size X3. REPs via blood clot using calcium hydroxide were then applied
 Procedure: Regenerative endodontic procedures (REPs)
Instrumentation using rotary Pro-Taper Next, disinfection using sodium hypochlorite and calcium hydroxide as intracanal medication followed by induction of blood and application of Biodentine as a cervical plug.
Other Name: Pulp Regeneration
Experimental: Control group
The root canals were instrumented using Pro-taper next rotary files till size X5. REPs via blood clot using calcium hydroxide were then applied.
 Procedure: Regenerative endodontic procedures (REPs)
Instrumentation using rotary Pro-Taper Next, disinfection using sodium hypochlorite and calcium hydroxide as intracanal medication followed by induction of blood and application of Biodentine as a cervical plug.
Other Name: Pulp Regeneration


Outcome Measures
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Primary Outcome Measures :
  1. MRI assessment of pulp-like tissue regeneration [ Time Frame: 12 months ]
    Signal intensity of the regenerated pulp-like tissue was quantitatively measured in both test and control groups after 3,6 and 12 months follow up and compared to the contralateral normal teeth.


Secondary Outcome Measures :
  1. Healing of the periapical lesion [ Time Frame: 12 months ]
    Cone beam computed tomography (CBCT) was used to assess the healing of the periapical lesion after 12 months follow up period.

  2. Positive pulpal response [ Time Frame: 12 months ]
    The positive response to sensibility tests using cold test and electric pulp tester was done after 3,6,9 and 12 months


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Upper anterior mature teeth with single canals.
  • Necrotic teeth
  • Presence of periapical lesion.

Exclusion Criteria:

  • Presence of systemic diseases.
  • Presence of stainless steel wires o brackets
  • Vital immature teeth with open apex
Contacts and Locations
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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): NCT03804450


Locations
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Egypt
Alexandria University
Alexandria, Egypt
Sponsors and Collaborators
Alexandria University
More Information
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Responsible Party: Noha Mohamed El Kateb, Assistant lecturer, Faculty of dentistry, Alexandria University
ClinicalTrials.gov Identifier: NCT03804450    
Other Study ID Numbers: 15012017
First Posted: January 15, 2019    Key Record Dates
Last Update Posted: January 17, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Noha Mohamed El Kateb, Alexandria University:
Mature teeth
Necrotic teeth
REPs
 Biodentine
MRI
CBCT
Additional relevant MeSH terms:
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Dental Pulp Necrosis
Necrosis
Pathologic Processes
 Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases