Magnetic Resonance Imaging (MRI) of Pulp Regeneration

January 15, 2019 updated by: Noha Mohamed El Kateb, Alexandria University

Magnetic Resonance Imaging Assessment of Pulp Regeneration Following Regenerative Endodontic Procedures in Mature Teeth

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

18

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Alexandria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Pulp Regeneration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2017

Primary Completion (ACTUAL)

September 3, 2018

Study Completion (ACTUAL)

December 28, 2018

Study Registration Dates

First Submitted

January 7, 2019

First Submitted That Met QC Criteria

January 11, 2019

First Posted (ACTUAL)

January 15, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 17, 2019

Last Update Submitted That Met QC Criteria

January 15, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15012017

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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