Magnetic Resonance Imaging (MRI) of Pulp Regeneration
Primary Purpose
Pulp Necroses, Periapical Lesion, Regeneration
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Regenerative endodontic procedures (REPs)
Sponsored by
About this trial
This is an interventional treatment trial for Pulp Necroses focused on measuring Mature teeth, Necrotic teeth, REPs, Biodentine, MRI, CBCT
Eligibility 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
Sites / Locations
- Alexandria University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Test group
Control group
Arm Description
The root canals were instrumented using Pro-taper next rotary files till size X3. REPs via blood clot using calcium hydroxide were then applied
The root canals were instrumented using Pro-taper next rotary files till size X5. REPs via blood clot using calcium hydroxide were then applied.
Outcomes
Primary Outcome Measures
MRI assessment of pulp-like tissue regeneration
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
Healing of the periapical lesion
Cone beam computed tomography (CBCT) was used to assess the healing of the periapical lesion after 12 months follow up period.
Positive pulpal response
The positive response to sensibility tests using cold test and electric pulp tester was done after 3,6,9 and 12 months
Full Information
NCT ID
NCT03804450
First Posted
January 7, 2019
Last Updated
January 15, 2019
Sponsor
Alexandria University
1. Study Identification
Unique Protocol Identification Number
NCT03804450
Brief Title
Magnetic Resonance Imaging (MRI) of Pulp Regeneration
Official Title
Magnetic Resonance Imaging Assessment of Pulp Regeneration Following Regenerative Endodontic Procedures in Mature Teeth
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
September 3, 2018 (Actual)
Study Completion Date
December 28, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria 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 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulp Necroses, Periapical Lesion, Regeneration
Keywords
Mature teeth, Necrotic teeth, REPs, Biodentine, MRI, CBCT
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Test group
Arm Type
Experimental
Arm Description
The root canals were instrumented using Pro-taper next rotary files till size X3. REPs via blood clot using calcium hydroxide were then applied
Arm Title
Control group
Arm Type
Experimental
Arm Description
The root canals were instrumented using Pro-taper next rotary files till size X5. REPs via blood clot using calcium hydroxide were then applied.
Intervention Type
Procedure
Intervention Name(s)
Regenerative endodontic procedures (REPs)
Other Intervention Name(s)
Pulp Regeneration
Intervention Description
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.
Primary Outcome Measure Information:
Title
MRI assessment of pulp-like tissue regeneration
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Healing of the periapical lesion
Description
Cone beam computed tomography (CBCT) was used to assess the healing of the periapical lesion after 12 months follow up period.
Time Frame
12 months
Title
Positive pulpal response
Description
The positive response to sensibility tests using cold test and electric pulp tester was done after 3,6,9 and 12 months
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Alexandria University
City
Alexandria
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Magnetic Resonance Imaging (MRI) of Pulp Regeneration
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