Magnetic Resonance Imaging (MRI) of Pulp Regeneration

Sponsor

Alexandria University (Other)

Overall Status

Completed

CT.gov ID

NCT03804450

Collaborator

(none)

Enrollment

Location

Arms

17.9

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

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

Study Type:

Interventional

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 :

Jul 1, 2017

Actual Primary Completion Date :

Sep 3, 2018

Actual Study Completion Date :

Dec 28, 2018

Arms and Interventions

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

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)

Other Names:

Pulp Regeneration

Outcome Measures

Primary Outcome Measures

MRI assessment of pulp-like tissue regeneration [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

Healing of the periapical lesion [12 months]
Cone beam computed tomography (CBCT) was used to assess the healing of the periapical lesion after 12 months follow up period.
Positive pulpal response [12 months]
The positive response to sensibility tests using cold test and electric pulp tester was done after 3,6,9 and 12 months