Magnetic Resonance Imaging (MRI) of Pulp Regeneration

Phase 2

Completed

• Conditions: Pulp Necroses; Regeneration; Periapical Lesion
• Interventions: Procedure: Regenerative endodontic procedures (REPs)

• Registration Number: NCT03804450
• Lead Sponsor: Alexandria University

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.

Study Timeline

• Study Start: 2017-07-01
• Primary Completion: 2018-09-03
• Study Completion: 2018-12-28
• Status Verified: 2019-01
• Study First Submitted: 2019-01-07
• Study First Submitted QC: 2019-01-11
• Study First Posted: 2019-01-15
• Last Update Submitted: 2019-01-15
• Last Update Posted: 2019-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

• Presence of systemic diseases.
• Presence of stainless steel wires o brackets
• Vital immature teeth with open apex

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Regenerative endodontic procedures (REPs)	The root canals were instrumented using Pro-taper next rotary files till size X5. REPs via blood clot using calcium hydroxide were then applied.
Test group	Regenerative endodontic procedures (REPs)	The root canals were instrumented using Pro-taper next rotary files till size X3. REPs via blood clot using calcium hydroxide were then applied

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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
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.

Trial Locations

Locations (1)

Alexandria University; 🇪🇬 Alexandria, Egypt