Magnetic Resonance Imaging (MRI) of Pulp Regeneration

Pulp Necroses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03804450
• Other study ID #: 15012017
• Status: Completed
• Phase: Phase 2
• Start date: July 1, 2017
• Est. completion date: December 28, 2018

Study information

• Verified date: January 2019
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: December 28, 2018
• Est. primary completion date: September 3, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Pulp Necrosis
• Necrosis
• Periapical Lesion
• Pulp Necroses
• Regeneration

Intervention

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.

Locations

Country	Name	City	State
Egypt	Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Secondary	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.	12 months
Secondary	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	12 months