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Completed

NCT Number: NCT03804450

Magnetic Resonance Imaging (MRI) of Pulp Regeneration

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.

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Key information

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Alexandria University

Alexandria, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Regenerative endodontic procedures (REPs)

Procedure

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jan 15, 2019
Registry last updated
Jan 17, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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