Magnetic Resonance Imaging (MRI) of Pulp Regeneration

NCT ID: NCT03804450

Last Updated: 2019-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2018-12-28

Brief Summary

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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

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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.

Conditions

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Pulp Necroses Periapical Lesion Regeneration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type EXPERIMENTAL

Regenerative endodontic procedures (REPs)

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Regenerative endodontic procedures (REPs)

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Pulp Regeneration

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Noha Mohamed El Kateb

Assistant lecturer, Faculty of dentistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Alexandria University

Alexandria, , Egypt

Site Status

Countries

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Egypt

References

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El-Kateb NM, Abdallah AM, ElBackly RN. Correlation between pulp sensibility and magnetic resonance signal intensity following regenerative endodontic procedures in mature necrotic teeth- a retrospective cohort study. BMC Oral Health. 2024 Mar 13;24(1):330. doi: 10.1186/s12903-024-04095-y.

Reference Type DERIVED
PMID: 38481211 (View on PubMed)

Other Identifiers

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15012017

Identifier Type: -

Identifier Source: org_study_id

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