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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03804450
Other study ID # 15012017
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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

Study Design


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
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