NCT03804450

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2017

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 28, 2018

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

January 7, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 15, 2019

Completed
Last Updated

January 17, 2019

Status Verified

January 1, 2019

Enrollment Period

1.2 years

First QC Date

January 7, 2019

Last Update Submit

January 15, 2019

Conditions

Keywords

Mature teethNecrotic teethREPsBiodentineMRICBCT

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Healing of the periapical lesion

    12 months

  • Positive pulpal response

    12 months

Study Arms (2)

Test group

EXPERIMENTAL

The root canals were instrumented using Pro-taper next rotary files till size X3. REPs via blood clot using calcium hydroxide were then applied

Procedure: Regenerative endodontic procedures (REPs)

Control group

EXPERIMENTAL

The root canals were instrumented using Pro-taper next rotary files till size X5. REPs via blood clot using calcium hydroxide were then applied.

Procedure: Regenerative endodontic procedures (REPs)

Interventions

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.

Also known as: Pulp Regeneration
Control groupTest group

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Upper anterior mature teeth with single canals.
  • Necrotic teeth
  • Presence of periapical lesion.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alexandria University

Alexandria, Egypt

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Dental Pulp Necrosis

Condition Hierarchy (Ancestors)

Dental Pulp DiseasesTooth DiseasesStomatognathic DiseasesNecrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer, Faculty of dentistry

Study Record Dates

First Submitted

January 7, 2019

First Posted

January 15, 2019

Study Start

July 1, 2017

Primary Completion

September 3, 2018

Study Completion

December 28, 2018

Last Updated

January 17, 2019

Record last verified: 2019-01

Locations