Regenerative Endodontic Treatment of Mature Necrotic Teeth With Apical Periodontitis

January 21, 2024 updated by: Amatallah Hussein Nasser Al-Rawhani, Cairo University

Regenerative Root Canal Treatment of Mature Teeth With Pulp Necrosis and Apical Periodontitis Using Biodentine Compared With MTA: Randomized Clinical Double-blind Trial

The aim of this prospective, randomized, controlled double-blind study is to evaluate the effectiveness of biodentine compared with MTA used as pulp space barrier on discoloration of teeth after regenerative based non-obturation root canal treatment in mature single canal with pulp necrosis and apical periodontitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

• Regenerative endodontic treatment will be performed through two visits: First visit aims to clean and disinfect the tooth canal by copious irrigation with NaOCL and EDTA solution . At the end of first visit, canal will be dressed by CaOH as intracanal medicaments.

Second visit will be after two weeks. After removal of CaOH dressing by copius irrigation, evoking bleeding inside canal by over instrumentation. When blood become semi-coagulated, according to the random sequence number of the participants, either biodentine or white MTA will be placed as pulp space barrier.

At the end of treatment, the access cavity will be sealed with composite restoration.

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt
        • Dentistry Faculty

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 45 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Tooth type: single-rooted teeth (anterior or premolar) encasing of one root canal with mature root (closed apex).
  2. Negative response of pulp tissue to electrical or thermal pulp tester.
  3. Widening in lamina dura or periapical radiolucency not more than 3 mm.

Exclusion Criteria:

  • 1. Patients having significant systemic disorder or immunocompromised patients. 2. Teeth with generalized chronic periodontitis or have periodontal pocket larger than 3 mm.

    3. Teeth with developmental anomalies (i.e, dens invaginatusor a palatogingival groove).

    4. Teeth with previous root canal. 5. Teeth need to post and core as final restoration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Biodentine
Intervention group: application of biodentine as pulp space barrier during regenerative endodontic treatment.
Other: Biodentine
Biodentine is calcium silicate based cement which is bioactive and inductive material. Biodentine will be applied as coronal plug material.
Active Comparator: White MTA
Control group: application of White MTA as pulp space barrier during regenerative endodontic treatment.
Other: White MTA
MTA is calcium silicate based cement which is bioactive and inductive material. MTA is used in most cases of regenerative endodontics and it will be applied as coronal plug material.
Other Names:
  • white mineral trioxide aggregate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Discoloration of teeth
Time Frame: Up to one Year after completion of regenerative endodontic treatment
Discoloration of teeth that will be assessed clinically through follow up period 3, 6, 9, 12 months by visual examination and by using color shade guide (Tetric N shade guide, Ivoclar Vivadent) whether tooth discolored or not in comparison with the original preoperative color shade.
Up to one Year after completion of regenerative endodontic treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Healing of Periapical Tissue
Time Frame: after 3, 6,9 and Up to 12 months after completion of regenerative endodontic treatment
Healing of periapical tissue will be assessed clinically and radiographically through follow up period: 3, 6, 9, 12 months. When the case is clinically asymptomatic: (without sinus tract, swelling, with no palpation, or percussions pain) and radiographically showed absence or reduction of the radiolucency are together will considered successful of regenerative treatment.
after 3, 6,9 and Up to 12 months after completion of regenerative endodontic treatment
Restoring the sensibility of tooth
Time Frame: after 6,9 and Up to 12 months after completion of regenerative endodontic treatment
Electric pulp tester (EPT)
after 6,9 and Up to 12 months after completion of regenerative endodontic treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Amatallah HN Al-Rawhani, Master, Cairo University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Actual)

January 1, 2022

Study Completion (Actual)

June 1, 2023

Study Registration Dates

First Submitted

July 7, 2019

First Submitted That Met QC Criteria

July 11, 2019

First Posted (Actual)

July 12, 2019

Study Record Updates

Last Update Posted (Estimated)

January 23, 2024

Last Update Submitted That Met QC Criteria

January 21, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CU-2019-7-7

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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