Three Dimensional Evaluation of Apexogenesis of Immature Young Permanent Teeth With Different Endodontic Material

March 17, 2023 updated by: Alaa M Eldehna, Al-Azhar University

Three Dimensional Evaluation of Apexogenesis of Immature Young Permanent Teeth With Different Endodontic Tri-calcium Silicate-Based Putties: Randomized Clinical Trial

Randomized Clinical Trial using Three Dimensional Evaluation of Apexogensis of immature young permanent teeth with Different Endodontic Tri-calcium Silicate-Based Putties

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Treatment of immature permanent teeth has always been challenging in endodontics, not only because of their wide-open root apices but also because of the thin underdeveloped dentinal walls.Apexogenesis falls under the category of vital pulp therapy (VPT) procedure to maintain pulp vitality, induce dentin bridge formation and encourage continued root maturation.

To overcome the drawbacks of tricalcium silicate-based cements, a range of bioactive endodontic cements have been developed.

EndoSequence BC RRM-Fast Set Putty and NeoPutty (NuSmile, Houston, TX, USA) are the two materials evaluated in this study.

Study Type

Interventional

Enrollment (Anticipated)

48

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 Contact

Study Locations

  • Egypt
    • Choose A State Or Province
      • Cairo, Choose A State Or Province, Egypt, 00040
        • Recruiting
        • Al-Azhar university dental clinics and 6 October university dental clinics
        • Contact:

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

6 years to 9 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • First permanent molar with pulpitis.
  • Sufficient tooth structure for placing rubber dam.
  • Presence of open apex.
  • Short root length.

Exclusion Criteria:

  • Insufficient tooth structure that need post and core.
  • Presence of swelling.
  • Presence of sinus tract.
  • Presence of root fracture.
  • Presence of root crack.
  • Presence of external or internal root resorption.
  • Presence of periapical pathosis.
  • Presence of root calcification.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group (I) control
young permanent pulpy exposed carious tooth of the selected participants will be treated with specific technique called apexogenesis using bio-compatible material (endo-sequence putty ). This material is administrated to the tooth by placing about 2-4 mm bulk of material in the pulp champers at the cervical line then sealing the capping material with glass ionomer and stainless steel crown.
Procedure: endo-sequence putty
pupal medicament which is materials used in case of vital pulp therapy (VPT) procedure after opening access in the inflamed pulp to maintain it is vitality, inducing dentin bridge formation and encourage continued root maturation.
Other Names:
  • Endodontic Tri-calcium Silicate-Based Puty
Experimental: Group (II)
young permanent pulpy exposed carious tooth of the selected participants will be treated with specific technique called apexogenesis using bio-compatible material (neo-MTA putty). This material is administrated to the tooth by placing about 2-4 mm bulk of material in the pulp champers at the cervical line then sealing the capping material with glass ionomer and stainless steel crown.
Procedure: neo-MTA putty
pupal medicament which is materials used in case of vital pulp therapy (VPT) procedure after opening access in the inflamed pulp to maintain it is vitality, inducing dentin bridge formation and encourage continued root maturation.
Other Names:
  • Endodontic Tri-calcium Silicate-Based Puty

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
asymptomatic
Time Frame: one year
pain relief after procedure by Numeric rating scales on follow up visits.Most pain scales use numbers from 0 to 10. A score of 0 means no pain, and 10 means the worst pain you have ever felt.
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
complete root maturation
Time Frame: one year
increasing the length the root till the apex closure which is determined by cone beam analysis
one year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
maintain pulp vitality
Time Frame: one year
Positive response to sensibility testing. it evaluates the condition of the Pulp Being Very Responsive to a hot and cold Stimulus The pulp is deemed normal when there is a response to the stimulus. Pulpitis is present when there is an exaggerated response that produces pain. The absence of responses to sensibility tests is usually associated with the likelihood of pulp necrosis, the tooth is pulpless,
one year

Collaborators and Investigators

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

Sponsor

Al-Azhar University

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 8, 2022

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

May 1, 2024

Study Registration Dates

First Submitted

February 1, 2023

First Submitted That Met QC Criteria

March 17, 2023

First Posted (Actual)

March 30, 2023

Study Record Updates

Last Update Posted (Actual)

March 30, 2023

Last Update Submitted That Met QC Criteria

March 17, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-PD-22-26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Three Dimensional Evaluation of Apexogenesis of immature young permanent teeth with Different Endodontic Tri-calcium Silicate-Based Putties: Randomized Clinical Trial

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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