A 24-month Outcomes of Single- Vs Multiple-visit Revascularization

January 6, 2025 updated by: Osama Seif El-Nasr Hussein Gad El-Hak, Minia University

Clinical and Radiographic Outcomes of Single- Versus Multiple-visit Revascularization of Asymptomatic Necrotic Immature Maxillary Permanent Incisors: a 24-month Randomized Clinical Trial

The current randomized clinical trial will be conducted to evaluate the 24-month clinical and radiographic outcomes after revascularization of asymptomatic necrotic immature permanent maxillary incisors using single- or multiple-visit protocol.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

86

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
      • Minya, Egypt
        • Recruiting
        • Minia University Dental Hospita
        • Contact:
          • Faculty of Dentistry, Minia University
          • Phone Number: 0020159939498

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

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Compliant healthy patients who had at least one immature maxillary permanent incisor requiring nonsurgical root canal treatment.
  • Patients presenting with a diagnosis of pulp necrosis with chronic apical periodontitis confirmed by history, clinical, radiographic and operative examination.
  • Patient without previous endodontic treatment in affected tooth.

Exclusion Criteria:

  • Patients with systemic conditions (medical, developmental or behavioral) that make routine dental treatment difficult.
  • Patients taking medications that can interfere with healing or hemostasis.
  • Patients with allergy to local anesthetics
  • Children who will not comply to recall program.
  • Teeth with extensive loss of coronal tissue that require restoration with a post
  • Teeth with internal or external root resorption

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
Experimental: Single-visit revascularization
Revascularization protocol will be performed in single visit
Procedure: Single-visit revascularization
Revascularization protocol will be performed in single visit
Active Comparator: multiple-visit revascularization
Revascularization protocol will be performed in multiple visits
Procedure: Multiple-visit revascularization
Revascularization protocol will be performed in multiple visit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants experiencing Pain after treatment
Time Frame: From enrollment to the end of treatment at 24 months
Zero is equivalent to no pain and 1 indicates presence of pain that necessitate taking pain killer
From enrollment to the end of treatment at 24 months

Collaborators and Investigators

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

Sponsor

Minia 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)

December 21, 2024

Primary Completion (Estimated)

March 1, 2025

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

December 23, 2024

First Submitted That Met QC Criteria

January 6, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 6, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20241220284

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Ethical Considerations

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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