Postoperative Pain and Incidence of Extrusion Following the Use of Two Intra-canal Medications in Retreatment of Single Rooted Teeth

April 3, 2025 updated by: Ahmed Ali, Minia University

This study aims to compare the postoperative pain and incidence of extrusion of two intracanal medications in the retreatment of single-rooted teeth.

The main question it aims to answer is:

Does the injection of intra-canal medication into the shaped root canal after complete removal of the old obturating material lead to post-operative pain and paste extrusion to periapical tissues or not?

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Phase 2

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
  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with failed endodontic treatment in single root teeth
  • Systemic free

Exclusion Criteria:

  • Muktirooted teeth

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: Group A: Metapex
Non- surgical root canal retreatment with application of Metapex in to root canal after complete removal of the old obturation material.
Other: Metapex
Intra-canal medication
Experimental: Group A:Bio-c Temp
Non- surgical root canal retreatment with application of Bio-c Temp paste in to root canal after complete removal of the old obturation material.
Other: Bio-c Temp
Intra-canal medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical assessment of the post retreatment pain.
Time Frame: One week after re-treatment procdure
Pain scores will be recorded on visual analog scale (VAS) using a 0 to 10 pain score basis with 0 being no pain and 10 being the worst pain the patient had ever experienced. (Record will be every 24h for 7 days)
One week after re-treatment procdure
Radiographic assessment of the extrusion of the paste into periapical tissues using Digital radiograph
Time Frame: Immediate after retreatment
Extrusion of the paste into periapical incidence of extrusion: Conventional digital radiograph will be taken after using intracanal medication pastes.
Immediate after retreatment

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 (Estimated)

April 1, 2025

Primary Completion (Estimated)

May 1, 2025

Study Completion (Estimated)

May 1, 2025

Study Registration Dates

First Submitted

March 20, 2025

First Submitted That Met QC Criteria

April 3, 2025

First Posted (Actual)

April 6, 2025

Study Record Updates

Last Update Posted (Actual)

April 6, 2025

Last Update Submitted That Met QC Criteria

April 3, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1026/114

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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