Evaluation of Postoperative Pain and Antimicrobial Efficacy of Selenium Versus Calcium Hydroxide As Intracanal Medication in Mandibular First Molars with Necrotic Pulp and Symptomatic Apical Periodontitis

March 17, 2025 updated by: Mohamed Wael Mahmoud, Future University in Egypt

The main rational behind intracanal medicament is to kill the bacteria inside the root canal and to avert reinfection. In absence of nutrients, the bacteria remains after obturation in root canal may not survive. Otherwise they may flourish & If the root canal is not dressed properly with antiseptic medicaments between the visits, the residual bacteria may increase . Thus the use of effective intracanal medication for disinfection of root canal is necessitated . Medicament with long effect and least irritated to periradicular tissue has to be introduced to infiltrate the dentinal tubule eliminating bacteria . As the effect of intracanal medicaments is longer than irrigants, it is generally recommended to fill the root canal between appointments with intracanal medicaments. Calcium hydroxide is the most commonly recommended antimicrobial agent for interappointment medications. It serves as an effective intracanal medicament due to its alkaline pH, which inhibits bacterial growth. However, calcium hydroxide has limitations. .Recently selenium(Se) was introduced as intracanal medication .Se is a mineral essential for the formation of the amino acid selenocysteine, which is directly involved in the maintenance of the immune response. Selenium has been widely used in the medical field in the treatment of cancer, as an activator of bone metabolism, and as a stimulator of the immune system. In this study, it will show that the incorporation of Se, whether as intracanal medication alone or in conjunction with other medications, may potentiate periapical tissue repair after RCS cleaning and shaping procedures.

This study consists of 60 patients divided into 3 group each group having 20 patient.

Intervention 1: intracanal medication using selenium alone .

Intervention 2: intracanal medication using selenium with calcium hydroxide

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

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

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Medically free patients with no systemic disease: (American Society of Anesthesiologists / (ASA Class I or II).

    • Age range is between 20 to 40 years.
    • No sex predilection.
    • Patients having necrotic pulp with symptomatic apical periodontitis in mandibular first molars.(type l distal root canal ) .
    • Sensitive to percussion.
    • Periapical radiographic appearance of teeth showed slight widening in lamina dura.
    • restorable teeth.
    • Positive patient"s acceptance for participating in the study.
    • Patients able to sign informed consent.

Exclusion Criteria:

  • Medically compromised patients.

    • Pregnant or lactating females.
    • Psychologically disturbed patients.
    • Patients with a history of allergy to any medication used in the study were excluded.
    • If anti-inflammatory analgesics or antibiotics have been administrated by patient during the past 12 hours preoperatively.
    • Patients with swelling or acute peri-apical abscess or fistulous tract.

Teeth that have:

  • Wide or open apex.
  • Vital pulp tissues.
  • Periodontally affected with grade 2 or 3 mobility.
  • Not restorable teeth.
  • Abnormal anatomy and calcified canals.
  • Previous root canal treatment.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Using Plain Selenium paste as intracanal medication .
Procedure: root canal treatment and intracanal medicament
Root canal biomechanical preparation followed by intracanal placement of intracanal medicament according to the arm
Active Comparator: Using Selenium mixed with calcium hydroxide as intracanal medication .
Procedure: root canal treatment and intracanal medicament
Root canal biomechanical preparation followed by intracanal placement of intracanal medicament according to the arm
Active Comparator: Using Calcium hydroxide as an intracanal medication .
Procedure: root canal treatment and intracanal medicament
Root canal biomechanical preparation followed by intracanal placement of intracanal medicament according to the arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative pain
Time Frame: 6 hours up to 96 hours
Numerical rate scale (NRS) for measuring post-operative pain after 6 hours upto 96 hours 0-10 scale , with zero meaning ''no pain '' and 10 meaning ''the worst pain imaginable ''
6 hours up to 96 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bacterial Load
Time Frame: Before intracanal medication injection and 2 weeks following the procedure and before obturating the root canals
Serial dilution technique For measuring bacterial load preplacement of the medication and 2 weeks postplacement .
Before intracanal medication injection and 2 weeks following the procedure and before obturating the root canals

Collaborators and Investigators

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

Sponsor

Future University in Egypt

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)

June 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

August 5, 2024

First Submitted That Met QC Criteria

January 27, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 17, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUE.REC(15)/6-2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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