CClinicalTrials.gg
Not yet recruitingNCT06804330Updated Mar 19, 2025

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

An interventional study of root canal treatment and intracanal medicament in Necrotic Pulp with Symptomatic Apical Periodontitis, Postoperative Dental Pain and Antimicrobial Effect, sponsored by Future University in Egypt. Not yet recruiting. Open to participants aged 20 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-19.

Sponsored by Future University in Egypt · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
20 Years to 40 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Necrotic Pulp with Symptomatic Apical Periodontitis
  • Postoperative Dental Pain
  • Antimicrobial Effect
03

Who can participate

Ages eligible
20 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Using Plain Selenium paste as intracanal medication .

    Procedure: root canal treatment and intracanal medicament

  • Active comparator
    Using Selenium mixed with calcium hydroxide as intracanal medication .

    Procedure: root canal treatment and intracanal medicament

  • Active comparator
    Using Calcium hydroxide as an intracanal medication .

    Procedure: root canal treatment and intracanal medicament

Interventions

  • Procedureroot canal treatment and intracanal medicament

    Root canal biomechanical preparation followed by intracanal placement of intracanal medicament according to the arm

05

What researchers measure

Primary outcomes

  1. Post-operative pain

    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 ''

    Time frame: 6 hours up to 96 hours

Secondary outcomes

  1. Bacterial Load

    Serial dilution technique For measuring bacterial load preplacement of the medication and 2 weeks postplacement .

    Time frame: Before intracanal medication injection and 2 weeks following the procedure and before obturating the root canals

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06804330
Lead sponsor
Future University in Egypt
Responsible party
Mohamed Wael Mahmoud (Teaching assistant at the department of Endodontics at the faculty of oral and dental medicine, Future University in Egypt) — Principal investigator
First posted
Feb 3, 2025
Start date
Apr 1, 2025 (estimated)
Primary completion
Jun 1, 2025 (estimated)
Completion
Oct 1, 2025 (estimated)
Last update
Mar 19, 2025

Study contacts

Mohamed Wael Mahmoud, Bachelor
Contact
Mohamed.Bakheet@Fue.edu.eg
+201156800995

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion