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

NCT06804330 | Not Yet Recruiting DMC

• 1 other identifier: FUE.REC(15)/6-2024
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Conditions

Necrotic Pulp with Symptomatic Apical Periodontitis; Postoperative Dental Pain; Antimicrobial Effect

Outcome Measures

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 ''

  6 hours up to 96 hours

Secondary Outcomes (1)

• Bacterial Load

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

Study Arms (3)

Using Plain Selenium paste as intracanal medication .

ACTIVE COMPARATOR

Procedure: root canal treatment and intracanal medicament

Using Selenium mixed with calcium hydroxide as intracanal medication .

ACTIVE COMPARATOR

Procedure: root canal treatment and intracanal medicament

Using Calcium hydroxide as an intracanal medication .

ACTIVE COMPARATOR

Procedure: root canal treatment and intracanal medicament

Interventions

root canal treatment and intracanal medicament PROCEDURE

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

Using Calcium hydroxide as an intracanal medication .; Using Plain Selenium paste as intracanal medication .; Using Selenium mixed with calcium hydroxide as intracanal medication .

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Future University in Egypt: lead

Central Study Contacts

Mohamed Wael Mahmoud, Bachelor

CONTACT

+201156800995; Mohamed.Bakheet@Fue.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching assistant at the department of Endodontics at the faculty of oral and dental medicine

Study Record Dates

• First Submitted: August 5, 2024
• First Posted: February 3, 2025
• Study Start: April 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: October 1, 2025
• Last Updated: March 19, 2025

Record last verified: 2025-03