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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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06804330
Enrollment
60
Registered
2025-02-03
Start date
2025-04-01
Completion date
2025-10-01
Last updated
2025-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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

Interventions

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

Sponsors

Future University in Egypt
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
20 Years to 40 Years
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 patients 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.

Design outcomes

Primary

MeasureTime frameDescription
Post-operative pain6 hours up to 96 hoursNumerical 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 ''

Secondary

MeasureTime frameDescription
Bacterial LoadBefore intracanal medication injection and 2 weeks following the procedure and before obturating the root canalsSerial dilution technique For measuring bacterial load preplacement of the medication and 2 weeks postplacement .

Contacts

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026