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Influence of Sealer Composition on Post-Endodontic Pain

Influence of Sealer Composition on Post-Endodontic Pain: A Prospective Comparative Analysis of Three Root Canal Sealers

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07767084
Enrollment
66
Registered
2026-08-17
Start date
2026-04-14
Completion date
2027-04-14
Last updated
2026-08-17

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

Conditions

Post Endodontic Pain

Brief summary

Postoperative pain (PP) is one of the most common and clinically significant complications following endodontic therapy, occurring shortly after treatment and potentially lasting from a few hours to several days, thereby compromising the patient's quality of life. The incidence of PP varies widely in the literature, ranging from 1.7% to 70%, with some studies reporting values up to 80% within the first 24 hours, gradually decreasing over a week.

Detailed description

Postoperative pain (PP) is one of the most common and clinically significant complications following endodontic therapy, occurring shortly after treatment and potentially lasting from a few hours to several days, thereby compromising the patient's quality of life . The incidence of PP varies widely in the literature, ranging from 1.7% to 70%, with some studies reporting values up to 80% within the first 24 hours, gradually decreasing over a week . The pathophysiology of postoperative pain involves mechanical, chemical, or microbial injury to the periapical tissues, which triggers an acute inflammatory response characterized by the release of inflammatory mediators, vasodilation, increased vascular permeability, and leukocyte migration, ultimately activating sensory neurons and generating pain. The etiology of PP is multifactorial, including patient-related factors such as age, gender, tooth type particularly mandibular molars preoperative pain, and periapical radiolucency, as well as treatment-related factors such as instrumentation protocol, irrigation solution, working length determination, occlusal adjustment, number of visits, anesthesia type, and prophylactic analgesics. Understanding these variables allows clinicians to select techniques and materials that minimize postoperative discomfort. Root canal obturation plays a critical role in postoperative pain, as sealers may come into direct contact with periradicular tissues or extrude through the apical foramen, eliciting cytotoxic and inflammatory responses . The chemical composition and biocompatibility of the sealer influence tissue reaction, periapical healing, and subsequent pain perception. Traditionally, epoxy resin-based sealers, such as AH Plus®, have been considered the gold standard due to their excellent sealing properties, radiopacity, dimensional stability, and clinical performance; however, extrusion of these sealers has been associated with cytotoxicity and inflammation. Calcium hydroxide-based sealers have long been used in endodontics, providing antibacterial effects, low cytotoxicity, and osteogenic and cementogenic potential, contributing to periapical repair. More recently, calcium silicate-based bioceramic sealers, including tricalcium silicate formulations like BioRoot and EndoSeal MTA, have gained popularity due to their bioactivity, biocompatibility, ability to set in humid conditions, alkaline pH, calcium ion release, antimicrobial properties, and promotion of tissue regeneration with lower inflammatory mediator production. These properties suggest that bioceramic sealers may reduce postoperative pain compared to traditional sealers, while supporting enhanced periapical healing and osteogenic induction. Despite studies evaluating postoperative pain with different sealers, results remain controversial, and there is limited evidence specifically comparing the effects of epoxy resin-based versus calcium silicate-based sealers on pain outcomes following single-visit endodontic treatment. This highlights a need for further randomized clinical trials to assess the incidence and severity of postoperative pain associated with these materials, particularly in patients with varying pulpal and periapical conditions.

Interventions

PROCEDURECalcium Hydroxide-based Sealer

to evaluate and compare the incidence and intensity of postoperative pain following single-visit root canal treatment using three different root canal sealers-calcium hydroxide-based, calcium silicate-based (bioceramic), and epoxy resin-based sealers-in patients with single-rooted teeth, in order to determine the effect of sealer type on patient comfort and analgesic consumption.

Sponsors

Minia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No

Inclusion criteria

* Patients requiring primary root canal treatment. * Patients with acute irreversible pulpitis. * Patients in good general health

Exclusion criteria

* Patients with systemic diseases affecting pain perception or healing. * Patients who had taken analgesics or antibiotics within 12-24 hours prior to treatment. * Pregnant or lactating women. * Previously treated teeth or teeth with root resorption, fractures, or severe periodontal disease

Design outcomes

Primary

MeasureTime frameDescription
Post Endodontic Pain Intensity7 daysPostoperative pain will be assessed using a 10-cm Visual Analog Scale (VAS), where 0 will indicate "no pain" and 10 will indicate "worst imaginable pain." Participants will be instructed to record their pain intensity at 6, 12, 24, 48, and 72 hours, and on the 7th day after treatment. All recorded pain scores will be collected for statistical analysis and comparison among the study groups

Countries

Egypt

Contacts

CONTACTNourhan Rabie Ahmed Ahmed, B.D.S
nourhan.rabie93@gmail.com+201148809567
CONTACTDalia Ali Ahmed Moukarab, Professor
dalia.mokarab@mu.edu.eg+201068121523
STUDY_CHAIRDalia Ali Ahmed Moukarab, Professor

Professor and Head of the Endodontics Department, Faculty of Dentistry

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 18, 2026