- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07767084
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
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Nourhan Rabie Ahmed Ahmed, B.D.S
- Telefonní číslo: +201148809567
- E-mail: nourhan.rabie93@gmail.com
Studijní záloha kontaktů
- Jméno: Dalia Ali Ahmed Moukarab, Professor
- Telefonní číslo: +201068121523
- E-mail: dalia.mokarab@mu.edu.eg
Studijní místa
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Minya, Egypt
- Nábor
- Endodontics Department Faculty of Dentistry
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Kontakt:
- Mohamed Abdel Mawla Mohamed Morsi, Lecturer
- Telefonní číslo: +201005757045
- E-mail: Dr.mohammed.abdelmawla@gmail.com
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: Group A (Calcium Hydroxide-based Sealer: Sealapex):
About 22 cases will be subjected to:
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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.
Ostatní jména:
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Aktivní komparátor: Group B (Bioceramic Sealer: Well-Root):
About 22 cases will be subjected to:
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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.
Ostatní jména:
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Aktivní komparátor: Group C (Resin-based Sealer: ADSEAL):
About 22 cases will be subjected to:
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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.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Post Endodontic Pain Intensity
Časové okno: 7 days
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Postoperative 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
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7 days
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Studijní židle: Dalia Ali Ahmed Moukarab, Professor, Professor and Head of the Endodontics Department, Faculty of Dentistry
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- Post-Endodontic Pain
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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