- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07785973
Effect of NeoSEALER FLO and AH Plus Resin Sealer on Postoperative Pain and Healing of Periapical Lesions
Effect of NeoSEALER FLO and AH Plus Resin Sealer on Postoperative Pain and Healing of Periapical Lesions: A Randomized Clinical Study
Tissue repair is an essential process that reestablishes tissue integrity and regular function. Nevertheless, different therapeutic factors and clinical conditions may interfere in this process of periapical healing.The success of root canal treatment is affected by the correct choice of clinical protocol.
These factors are dependent on the sanitization process (instrumentation, irrigating solution, irrigating strategies, and intracanal dressing) the apical limit of the root canal preparation and obturation, and the quality of the sealer. The challenges affecting the healing process of endodontically treated teeth include control of the inflammation of pulp or infectious processes and simultaneous neutralization of unpredictable provocations to the periapical tissue.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
The goal of root canal obturation is to obtain complete sealing to hinder the communication between the root canal and the periapical tissue. This favors the process of apical and periapical repair after endodontic therapy.An ideal root canal sealer must have adequate physical, chemical, and biological properties.
Several factors can affect the success of RCT, including the type and composition of sealer utilized. The presence and release of substances from the sealers can cause different reactions when in contact with tissue.
AH Plus, an epoxy resin-based sealer, is considered the gold standard among root canal sealers due to its excellent physical, chemical, and biological properties. However, the biocompatibility of this sealer remains a subject of debate, as some studies raise concerns about potential inflammatory responses or cytotoxic effects associated with resin-based sealers.
Recent advancements have introduced bioceramic-based sealer composed of zirconium oxide, calcium silicates, calcium phosphates, and calcium hydroxide. This sealer is available in pre-mixed syringes for easy application and exhibit hydrophilic properties, allowing for setting reactions in a moist environment within the root canal, thus preventing shrinkage. Moreover, bioceramic-based sealers exhibit favorable biocompatibility due to their similarity to dentin and ability to stimulate mineralization.
NeoSealer Flo (NeoFlo, NuSmile, Houston, TX, USA) is a ready-to-use bioceramic root canal sealer. According to the manufacturer, it has hydroxyapatite formation ability, biocompatibility, dimensional stability, and antimicrobial activity. NeoFlo has adequate physicochemical properties and releases biologically active ions, such as calcium and phosphate. The addition of cetrimide to NeoSealer Flo promoted a greater inflammatory reaction, but the reduction of inflammatory cells and rearrangement of connective tissue suggests that NeoSealer Flo and the associations with cetrimide are biocompatible and have bioactive potential.
Endodontic treatment comprises the overall management of pre-, intra- and post-operative symptoms, including post-operative endodontic pain, considered as a complication susceptible to chronicization. Post-operative pain is very common and highly unpreventable and has a multifactorial etiology and a potential pathogenic link to the acute inflammation of the periapical area, secondary to localized chemical, mechanical, host and/or microbial damage occurring during endodontic treatment.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Allaa Mohamed Kamel Mohamed, MSC
- Telefonnummer: +201006767773
- E-post: allaa91mk@gmail.com
Studer Kontakt Backup
- Navn: Maged Mohamed Negm, professor
- E-post: drmagednegm@gmail.com
Studiesteder
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Minya, Egypt
- Rekruttering
- Minia University, Faculty of Dentistry
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Ta kontakt med:
- Ahmed Ali Yossef, Lecturer
- Telefonnummer: +201007335293
- E-post: ahmed.yousef@mu.edu.eg
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Patients with mature permanent teeth.
- Patients with apical periodontitis.
- Maxillary anterior teeth only will be involved.
- Patients should be free from any systemic disease that may affect normal healing and predictable outcome.
- Patients who will agree to the consent and will commit to follow-up period.
- The selected teeth should have periapical lesion score ≤3
Exclusion Criteria:
- Patients with immature canals.
- Patients with swelling.
- Pregnant females.
- Patients who could/would not participate in a 1-year follow-up.
- Geriatric patients.
- Patients with old age.
- Teeth with periodontal involvement.
- Teeth with vertical root fractures.
- Non-restorable teeth.
- cases with previously initiated endodontic treatment.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: AH plus sealer
About 15 cases will undergo the AH plus sealer during obturation After complete preparation of the root canal system
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to evaluate and compare postoperative pain and periapical healing after root canal treatment using two different base endodontic sealers:
Andre navn:
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Aktiv komparator: NeoSEALER FLO
About 15 cases will undergo the Neo Sealer FLO during obturation After complete preparation of the root canal system
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to evaluate and compare postoperative pain and periapical healing after root canal treatment using two different base endodontic sealers:
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Behandling av postoperativ smerte
Tidsramme: fra 0 timer til 2 uker etter inngrepet
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Pasienter vil bli evaluert for postoperativ smerter via (NRS) for å registrere smertenes intensitet.
Følger: 0 lesing representerer "ingen smerter"; 1- 3 lesing representerer "mild smerte"; 4- 6-lesing representerer "Moderat smerte" og 7- 10 lesing representerer "alvorlig smerte".
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fra 0 timer til 2 uker etter inngrepet
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Periapisk helbredelse
Tidsramme: Etter 6 måneder til 12 måneder
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Periapisk helbredelse vil bli evaluert ved å sammenligne størrelsen på den innledende lesjonen pre-operativt og postoperativt (etter 6 og 12 måneder), ved bruk av periapiske røntgenbilder og CBCT.
Dette vil bli samlet i prosent (%).
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Etter 6 måneder til 12 måneder
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studiestol: Maged Mohamed Negm, M.D, Professor of Endodontics, Faculty of Dentistry,Cairo University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NeoSEALER FLO & AH plus sealer
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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