- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Allaa Mohamed Kamel Mohamed, MSC
- Telefonnummer: +201006767773
- E-mail: allaa91mk@gmail.com
Undersøgelse Kontakt Backup
- Navn: Maged Mohamed Negm, professor
- E-mail: drmagednegm@gmail.com
Studiesteder
-
-
-
Minya, Egypten
- Rekruttering
- Minia University, Faculty of Dentistry
-
Kontakt:
- Ahmed Ali Yossef, Lecturer
- Telefonnummer: +201007335293
- E-mail: ahmed.yousef@mu.edu.eg
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde 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 undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: AH plus sealer
About 15 cases will undergo the AH plus sealer during obturation After complete preparation of the root canal system
|
to evaluate and compare postoperative pain and periapical healing after root canal treatment using two different base endodontic sealers:
Andre navne:
|
|
Aktiv komparator: NeoSEALER FLO
About 15 cases will undergo the Neo Sealer FLO during obturation After complete preparation of the root canal system
|
to evaluate and compare postoperative pain and periapical healing after root canal treatment using two different base endodontic sealers:
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Behandling af postoperativ smerte
Tidsramme: fra 0 timer til 2 uger efter proceduren
|
Patienterne evalueres for postoperativ smerte via (NRS) for at registrere intensiteten af smerter. Som
følger: 0 læsning repræsenterer "ingen smerte"; 1- 3 læsning repræsenterer "mild smerte"; 4- 6 læsning repræsenterer "moderat smerte", og 7- 10 læsning repræsenterer "alvorlig smerte".
|
fra 0 timer til 2 uger efter proceduren
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Periapisk helbredelse
Tidsramme: Efter 6 måneder til 12 måneder
|
Periapisk heling vil blive evalueret ved at sammenligne størrelsen på den indledende læsion før operativt og postoperativt (efter 6 og 12 måneder) ved anvendelse af periapiske røntgenbilleder og CBCT.
Dette vil blive samlet i procent (%).
|
Efter 6 måneder til 12 måneder
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Maged Mohamed Negm, M.D, Professor of Endodontics, Faculty of Dentistry,Cairo University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- NeoSEALER FLO & AH plus sealer
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .