- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Allaa Mohamed Kamel Mohamed, MSC
- Telefonnummer: +201006767773
- E-post: allaa91mk@gmail.com
Studera Kontakt Backup
- Namn: Maged Mohamed Negm, professor
- E-post: drmagednegm@gmail.com
Studieorter
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Minya, Egypten
- Rekrytering
- Minia University, Faculty of Dentistry
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Kontakt:
- Ahmed Ali Yossef, Lecturer
- Telefonnummer: +201007335293
- E-post: ahmed.yousef@mu.edu.eg
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / 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:
Andra namn:
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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:
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Behandling av postoperativ smärta
Tidsram: från 0 timmar till 2 veckor efter proceduren
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Patienter kommer att utvärderas med avseende på postoperativ smärta via (NRS) för att registrera smärtintensiteten.
Följer: 0 Läsning representerar "ingen smärta"; 1- 3 Läsning representerar "mild smärta"; 4- 6 Läsning representerar "måttlig smärta" och 7- 10 läsning representerar "svår smärta".
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från 0 timmar till 2 veckor efter proceduren
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Peripisk läkning
Tidsram: Efter 6 månader till 12 månader
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Peripisk läkning kommer att utvärderas genom att jämföra storleken på den initiala lesionen preoperativt och postoperativt (efter 6 och 12 månader) med användning av periapiska röntgenbilder och CBCT.
Detta kommer att aggregeras i procent (%).
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Efter 6 månader till 12 månader
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Samarbetspartners och utredare
Sponsor
Utredare
- Studiestol: Maged Mohamed Negm, M.D, Professor of Endodontics, Faculty of Dentistry,Cairo University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- NeoSEALER FLO & AH plus sealer
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Studerar en amerikansk FDA-reglerad produktprodukt
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