- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT05074628
Effect of Nitrofurantion Used as an Intracanal Medicament
Effect of Nitrofurantion Used as an Intracanal Medicament on the Intensity of Postoperative Pain and Bacterial Load Reduction Versus Calcium Hydroxide in Teeth With Necrotic Pulp: A Randomized Clinical Trial
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Tidlig fase 1
Kontakter og lokationer
Studiekontakt
- Navn: Noha M Elsaber, Master
- Telefonnummer: 00201157157197
- E-mail: nohaalsaber@dentistry.cu.edu.eg
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
1- Age between 18-50 years old. 2-Males or females. 3-Healthy patients whom are categorized as I or II according to The American Society of Anesthesiologists. (ASA I or II) 4-Patients' accepting to participate in the trial. 5-Patients who can understand pain scale and can sign the informed consent. 6- Mandibular Single rooted premolars, having single root canal:
- Diagnosed clinically with pulp necrosis.
- Absence of spontaneous pain
- Slight widening in the periodontal membrane space or with periapical radiolucency not exceeding 2*2 mm radiographically.
- Normal occlusal contact with opposing teeth.
Exclusion Criteria:
1- Medically compromised patients having significant systemic disorders (ASA III or IV).
2-If analgesics or antibiotics have been administrated by the patient during the past 24 hours preoperatively as it might alter their pain perception.
3-Pregnant women: to avoid radiation exposure, anaesthesia, medication and hormonal Fluctuation that might increase pain prevalence.
4-Patients reporting bruxism, clenching, TMJ problems or traumatic occlusion: to avoid further pressure on inflamed tooth which induce subsequent irritation and inflammation.
5-Patients with two or more adjacent teeth requiring endodontic treatment. 6- Teeth that requires further procedural steps or multidisciplinary approach, which is out of this experiment's scope: i.Association with swelling or fistulous tract. ii. Acute periapical abscess. iii. Mobility Grade II or III. iv. Pocket depth more than 5mm. v. Previous root canal treatment. vi. Non-restorable. vii. Immature root. Vii. Radiographic evidence of external or internal root resorption, vertical root fracture, perforation, calcification.
7-Inability to perceive the given instructions.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Nitrofurantion
is the drug of choice for the treatment of infections caused by multidrug resistant pathogens.
|
methyl cellulose powder (MC) will be added to Nit solution to get a thick paste like consistency mixture.
|
|
Aktiv komparator: Calcium Hydroxide
Most commonly used intracanal medicaments .
Antimicrobial activity of calcium hydroxide is related to the release of hydroxyl ions in an aqueous environment.
|
methyl cellulose powder (MC) will be added to Nit solution to get a thick paste like consistency mixture.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Postoperative pain
Tidsramme: 2 Weeks
|
measured using numerical rating scale (NRS), 6, 12, 24, 48 hours:
|
2 Weeks
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Bacterial load reduction
Tidsramme: 2 Weeks
|
determined by bacterial counting using agar culture technique after root canal preparation (CFU/ml).
|
2 Weeks
|
|
Incidence of inter-appointment flare up
Tidsramme: 2 Weeks
|
measured using visual analog scale of postoperative swelling (VAS).
|
2 Weeks
|
|
Incidence of analgesic intake
Tidsramme: 2 Weeks
|
numerical counting.
|
2 Weeks
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Forventet)
Primær færdiggørelse (Forventet)
Studieafslutning (Forventet)
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
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ICM (Anden identifikator: BIOTRONIK)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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-
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