- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07852260
Evaluation of Postoperative Pain and the Antimicrobial Effect of Super Oxidized Water (Microcyn) and Chlorhexidine When Compared With Sodium Hypochlorite in Teeth With Asymptomatic Necrotic Pulps. A Randomized Clinical Trial (NRS)
Evaluation of Postoperative Pain and the Antimicrobial Effect of Super Oxidized Water (Microcyn) and Chlorhexidine When Compared With Sodium Hypochlorite in Teeth With Asymptomatic Necrotic Pulps A Randomized Clinical Trial
The objective of this study is to evaluate the postoperative pain and antimicrobial efficacy when using super-oxidized water (Microcyn) and 2% Chlorhexidine as irrigating solutions in comparison to 2.5% Sodium hypochlorite in teeth with asymptomatic necrotic pulps.
Studieöversikt
Status
Detaljerad beskrivning
The objective of this study is to evaluate the postoperative pain and antimicrobial efficacy when using super-oxidized water (Microcyn) and 2% Chlorhexidine as irrigating solutions in comparison to 2.5% Sodium hypochlorite in teeth with asymptomatic necrotic pulps.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Paunceh S Soliman, PHD candidate
- Telefonnummer: 01026999750
- E-post: paunceh.soliman@dentistry.cu.edu.eg
Studieorter
-
-
Cairo Governorate
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Cairo, Cairo Governorate, Egypten, 11553
- faculty of Dentistry Cairo university
-
Kontakt:
- Paunceh S Soliman, PHD candidate
- Telefonnummer: 01026999750
- E-post: paunceh.soliman@dentistry.cu.edu.eg
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- Patients in good physical health; American Society of Anesthesiologists (ASA) class I or II.
- Patients whose age ranges between 18 and 50 years.
- Male and female patients.
- Patients having a single canal-tooth with asymptomatic necrotic pulp.
- Patients who can understand the number rating scale.
- Patients who accept to participate in the trial and can sign the informed consent
Exclusion Criteria:
- Pregnant females.
- Patients with intraoral or extraoral swelling.
- Patients whose tooth is non-restorable.
- Teeth with open apices.
- Teeth with radiographic evidence of root resorption.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Faktoriell uppgift
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Group A
Each canal will receive 2ml of super-oxidized water (Microcyn) irrigating solution between each instrument size and the subsequent one. |
The difference in concentration of chlorine between NaOCl and super oxidized water such that the concentration of chlorine ions in NaOCl is much higher than that in super-oxidized water. However, considering the 90% reduction in biofilm thickness and 98% reduction in colony count of microorganisms by super-oxidized water as demonstrated |
|
Aktiv komparator: Group B
Each canal will receive 2ml of 2% chlorhexidine irrigating solution between each instrument size and the subsequent one. |
Chlorhexidine (CHX) has been indicated as an alternative irrigation agent in the preparation of the root canal system, due to its broad-spectrum antimicrobial capacity, dentin tubule disinfection, dentin adsorption, high substantivity, and low toxicity compared to NaOCl. The inability to dissolve organic tissues of the CHX provides controversial in the use of this irrigant, and due to this limitation, some authors do not indicate it as the main irrigation solution in endodontic treatment despite its utility as a final irrigation solution. |
|
Aktiv komparator: Group C
Each canal will receive 2ml of 2.5 % sodium hypochlorite irrigating solution between each instrument size and the subsequent one. |
Sodium hypochlorite (NaOCl) is the most common and has been widely used in endodontics for more than 70 years because of its ability to act as a solvent for organic matter and its efficient antimicrobial action, however, at high concentrations, it is likely to irritate periradicular tissues. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Postoperative pain intensity at 6 hours post-instrumentation
Tidsram: 6 hours post-instrumentation
|
A pain chart using numerical rating scale (NRS) will then be used to record the patients' pain level. The NRS (0-10 scale) consists of a line anchored by two extremes "No pain" and "the worst pain". Patients will be asked to choose the mark that represented their level of pain from 0 to 10. Pain level will be assigned as follow: 0: no pain, 1-3: mild pain, 4-6: moderate pain, 7-10: severe pain. |
6 hours post-instrumentation
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
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
- Paunceh samy
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
There is no plan to share individual participant data (IPD) with other researchers due to participant confidentiality and privacy considerations.
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