Effect of Intracanal Cryotherapy Versus Laser Application on Postoperative-pain and Bacterial Load Reduction in Single Visit Root Canal Treatment in Patients With Symptomatic Irreversible Pulpitis in Mandibular First Molar Teeth (Randomized Control Trial)
31. maj 2026 opdateret af: Albatool Rummani, Future University in Egypt
This randomized controlled clinical trial investigates the Effect of Intracanal Cryotherapy Versus Laser Application on Post-Operative Pain and Bacterial Load Reduction in Single-Visit Root Canal Treatment in Patients with Symptomatic Irreversible Pulpitis in Mandibular First Molars.
Sixty patients aged 18-40 years with restorable mandibular first molars diagnosed with symptomatic irreversible pulpitis will be enrolled at the Endodontic Department, Faculty of Oral and Dental Medicine, Future University in Egypt.
Participants will be randomly allocated into four groups: Group 1 (control) will receive final irrigation with 2.6% sodium hypochlorite (NaOCl) at room temperature (24°C), Group 2 will receive cryotreated NaOCl (2-4°C), Group 3 will receive preheated NaOCl (60°C), and Group 4 will receive laser-activated NaOCl, each applied for one minute.
The study will be double-blind for both the operator and the patient.
Post-operative pain will be assessed using a Numerical Rating Scale (0-10) at 6, 12, 24, 48, and 72 hours post-treatment.
Bacterial load reduction will be measured microbiologically at three stages: after access cavity preparation, after instrumentation, and after final irrigation.
Statistical analysis will be performed using SPSS version 24 and Minitab version 16, with a significance level of p < 0.05.
The study has received ethical approval from the Future University Ethics Committee and is conducted without external funding.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
60
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
New Cairo
-
Cairo, New Cairo, Egypten, 11835
- Future University in Egypt
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Patients aged 18 to 40 years.
- Patients able to understand and sign the informed consent form.
- Patients who positively accept to participate in the study.
- Patients diagnosed with symptomatic irreversible pulpitis in a restorable mandibular first molar.
- The affected tooth must have a mesial and distal root canal configuration classified as Type III according to Vertucci's classification.
- The root curvature of the involved canals must be mild to moderate (5-20°), as measured by Schneider's method.
- No sex predilection.
Exclusion Criteria:
- Patients who are pregnant or lactating.
- Medically compromised patients (e.g., with systemic conditions that contraindicate dental treatment or affect pain perception).
- Patients who have taken any analgesic medication within 8 hours prior to the appointed treatment.
- Patients who have taken antibiotics within the two weeks prior to the preoperative assessment.
- Patients with parafunctional habits such as bruxism or clenching.
- Patients with severe malocclusion associated with traumatic occlusion.
Teeth exhibiting any of the following:
- Pain on percussion.
- A diagnosis of peri-apical periodontitis or a peri-radicular lesion.
- Internal or external root resorption.
- Pulp stones or significant canal calcifications.
- Evidence of previous endodontic treatment.
- Teeth with non-patent canals or canals that cannot be negotiated.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: Final irrigation by NaOCI at room temperature
final irrigated using NaOCI (2.6%) at room temperature 24°C for 1 min.
|
final irrigation by preheated NaOcl (2.6%) at 60°C for 1 min.
|
|
Aktiv komparator: Final Irrigation by Cryotreated NaOCI
final irrigated using NaOCI (2.6%) that Cryotreated at 2-4°C for 1 min.
|
final irrigation by NaOCI (2.6%) activated by laser for 1 min.
|
|
Aktiv komparator: Final Irrigation by Preheated NaOCI
final irrigated using NaOCI (2.6%) Preheated at 60°C for 1 min.
|
final irrigation by Cryotreated NaOcl (2.6%) at 2-4°C for 1 min.
|
|
Aktiv komparator: Final Irrigation by Laser Activated NaOCI
finally irrigated using NaOCI (2.6%) activated by laser for 1 min.
|
final irrigation by NaOcl (2.6%) at room temperature 24°C for 1 min.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Post-operative pain after each activation method in comparison to control group
Tidsramme: from 6 to 72 hours from the treatment
|
measuring Post-operative pain by Numerical rate scale and pain level will be assigned to one of 4 categorical score: none (0): mild (1-3), severe (7-10).
|
from 6 to 72 hours from the treatment
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
bacterial load change after final irrigation protocol.
Tidsramme: immediately after the intervention
|
Recording the percentage of bacterial load reduction by collecting samples by paper points, first sample after access cavity and before Root canal treatment.
second sample after mechanical instrumentation third sample after final irrigation.
|
immediately after the intervention
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. juli 2025
Primær færdiggørelse (Anslået)
1. november 2026
Studieafslutning (Anslået)
1. december 2026
Datoer for studieregistrering
Først indsendt
31. maj 2026
Først indsendt, der opfyldte QC-kriterier
31. maj 2026
Først opslået (Faktiske)
4. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
4. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
31. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- ARummani
Plan for individuelle deltagerdata (IPD)
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