Symptomatic Irreversible Pulpitis (SIP)
Conditions
Brief summary
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.
Interventions
final irrigation by NaOcl (2.6%) at room temperature 24°C for 1 min.
PROCEDUREfinal irrigation by Cryotreated NaOcl
final irrigation by Cryotreated NaOcl (2.6%) at 2-4°C for 1 min.
PROCEDUREfinal irrigation by preheated NaOcl
final irrigation by preheated NaOcl (2.6%) at 60°C for 1 min.
PROCEDUREfinal irrigation by NaOCI activated by laser
final irrigation by NaOCI (2.6%) activated by laser for 1 min.
Sponsors
Future University in Egypt
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative pain after each activation method in comparison to control group | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| bacterial load change after final irrigation protocol. | 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. |
Countries
Egypt
Outcome results
None listed