Endodontically Treated Teeth, Endodontic Disease
Conditions
Brief summary
Problem statement: The post-operative pain after endodontic treatment. aim of study: The study is aiming to compare postoperative pain after submucosal cold saline injection (submucosal cryotherapy) (SMC) versus intra-canal cryotherapy (ICC) in mandibular single rooted premolars with symptomatic irreversible pulpitis with symptomatic apical periodontitis (SAP). The material and methods: Subjects and methods: sixty patients will be randomly divided into three groups: the SMC group, the ICC group, and the control group. The patients' postoperative pain will be recorded at 12, 24, and 48 hours postoperatively by questioning them. Quantification of substance P will be done using an ELISA test from peri-radicular fluid swab.
Interventions
DRUGSaline
Submucosal infiltration injection of 1 mL cryo-treated saline maintained at a temperature of 2 to 5°C before the normal local anaesthetic routine
Sponsors
October 6 University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Older than age of 18 years * Participants willing to commit for the entire period of the trial and Both genders * agreed to sign the written consent after full explanation of the study * Having a mandibular single rooted premolar tooth with vital pulp * These patients were also suffering from symptoms of symptomatic irreversible pulpitis and apical periodontitis, intermittent or continuous sharp pain that lasts longer after removal of the stimulus. on the basis of the clinical symptoms of severe preoperative pain (visual analogue scale)
Exclusion criteria
* Vulnerable group; prisoners, pregnant females, mentally ill, etc… * Teeth with open apices * A previous root canal treatment * Sinus tracts * Presence of periodontal pockets \>3 mm in the affected tooth
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| postoperative pain | After 12 hours | measure intensity of post operative pain using visual analogue scale that was represented by a 100 mm horizontal ruler with no number markings other than a 0 at one end and a 10 at the other end. The following categories of postoperative pain levels were used to assess pain: 0 indicating no pain, mild pain (1-3), moderate pain (4-7) and severe pain (8-10) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Substance P level | After 15 minutes from access cavity preparation | Quantification of substance P will be done using an ELISA test from peri-radicular fluid swab. |
Countries
Egypt
Outcome results
None listed