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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | participants will receive standard root canal treatment with final flush of normal saline at the room temperature after cleaning and shaping and before obturation. |
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| Submucosal cryotherapy infiltration | Experimental | participants will receive Submucosal infiltration injection of 1 mL cryo-treated saline maintained at a temperature of 2 to 5°C before the normal local anaesthetic routine. |
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| Intracanal cryotherapy | Experimental | participants will receive root canal treatment with final flush of cold saline maintained at a temperature of 2 to 5°C |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saline | Drug | Submucosal infiltration injection of 1 mL cryo-treated saline maintained at a temperature of 2 to 5°C before the normal local anaesthetic routine |
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| Measure | Description | Time Frame |
|---|---|---|
| postoperative pain | 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) | After 12 hours |
| postoperative pain | 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) | After 24 hours |
| postoperative pain | 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) | After 48 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Substance P level | Quantification of substance P will be done using an ELISA test from peri-radicular fluid swab. | After 15 minutes from access cavity preparation |
| Substance P level | Quantification of substance P will be done using an ELISA test from peri-radicular fluid swab. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Ain shams University | Cairo | 4543070 | Egypt |
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| ID | Term |
|---|---|
| D003788 | Dental Pulp Diseases |
| D019553 | Tooth, Nonvital |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Saline | Drug | root canal treatment with final flush of cold saline maintained at a temperature of 2 to 5°C |
|
| After 30 minutes from access cavity preparation |
| Substance P level | Quantification of substance P will be done using an ELISA test from peri-radicular fluid swab. | after 24 hour |
| D017670 |
| Sodium Compounds |