The Effect of Anti-inflammatory Cryoagent on the Level of Postoperative Pain in Patients With Symptomatic Irreversible Pulpitis and Apical Periodontitis.
Trial Snapshot
- Phase
- Phase 2
- Status
- Not yet recruiting
- Sponsor
- Ain Shams University
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Level of Post-operative pain.
Study Overview
Brief Summary
- The aim of this study is comparative between:
- Intra-radicular cryotherapy using cold anti-inflammatory {ketorolac tromethamine at 2-5C}.
- Intra-radicular final flush anti-inflammatory {ketorolac tromethamine at room temperature}.
- In terms of:
C. Level of post-operative pain {POP} using a visual analog scale {VAS}. D. Level of substance P in periapical fluid will be analyzed by enzyme-linked immunosorbent assay (ELISA) kit.
Outcomes :
- Primary outcomes: Level of Post-operative pain.
- Secondary outcomes: Level of substance P expression
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Sequential
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Patients that will be diagnosed with symptomatic irreversible pulpitis and apical periodontitis.
- •Patient age ranging from 18-40 years.
- •Males or females.
- •Lower premolars.
- •Medically free patients.
- •Teeth with mature apex.
- •Teeth without any type of root resorption.
Exclusion Criteria
- •Patients with other pulpal diagnosis.
- •Medically compromised patients.
- •Vulnerable group; pregnant females, mentally ill, etc...
- •Patients taking analgesics or anti-inflammatory drugs.
- •Teeth with open apex.
Arms & Interventions
Intra-radicular saline at room temperature
- Final flush with 20 mL of saline solution
- At room temperature for 5 minutes.
- Three samples will be collected from periapical fluid .
Intervention: anti-inflammatory ketorolac tromethamine (Drug)
Outcomes
Primary Outcomes
Level of Post-operative pain.
Time Frame: 48 hours post operative
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)
Level of pre-operative pain.
Time Frame: before start the operative
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)
Level of Post-operative pain.
Time Frame: 6 hours post operative
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)
Level of Post-operative pain.
Time Frame: 24 hours post operative
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)
Level of Post-operative pain.
Time Frame: 72 hours post operative
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 Outcomes
- Level of substance P expression.(Immediately prior to obturation)
- Level of substance P expression.(15 minutes following access cavity preparation.)
- Level of substance P expression.(30 minutes following access cavity preparation.)
Investigators
abdulrahman ziad elwadiah
abdelrahman_ziad_kasem@dent.asu.edu.eg
Ain Shams University