Effect of Different Modalities of Cryotherapy on Post-Operative Pain in Patients With Symptomatic Irreversible Pulpitis

Not Applicable

Not yet recruiting

• Conditions: Endodontic Disease; Endodontically Treated Teeth
• Interventions: Drug: Saline

• Registration Number: NCT06304259
• Lead Sponsor: October 6 University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-05
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-04
• Study First Posted: 2024-03-12
• Last Update Submitted: 2024-03-24
• Last Update Posted: 2024-03-26
• Study Start: 2024-04
• Primary Completion: 2024-09
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Saline	participants will receive standard root canal treatment with final flush of normal saline at the room temperature after cleaning and shaping and before obturation.
Submucosal cryotherapy infiltration	Saline	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.
Intracanal cryotherapy	Saline	participants will receive root canal treatment with final flush of cold saline maintained at a temperature of 2 to 5°C

Primary Outcome Measures

Name	Time	Method
postoperative pain	After 48 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 Outcome Measures

Name	Time	Method
Substance P level	after 24 hour	Quantification of substance P will be done using an ELISA test from peri-radicular fluid swab.

Trial Locations

Locations (1)

Faculty of Dentistry, Ain shams University; 🇪🇬 Cairo, Egypt