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

The Effect of Different Modalities of Cryotherapy on Post-Operative Pain Level in Patients With Symptomatic Irreversible Pulpitis (Randomized Control Trial)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Endodontic Disease; Endodontically Treated Teeth
• Intervention / Treatment: Drug: Saline; Drug: Saline

• Study Type: Interventional
• Enrollment (Estimated): 45
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yara Adel, BDs; Phone Number: 00201000099191; Email: yara.adel170496@gmail.com

Study Locations

• Egypt
  • Cairo, Egypt, 4543070
    • faculty of dentistry, Ain shams university
    • Contact: Yara Adel, BDs; Phone Number: 00201000099191; Email: yara.adel170496@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; participants will receive standard root canal treatment with final flush of normal saline at the room temperature after cleaning and shaping and before obturation.	Drug: Saline; Submucosal infiltration injection of 1 mL cryo-treated saline maintained at a temperature of 2 to 5°C before the normal local anaesthetic routine; Drug: Saline; root canal treatment with final flush of cold saline maintained at a temperature of 2 to 5°C
Experimental: Submucosal cryotherapy infiltration; 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.	Drug: Saline; Submucosal infiltration injection of 1 mL cryo-treated saline maintained at a temperature of 2 to 5°C before the normal local anaesthetic routine; Drug: Saline; root canal treatment with final flush of cold saline maintained at a temperature of 2 to 5°C
Experimental: Intracanal cryotherapy; participants will receive root canal treatment with final flush of cold saline maintained at a temperature of 2 to 5°C	Drug: Saline; Submucosal infiltration injection of 1 mL cryo-treated saline maintained at a temperature of 2 to 5°C before the normal local anaesthetic routine; Drug: Saline; root canal treatment with final flush of cold saline maintained at a temperature of 2 to 5°C

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: October 6 University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): October 1, 2024

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 24, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Stomatognathic Diseases; Tooth Diseases; Pain, Postoperative; Pulpitis; Dental Pulp Diseases; Tooth, Nonvital
• Other Study ID Numbers: 24428

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No