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

NCT06304259 | Completed DMC

• 1 other identifier: 24428
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Endodontic Disease; Endodontically Treated Teeth

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Substance P level

  After 15 minutes from access cavity preparation

• Substance P level

  After 30 minutes from access cavity preparation

• Substance P level

  after 24 hour

Study Arms (3)

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.

Drug: Saline

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.

Drug: Saline

Intracanal cryotherapy

EXPERIMENTAL

participants will receive root canal treatment with final flush of cold saline maintained at a temperature of 2 to 5°C

Drug: Saline

Interventions

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

Control; Submucosal cryotherapy infiltration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• October 6 University: lead

Study Sites (1)

Faculty of Dentistry, Ain shams University

Cairo, 4543070, Egypt

Location

MeSH Terms

Conditions

Dental Pulp Diseases; Tooth, Nonvital

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: February 5, 2024
• First Posted: March 12, 2024
• Study Start: April 1, 2024
• Primary Completion: April 1, 2025
• Study Completion: July 1, 2025
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)