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Completed

NCT Number: NCT06304259

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

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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Key information

Conditions

Endodontic Disease Dental Pulp Diseases Endodontically Treated Teeth Stomatognathic Diseases Tooth Diseases Tooth, Nonvital

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry, Ain shams University

Cairo, 4543070, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. postoperative pain

    Time frame: After 12 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)

  2. postoperative pain

    Time frame: After 24 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)

  3. postoperative pain

    Time frame: 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 outcomes

  1. Substance P level

    Time frame: After 15 minutes from access cavity preparation

    Quantification of substance P will be done using an ELISA test from peri-radicular fluid swab.

  2. Substance P level

    Time frame: After 30 minutes from access cavity preparation

    Quantification of substance P will be done using an ELISA test from peri-radicular fluid swab.

  3. Substance P level

    Time frame: after 24 hour

    Quantification of substance P will be done using an ELISA test from peri-radicular fluid swab.

Sponsors and collaborators

Lead sponsor

October 6 University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 12, 2024
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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