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

NCT ID: NCT06304259

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-07-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Saline

Intervention Type: 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

Saline

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Saline

Intervention Type: 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

Intracanal cryotherapy

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

Group Type: EXPERIMENTAL

Saline

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

Saline

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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

October 6 University

OTHER

Sponsor Role: lead

Responsible Party

Yara Adel Mohamed Taha

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Dentistry, Ain shams University

Cairo, , Egypt

Countries

Egypt

Other Identifiers

24428

Identifier Type: -

Identifier Source: org_study_id