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

Endodontically Treated Teeth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06304259
• Other study ID #: 24428
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: October 1, 2024

Study information

• Verified date: March 2024
• Source: October 6 University
• Contact: Yara Adel, Bds
• Phone: 00201000099191
• Email: yara.adel170496[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 45
• Est. completion date: October 1, 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dental Pulp Diseases
• Endodontic Disease
• Endodontically Treated Teeth
• Pain, Postoperative
• Pulpitis
• Tooth, Nonvital

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Dentistry, Ain shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
October 6 University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Substance P level	Quantification of substance P will be done using an ELISA test from peri-radicular fluid swab.	after 24 hour