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

October 6 University

Status

Completed

Conditions

Endodontic Disease

Endodontically Treated Teeth

Treatments

Drug: Saline

Study type

Interventional

Funder types

Other

Identifiers

NCT06304259

24428

Details and patient eligibility

About

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.

Enrollment

45 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

45 participants in 3 patient groups

Control

Active Comparator group

Description:

participants will receive standard root canal treatment with final flush of normal saline at the room temperature after cleaning and shaping and before obturation.

Treatment:

Drug: Saline

Submucosal cryotherapy infiltration

Experimental group

Description:

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.

Treatment:

Drug: Saline

Intracanal cryotherapy

Experimental group

Description:

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

Treatment:

Drug: Saline