Evaluation of Post Operative Pain After Using Intracranial Cryotherapy During Single Visit RCT

Evaluation of Post Operative Pain After Using Intracranial Cryotherapy During Single Visit Root Canal Treatment in Teeth With Symptomatic Apical Periodontitis

A total of 60 patients presenting with single-rooted teeth exhibiting symptomatic apical periodontitis were subjected to a randomized allocation into two groups of 30 each. Irrigation was done using 3% sodium hypochlorite for 5 seconds in all 60 teeth. Group 1 underwent final irrigation utilizing normal saline at room temperature. Group 2 received final irrigation using normal saline refrigerated between 2-5°C. Pain levels were assessed and recorded before the procedure and at 24 and 48-hour time intervals.

Study Overview

• Status: Not yet recruiting
• Conditions: Periapical Diseases
• Intervention / Treatment: Drug: Saline 0.9% (1.5-2.5°C)

Detailed Description

Objective:

To compare the reduction in post operative pain of treatment group with control group using normal; saline at room temperature at 24 and 48 hours

Methodology:

A total of 60 patients presenting with single-rooted teeth exhibiting symptomatic apical periodontitis were subjected to a randomized allocation into two groups of 30 each. Irrigation was done using 3% sodium hypochlorite for 5 seconds in all 60 teeth. Group 1 underwent final irrigation utilizing normal saline at room temperature. Group 2 received final irrigation using normal saline refrigerated between 2-5°C. Pain levels were assessed and recorded before the procedure and at 24 and 48-hour time intervals.

Statistical analysis:

Statistical packages for the Social Sciences (SPSS) Version 22 will be used for data analysis. Mean and SD and Frequencies will be used for quantitative variables (Age and pain), and frequency and percentage for qualitative variable (gender). The continuous variable pain score will be compared among control and cryotherapy group by using independent sample t test. Effect modifiers ( age and gender) will be stratified by using post stratified independent sample t test .The P value < 0.05 will be considered as the threshold for statistical significance, at a confidence interval of 95%.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aroosa Bakhtawar, BDS; Phone Number: 03379248459; Email: bakhtawararoosa@gmail.com
• Study Contact Backup: Name: Saima Azam, BDS, FCPS; Phone Number: 00923005350740; Email: saima.azam@iideas.edu.pk

Study Locations

• Pakistan
  • Federal
    • Islamabad, Federal, Pakistan, 44000
      • Islamabad Dental Hospital
      • Contact: Aroosa Bakhtawar, BDS; Phone Number: 03379248459; Email: bakhtawararoosa@gmail.com
      • Contact: Saima Azam, BDS, FCPS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Individual (male/female) with age >18 years with symptomatic apical periodontitis in permanent teeth

Exclusion Criteria:

1. Teeth with calcified canals or aberrant root anatomy,
2. Female Pregnant patients
3. Patients using medications such as analgesics or anti-biotics drugs and
4. Those who refuse to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; In the cryotherapy group, following completion of biomechanical preparation, the root canals will be irrigated with 20ml of 0.9% physiological saline solution at a temperature of 1.5-2.5°C for 5 min	Drug: Saline 0.9% (1.5-2.5°C); In this study participant are suing 0.9% normal saline but the temperature will be different for both groups .In cryotherapy group participant are using saline at cold temperature1.5-2.5°C
No Intervention: Control Group; In the control group, final irrigation will be performed using 20 mL of 0.9% physiological saline solution at room temperature for 5 min

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the reduction of postoperative pain	Patients will be instructed to record their pain score on VAS at 24 and 48 h. and will be asked to contact and visit in case they experience severe pain. If visit is not possible,a telephonic feedback will be recorded and assistance will be guided	24-48 hours

Collaborators and Investigators

• Sponsor: Islamabad Medical and Dental College

Study record dates

Study Major Dates

• Study Start (Estimated): July 10, 2026
• Primary Completion (Estimated): January 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: May 12, 2026
• First Submitted That Met QC Criteria: May 19, 2026
• First Posted (Actual): May 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Cold therapy, Saline solution, periapical diseases, sodium hypochlorite
• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Jaw Diseases; Periapical Diseases; Inorganic Chemicals; Chlorine Compounds; Sodium Compounds; Chlorides; Hydrochloric Acid; Sodium Chloride
• Other Study ID Numbers: IslamabadDentalHospital(IDH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No