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NCT Number: NCT07598188

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Islamabad Dental Hospital

Islamabad, Federal, 44000, Pakistan

Location contact

Aroosa Bakhtawar, BDS

CONTACT

[email protected]

03379248459

Saima Azam, BDS, FCPS

CONTACT

About this study

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%.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Saline 0.9% (1.5-2.5°C)

Drug

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

Primary outcomes

  1. To evaluate the reduction of postoperative pain

    Time frame: 24-48 hours

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Aroosa Bakhtawar, BDS

CONTACT

[email protected]

03379248459

Saima Azam, BDS, FCPS

CONTACT

[email protected]

00923005350740

Sponsors and collaborators

Lead sponsor

Islamabad Medical and Dental College

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 20, 2026
Registry last updated
May 20, 2026

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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