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

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07598188

Enrollment

Registered

2026-05-20

Start date

2026-07-10

Completion date

2027-03-31

Last updated

2026-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periapical Diseases

Keywords

Cold therapy, Saline solution, periapical diseases, sodium hypochlorite

Brief summary

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.

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%.

Interventions

DRUGSaline 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

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
To evaluate the reduction of postoperative pain	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

Countries

Pakistan

Contacts

CONTACTAroosa Bakhtawar, BDS

bakhtawararoosa@gmail.com03379248459

CONTACTSaima Azam, BDS, FCPS

saima.azam@iideas.edu.pk00923005350740

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 21, 2026