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Not yet recruiting NCT07598188

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

No phase Interventional Periapical Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Saline 0.9% (1.5-2.5°C).
Who it may be relevant to
Registry conditions: Periapical Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • 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

Primary outcome measures

  • To evaluate the reduction of postoperative pain [Time frame: 24-48 hours]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Sequential
Masking
Single blind
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Islamabad Dental Hospital — Islamabad

Identifiers

NCT: NCT07598188 · IslamabadDentalHospital(IDH)

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗