An interventional study of Saline 0.9% (1.5-2.5°C) in Periapical Diseases, sponsored by Islamabad Medical and Dental College. Not yet recruiting at 1 site in Pakistan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-20.
Sponsored by Islamabad Medical and Dental College · Not applicable, Interventional, and Treatment
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.
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%.
46 studies on the registry are indexed under Periapical Diseases; 10 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 37 interventional studies indexed under Periapical Diseases.
Browse Periapical Diseases studies →Islamabad Medical and Dental College is the lead sponsor of 15 studies on the registry; 5 are open to participants now.
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Individual (male/female) with age >18 years with symptomatic apical periodontitis in permanent teeth
Exclusion Criteria:
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 the control group, final irrigation will be performed using 20 mL of 0.9% physiological saline solution at room temperature for 5 min
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
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
Time frame: 24-48 hours
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Jul 2026; primary completion for Jan 2027, 6 months later.
Of 27 non-industry interventional studies with no phase under Periapical Diseases, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 32. This study's planned 6 months is below that.
Counting every sponsor, half of 27 studies reached it within 24 months; a quarter within 12 and three quarters within 32.
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This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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Islamabad Medical and Dental College