Periapical DiseasesNCT07598188
Evaluation of Post Operative Pain After Using Intracranial Cryotherapy During Single Visit RCT
A study testing Saline 0.9% (1.5-2.5°C) in people with Periapical Diseases, run by Islamabad Medical and Dental College at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periapical Diseases
- What is being tested?
- Saline 0.9% (1.5-2.5°C)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Jul 2026to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individual (male/female) with age >18 years with symptomatic apical periodontitis in permanent teeth
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Islamabad Dental Hospital
Islamabad, Federal, 44000
Aroosa Bakhtawar, BDS, 03379248459, bakhtawararoosa@gmail.com
Saima Azam, BDS, FCPS
About this study
Official title: 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.
Read the 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%.
- Conditions
- Periapical Diseases
- Being tested
- Saline 0.9% (1.5-2.5°C)
- Keywords
- Cold therapy, Saline solution, periapical diseases, sodium hypochlorite
- Medical subject headings
- Periapical Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | 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 Receives: Drug: Saline 0.9% (1.5-2.5°C) |
| Control Group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 24-48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start10 Jul 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periapical DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Islamabad Medical and Dental College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07598188
- Sponsor's protocol ID
- IslamabadDentalHospital(IDH)
- Status last verified
- May 2026
- First submitted
- 12 May 2026
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Post Operative Pain After Using Intracranial Cryotherapy During Single Visit Root Canal Treatment in Teeth With Symptomatic Apical Periodontitis
- ClinicalTrials.gov ID
- NCT07598188
- Acronym / sponsor ID
- IslamabadDentalHospital(IDH)
- Conditions
- Periapical Diseases
- Keywords
- Cold therapy, Saline solution, periapical diseases, sodium hypochlorite
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Islamabad Medical and Dental CollegeUniversity, hospital or other
- Study start
- 10 Jul 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 20 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Drug: Saline 0.9% (1.5-2.5°C)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 |
| Control Group | No intervention | –In the control group, final irrigation will be performed using 20 mL of 0.9% physiological saline solution at room temperature for 5 min |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individual (male/female) with age >18 years with symptomatic apical periodontitis in permanent teeth
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Drug | Intervention Group |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No
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PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
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Clinical and Inflammatory Outcomes of Regenerative Endodontic Treatment Using Injectable Platelet-Rich Fibrin in Mature Necrotic Teeth With Chronic Apical Periodontitis.
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Early Healing of Apical Periodontitis After Root Canal Treatment With Bioceramic and Calcium Hydroxide Medicaments: Evaluation Using PAI and ImageJ
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saline 0.9% (1.5-2.5°C) in people with Periapical Diseases, run by Islamabad Medical and Dental College at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aroosa Bakhtawar, BDS (03379248459, bakhtawararoosa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the reduction of postoperative pain (time frame: 24-48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.