Dental Pulp NecrosesNCT05611736
Effects of Intracanal Cryotherapy on Endodontic Postoperative Pain
A study testing cold saline and saline in people with Dental Pulp Necroses and Apical Periodontitis, run by Qassim University at 1 site in Saudi Arabia.
Trial summary
The goal of this clinical trial is to evaluate the effect of cold saline (2.5 degrees Celsius) irrigation on postoperative pain in patients who require root canal treatment in molar teeth because of dead dental pulp and infection around the apex of the root of the involved teeth. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dental Pulp Necroses, Apical Periodontitis, Post Operative Pain
- What is being tested?
- cold saline and saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jun 2022to 14 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy patients
- Patients with maxillary or mandibular molar teeth that require root canal treatment
- The diagnosis of pulp necrosis
- The presence of symptomatic apical periodontitis
- The presence of normal occlusion
Who cannot join
- Previously done root canal treatment
- Pregnancy
- Presence of any systemic disease or allergic reactions
- Use of any analgesic or antibiotic medications within the past three days
- Sinus tract or local gingival swelling around the affected tooth
- Periodontal pocket greater than 3 mm around the affected tooth
Show all 12Show fewer
- Severe periodontal disease
- Internal or external root resorption
- Broken files
- Over instrumentation
- Incomplete filling of the root canal
- Overfilling of the root canal
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Muhammad Zubair Ahmad
Ar Rass, Al-Qassim Region, 58883
About this study
Official title: Effects of Intracanal Cryotherapy on Postoperative Pain in Necrotic Teeth With Symptomatic Apical Periodontitis: A Randomized Controlled Clinical Trial
The goal of this clinical trial is to evaluate the effect of cold saline (2.5 degrees Celsius) irrigation on postoperative pain in patients who require root canal treatment in molar teeth because of dead dental pulp and infection around the apex of the root of the involved teeth. This cold saline irrigation will be done after standard irrigation of the canal using a 5.25% sodium hypochlorite solution. The main questions it aims to answer are:
- Is there any difference in postoperative pain when final irrigation is performed using a cold saline solution compared to the irrigation using the saline solution at room temperature in patients who require dental root canal treatment of molar teeth?
- Because of cold saline irrigation, what type of adverse event/s may result?
Read more
Participants will be asked to fill out a questionnaire before the start of the root canal treatment and record the preoperative pain using the visual analog scale (VAS). Root canal treatment will be completed in one visit. The standard procedure of root canal treatment will be followed, including irrigation of the canal using 5.25% sodium hypochlorite. As a final irrigation, either cold saline solution or a normal saline solution at room temperature will be used. The participants will be asked to fill out another questionnaire and record the presence, duration, and intensity of postoperative pain, and if painkiller medicine was taken immediately after completion of root canal treatment and at 6 hours, 12 hours, 72 hours, and 1-week intervals.
The researcher will compare the effect of the final irrigation of a cold saline solution with that of a normal saline solution at room temperature on postoperative pain.
Read the detailed description
Postoperative pain in root canal therapy is multifactorial in nature, including changes in periapical pressure, microbial factors, inflammatory mediators, and psychological factors. Postoperative pain in endodontics between visits or after completion of the treatment is a major concern to both patients and operators. Teeth presented with preoperative pain, irreversible pulpitis, pulp necrosis, and apical periodontitis are the most susceptible to postoperative pain The pharmacological management of pain using medications such as nonsteroidal anti-inflammatory drugs, paracetamol, or corticosteroids, despite being relatively safe, can have side effects such as gastrointestinal intolerance and renal, hepatic, and respiratory disorders such as asthma which have been reported in the literature. To avoid these secondary effects, intracanal medications, laser, and cryotherapy have been suggested in the literature.
Physical and clinical evidence suggests that the application of cold may decrease pain through the mechanism of decreasing the conduction velocity of nerve signals, hemorrhage, edema, and local inflammation. An in vitro study showed that intracanal irrigation with cold saline at 2.5 degrees Celsius reduced the external root surface temperature by more than 10 degrees Celsius, which would be enough to produce the anti-inflammatory effect in peri-radicular tissues.
There are very few studies done to evaluate the effect of intracanal cryotherapy on postoperative pain in root canal therapy.
This clinical trial aims to assess if final irrigation using cold saline solution after standard chemo-mechanical preparation (root canal instrumentation and irrigation using 5.25% sodium hypochlorite) procedures results in any difference in the incidence and intensity of postoperative pain in patients presenting with molar teeth with necrosis of pulp and symptomatic apical periodontitis. This clinical trial will also assess the incidence of any adverse event as a result of cold saline irrigation.
- Being tested
- cold saline, saline
- Keywords
- Cryotherapy, endodontic pain, molar teeth, root canal treatment
- Medical subject headings
- Dental Pulp Necrosis, Periapical Periodontitis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cold salineOther
Also called cold normal saline
After standard chemo-mechanical preparation of the root canal, final irrigation will be performed using 20 milliliters of cold (at 2.5 degrees Celsius temperature) saline solution.
salineOther
Also called normal saline
After standard chemo-mechanical preparation of the root canal, final irrigation of the root canal will be done using normal saline solution at room temperature
| Study group | Role | What they receive |
|---|---|---|
| cold saline | Experimental | After standard chemo-mechanical preparation of the root canal, final irrigation will be performed using 20 milliliters of cold (at 2.5 degrees Celsius temperature) saline solution. Receives: Other: cold saline |
| saline | Active comparator | After standard chemo-mechanical preparation of the root canal, final irrigation of the root canal system will be performed using 20 milliliters of normal saline solution at room temperature. Receives: Other: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Postoperative pain will be measured using visual analog scale (VAS)
Measured: 6 hours postoperatively
Postoperative pain
Postoperative pain will be measured using visual analog scale (VAS)
Measured: 24 hours postoperatively
Postoperative pain
Postoperative pain will be measured using visual analog scale (VAS)
Measured: 72 hours postoperatively
Postoperative pain
Postoperative pain will be measured using visual analog scale (VAS)
Measured: 1 week postoperatively
adverse event
If any adverse event will occur, it will be recorded
Measured: during the irrigation procedure
adverse event
If any adverse event will occur, it will be recorded
Measured: immediately after the irrigation procedure
adverse event
If any adverse event will occur, it will be recorded
Measured: 6 hours postoperatively
adverse event
If any adverse event will occur, it will be recorded
Measured: 24 hours postoperatively
adverse event
If any adverse event will occur, it will be recorded
Measured: 72 hours postoperatively
adverse event
If any adverse event will occur, it will be recorded
Measured: 1 week postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Nov 2022
- Study start1 Jun 2022
- Primary completion14 Jan 2024
- Study completion14 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Dental Pulp NecrosesStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qassim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Zubair Ahmad, Qassim University
- Investigators
- Muhammad Zubair Ahmad, BDS, FCPS, Principal investigator, Qassim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05611736
- Sponsor's protocol ID
- 21-19-08
- Status last verified
- Feb 2024
- First submitted
- 28 Oct 2022
- Last updated
- 6 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Vera J, Ochoa-Rivera J, Vazquez-Carcano M, Romero M, Arias A, Sleiman P. Effect of Intracanal Cryotherapy on Reducing Root Surface Temperature. J Endod. 2015 Nov;41(11):1884-7. doi: 10.1016/j.joen.2015.08.009. Epub 2015 Oct 1.
PubMed 26433855Alharthi AA, Aljoudi MH, Almaliki MN, Almalki MA, Sunbul MA. Effect of intra-canal cryotherapy on post-endodontic pain in single-visit RCT: A randomized controlled trial. Saudi Dent J. 2019 Jul;31(3):330-335. doi: 10.1016/j.sdentj.2019.03.004. Epub 2019 Mar 14.
PubMed 31337936Fayyad DM, Abdelsalam N, Hashem N. Cryotherapy: A New Paradigm of Treatment in Endodontics. J Endod. 2020 Jul;46(7):936-942. doi: 10.1016/j.joen.2020.03.019. Epub 2020 May 6.
PubMed 32386857Sadaf D. Limited Quality Evidence Suggests that Application of Cryotherapy May Be Helpful in Reducing Postoperative Pain in Root Canal Therapy in Patients With Symptomatic Apical Periodontitis. J Evid Based Dent Pract. 2019 Jun;19(2):195-197. doi: 10.1016/j.jebdp.2019.05.005. Epub 2019 May 6.
PubMed 31326055Gundogdu EC, Arslan H. Effects of Various Cryotherapy Applications on Postoperative Pain in Molar Teeth with Symptomatic Apical Periodontitis: A Preliminary Randomized Prospective Clinical Trial. J Endod. 2018 Mar;44(3):349-354. doi: 10.1016/j.joen.2017.11.002. Epub 2018 Feb 3.
PubMed 29398090Sadaf D, Ahmad MZ, Onakpoya IJ. Effectiveness of Intracanal Cryotherapy in Root Canal Therapy: A Systematic Review and Meta-analysis of Randomized Clinical Trials. J Endod. 2020 Dec;46(12):1811-1823.e1. doi: 10.1016/j.joen.2020.08.022. Epub 2020 Sep 8.
PubMed 32916207Vera J, Ochoa J, Romero M, Vazquez-Carcano M, Ramos-Gregorio CO, Aguilar RR, Cruz A, Sleiman P, Arias A. Intracanal Cryotherapy Reduces Postoperative Pain in Teeth with Symptomatic Apical Periodontitis: A Randomized Multicenter Clinical Trial. J Endod. 2018 Jan;44(1):4-8. doi: 10.1016/j.joen.2017.08.038. Epub 2017 Nov 1.
PubMed 29079057Ahmad MZ. Effects of intracanal cryotherapy on postoperative pain in necrotic teeth with symptomatic apical periodontitis: a randomized controlled clinical trial. Front Dent Med. 2025 Apr 14;6:1543383. doi: 10.3389/fdmed.2025.1543383. eCollection 2025.
PubMed 40297278
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intracanal Cryotherapy on Postoperative Pain in Necrotic Teeth With Symptomatic Apical Periodontitis: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05611736
- Acronym / sponsor ID
- 21-19-08
- Keywords
- Cryotherapy, endodontic pain, molar teeth, root canal treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Qassim UniversityUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 14 Jan 2024 (actual)
- Study completion
- 14 Jan 2024 (actual)
- First posted
- 10 Nov 2022 (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.
The goal of this clinical trial is to evaluate the effect of cold saline (2.5 degrees Celsius) irrigation on postoperative pain in patients who require root canal treatment in molar teeth because of dead dental pulp and infection around the apex of the root of the involved teeth. This cold saline irrigation will be done after standard irrigation of the canal using a 5.25% sodium hypochlorite solution. The main questions it aims to answer are:
- Is there any difference in postoperative pain when final irrigation is performed using a cold saline solution compared to the irrigation using the saline solution at room temperature in patients who require dental root canal treatment of molar teeth?
- Because of cold saline irrigation, what type of adverse event/s may result?
Participants will be asked to fill out a questionnaire before the start of the root canal treatment and record the preoperative pain using the visual analog scale (VAS). Root canal treatment will be completed in one visit. The standard procedure of root canal treatment will be followed, including irrigation of the canal using 5.25% sodium hypochlorite. As a final irrigation, either cold saline solution or a normal saline solution at room temperature will be used. The participants will be asked to fill out another questionnaire and record the presence, duration, and intensity of postoperative pain, and if painkiller medicine was taken immediately after completion of root canal treatment and at 6 hours, 12 hours, 72 hours, and 1-week intervals.
The researcher will compare the effect of the final irrigation of a cold saline solution with that of a normal saline solution at room temperature on postoperative pain.
Detailed description
Postoperative pain in root canal therapy is multifactorial in nature, including changes in periapical pressure, microbial factors, inflammatory mediators, and psychological factors. Postoperative pain in endodontics between visits or after completion of the treatment is a major concern to both patients and operators. Teeth presented with preoperative pain, irreversible pulpitis, pulp necrosis, and apical periodontitis are the most susceptible to postoperative pain The pharmacological management of pain using medications such as nonsteroidal anti-inflammatory drugs, paracetamol, or corticosteroids, despite being relatively safe, can have side effects such as gastrointestinal intolerance and renal, hepatic, and respiratory disorders such as asthma which have been reported in the literature. To avoid these secondary effects, intracanal medications, laser, and cryotherapy have been suggested in the literature.
Physical and clinical evidence suggests that the application of cold may decrease pain through the mechanism of decreasing the conduction velocity of nerve signals, hemorrhage, edema, and local inflammation. An in vitro study showed that intracanal irrigation with cold saline at 2.5 degrees Celsius reduced the external root surface temperature by more than 10 degrees Celsius, which would be enough to produce the anti-inflammatory effect in peri-radicular tissues.
There are very few studies done to evaluate the effect of intracanal cryotherapy on postoperative pain in root canal therapy.
This clinical trial aims to assess if final irrigation using cold saline solution after standard chemo-mechanical preparation (root canal instrumentation and irrigation using 5.25% sodium hypochlorite) procedures results in any difference in the incidence and intensity of postoperative pain in patients presenting with molar teeth with necrosis of pulp and symptomatic apical periodontitis. This clinical trial will also assess the incidence of any adverse event as a result of cold saline irrigation.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cold saline | Experimental | Other: cold salineAfter standard chemo-mechanical preparation of the root canal, final irrigation will be performed using 20 milliliters of cold (at 2.5 degrees Celsius temperature) saline solution. |
| saline | Active comparator | Other: salineAfter standard chemo-mechanical preparation of the root canal, final irrigation of the root canal system will be performed using 20 milliliters of normal saline solution at room temperature. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy patients
- Patients with maxillary or mandibular molar teeth that require root canal treatment
- The diagnosis of pulp necrosis
- The presence of symptomatic apical periodontitis
- The presence of normal occlusion
Key exclusion criteria (12 listed)
- Previously done root canal treatment
- Pregnancy
- Presence of any systemic disease or allergic reactions
- Use of any analgesic or antibiotic medications within the past three days
- Sinus tract or local gingival swelling around the affected tooth
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 |
|---|---|---|
| cold salineAlso: cold normal salineAfter standard chemo-mechanical preparation of the root canal, final irrigation will be performed using 20 milliliters of cold (at 2.5 degrees Celsius temperature) saline solution. | Other | cold saline |
| salineAlso: normal salineAfter standard chemo-mechanical preparation of the root canal, final irrigation of the root canal will be done using normal saline solution at room temperature | Other | saline |
Primary outcome
Postoperative pain
Time frame: 6 hours postoperatively
Postoperative pain will be measured using visual analog scale (VAS)
Postoperative pain
Time frame: 24 hours postoperatively
Postoperative pain will be measured using visual analog scale (VAS)
Postoperative pain
Time frame: 72 hours postoperatively
Postoperative pain will be measured using visual analog scale (VAS)
Postoperative pain
Time frame: 1 week postoperatively
Postoperative pain will be measured using visual analog scale (VAS)
adverse event
Time frame: during the irrigation procedure
If any adverse event will occur, it will be recorded
adverse event
Time frame: immediately after the irrigation procedure
If any adverse event will occur, it will be recorded
adverse event
Time frame: 6 hours postoperatively
If any adverse event will occur, it will be recorded
adverse event
Time frame: 24 hours postoperatively
If any adverse event will occur, it will be recorded
adverse event
Time frame: 72 hours postoperatively
If any adverse event will occur, it will be recorded
adverse event
Time frame: 1 week postoperatively
If any adverse event will occur, it will be recorded
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Background: PubMed 26433855Vera J, Ochoa-Rivera J, Vazquez-Carcano M, Romero M, Arias A, Sleiman P. Effect of Intracanal Cryotherapy on Reducing Root Surface Temperature. J Endod. 2015 Nov;41(11):1884-7. doi: 10.1016/j.joen.2015.08.009. Epub 2015 Oct 1.
- Background: PubMed 31337936Alharthi AA, Aljoudi MH, Almaliki MN, Almalki MA, Sunbul MA. Effect of intra-canal cryotherapy on post-endodontic pain in single-visit RCT: A randomized controlled trial. Saudi Dent J. 2019 Jul;31(3):330-335. doi: 10.1016/j.sdentj.2019.03.004. Epub 2019 Mar 14.
- Background: PubMed 32386857Fayyad DM, Abdelsalam N, Hashem N. Cryotherapy: A New Paradigm of Treatment in Endodontics. J Endod. 2020 Jul;46(7):936-942. doi: 10.1016/j.joen.2020.03.019. Epub 2020 May 6.
- Background: PubMed 31326055Sadaf D. Limited Quality Evidence Suggests that Application of Cryotherapy May Be Helpful in Reducing Postoperative Pain in Root Canal Therapy in Patients With Symptomatic Apical Periodontitis. J Evid Based Dent Pract. 2019 Jun;19(2):195-197. doi: 10.1016/j.jebdp.2019.05.005. Epub 2019 May 6.
- Background: PubMed 29398090Gundogdu EC, Arslan H. Effects of Various Cryotherapy Applications on Postoperative Pain in Molar Teeth with Symptomatic Apical Periodontitis: A Preliminary Randomized Prospective Clinical Trial. J Endod. 2018 Mar;44(3):349-354. doi: 10.1016/j.joen.2017.11.002. Epub 2018 Feb 3.
- Background: PubMed 32916207Sadaf D, Ahmad MZ, Onakpoya IJ. Effectiveness of Intracanal Cryotherapy in Root Canal Therapy: A Systematic Review and Meta-analysis of Randomized Clinical Trials. J Endod. 2020 Dec;46(12):1811-1823.e1. doi: 10.1016/j.joen.2020.08.022. Epub 2020 Sep 8.
- Background: PubMed 29079057Vera J, Ochoa J, Romero M, Vazquez-Carcano M, Ramos-Gregorio CO, Aguilar RR, Cruz A, Sleiman P, Arias A. Intracanal Cryotherapy Reduces Postoperative Pain in Teeth with Symptomatic Apical Periodontitis: A Randomized Multicenter Clinical Trial. J Endod. 2018 Jan;44(1):4-8. doi: 10.1016/j.joen.2017.08.038. Epub 2017 Nov 1.
- Derived from this study: PubMed 40297278Ahmad MZ. Effects of intracanal cryotherapy on postoperative pain in necrotic teeth with symptomatic apical periodontitis: a randomized controlled clinical trial. Front Dent Med. 2025 Apr 14;6:1543383. doi: 10.3389/fdmed.2025.1543383. eCollection 2025.
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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. This study is not recruiting at the moment.
Muhammad Zubair Ahmad, BDS, FCPS principal investigator
Qassim University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cold saline and saline in people with Dental Pulp Necroses and Apical Periodontitis, run by Qassim University at 1 site in Saudi Arabia.
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 5 inclusion and 12 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: finished, as of the sponsor's last update on 6 Feb 2024. 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 Saudi Arabia. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (time frame: 6 hours postoperatively). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05611736, which also lists 8 linked publications.
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 6 Feb 2024.