CryotherapyNCT05722704
Effect of Cryotherapy on Post-endodontic Pain
A study testing Cryotherapy and Occlusal reduction in people with Cryotherapy, run by Gulf Medical University at 1 site in United Arab Emirates.
Trial summary
The goal of this clinical trial is to compare Cryotherapy with occlusal reduction in the reduction of post-endodontic pain in molars with symptomatic apical periodontitis. The main question it aims to answer is: Is there is a difference in post-endodontic pain intensity following cryotherapy or occlusal reduction in… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Cryotherapy
- What is being tested?
- Cryotherapy and Occlusal reduction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 12 Sep 2022to 12 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age: 18-70 years
- A patient diagnosed with symptomatic irreversible pulpitis/acute apical periodontitis
- require endodontic therapy
- Mandibular first molars that are diagnosed with symptomatic irreversible pulpitis/acute apical periodontitis
- Healthy patients without systemic disease
- Permanent mature first mandibular molars
Who cannot join
- Medically compromised patients
- Pregnant patients
- Teeth with incomplete apex formation
- Teeth with calcified canals
- Periapical abscess
- Patients on antibiotic therapy
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site
Gulf Medical University
Ajman, Ajman Emirate, 4184
About this study
Official title: Effect of Cryotherapy and Occlusal Reduction on Post-endodontic Pain in Patients With Symptomatic Apical Periodontitis
The goal of this clinical trial is to compare Cryotherapy with occlusal reduction in the reduction of post-endodontic pain in molars with symptomatic apical periodontitis. The main question it aims to answer is:
Is there is a difference in post-endodontic pain intensity following cryotherapy or occlusal reduction in patients with symptomatic apical periodontitis on mandibular first molars?
Participants will undergo root canal treatment including cryotherapy or post-operative occlusal reduction.
Researchers will compare [Cryotherapy, occlusal reduction, and no intervention] to see the intensity of post-endodontic pain.
Read the detailed description
The study will be conducted on 60 first mandibular molars; with 20 first mandibular molars in each group (n=20). The patient will be asked to pick an opaque sealed envelope that will contain a number from 1 to 3. The resultant number will determine in which group the participants will be placed. Double blinding will be maintained in this study as the operator and the patients will not be aware of their group/used root canal irrigant.
Group I : normal room temperature saline irrigation protocol without occlusal reduction.
Group II : normal room temperature saline irrigation protocol with occlusal reduction.
Group III : final irrigation with cold saline (2.5 C°- 4 C°) without occlusal reduction.
Procedural steps:
- Vitality will be assessed using cold tests and electric pulp testing before the procedure is carried out. Besides, mobility, palpation, and percussion tests will be done to assess periapical health. In order to ensure that the cold and electrical pulp tests are working, and a response is elicited, both tests will be carried out on patients not included in the study.
- All the patients will receive local anesthesia: 2% lidocaine with 1:100,000 epinephrine.
- Each tooth will be isolated using a rubber dam, and the access cavity will be prepared using a round bur (no.4) and tapered fissure diamond bur under copious water.
- After removal of coronal pulp tissues using a sterile excavator, the working length will be determined with stainless steel hand K-files size #10 and the use of an apex locator and confirmed using intraoral periapical radiographs.
- Hand instrumentation to 15-size K files.
- All the canals will be prepared using ProTaper Gold rotary files till the master apical file F2.
- Apical patency will be maintained throughout the shaping procedure using the #10 file between each instrument.
- All the canals will be irrigated with 10 mL of 3% NaOCl between each file during the whole preparation procedure.
- In group I the root canals will be obturated directly after preparation.
- In group II occlusal reduction will be performed after root canal preparation.
- For group III the root canals will be irrigated for 5 min using 20 ml cryo-treated saline maintained at a temperature of 2°C-4°C.
- After completion of cleaning and shaping dried using appropriate size paper points and the canals will be obturated using gutta-percha, and restored by permanent composite restoration.
- Conditions
- Cryotherapy
- Being tested
- Cryotherapy, Occlusal reduction
- Keywords
- Post endodontic pain, Cryotherapy, Occlusal reduction, Root canal treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryotherapyProcedure or surgery
Final irrigation with cold saline (2.5C-4C) without occlusal reduction
Occlusal reductionProcedure or surgery
Reduction of the functional and non-functional cusps
| Study group | Role | What they receive |
|---|---|---|
| Cryotherapy | Experimental | Final irrigation with cold saline (2.5C-4C) without occlusal reduction Receives: Procedure: Cryotherapy |
| Occlusal reduction | Active comparator | Normal room temperature saline irrigation protocol with occlusal reduction Receives: Procedure: Occlusal reduction |
| Control | No intervention | Normal room temperature saline irrigation protocol without occlusal reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Level of Post-endodontic Pain
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)
Measured: 6 hours
The Level of Post-endodontic Pain
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)
Measured: 24 hours
The Level of Post-endodontic Pain
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)
Measured: 48 hours
The Level of Post-endodontic Pain
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start12 Sep 2022
- Primary completion12 Sep 2023
- Study completion12 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CryotherapyStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulf Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722704
- Sponsor's protocol ID
- IRB/COD/STD/14/May-2022
- Status last verified
- Nov 2024
- First submitted
- 23 Jan 2023
- Last updated
- 6 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cryotherapy and Occlusal Reduction on Post-endodontic Pain in Patients With Symptomatic Apical Periodontitis
- ClinicalTrials.gov ID
- NCT05722704
- Acronym / sponsor ID
- IRB/COD/STD/14/May-2022
- Conditions
- Cryotherapy
- Keywords
- Post endodontic pain, Cryotherapy, Occlusal reduction, Root canal treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Gulf Medical UniversityUniversity, hospital or other
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 12 Sep 2023 (actual)
- Study completion
- 12 Dec 2023 (actual)
- First posted
- 10 Feb 2023 (actual)
- Results
- Posted 24 Dec 2024
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 compare Cryotherapy with occlusal reduction in the reduction of post-endodontic pain in molars with symptomatic apical periodontitis. The main question it aims to answer is:
Is there is a difference in post-endodontic pain intensity following cryotherapy or occlusal reduction in patients with symptomatic apical periodontitis on mandibular first molars?
Participants will undergo root canal treatment including cryotherapy or post-operative occlusal reduction.
Researchers will compare [Cryotherapy, occlusal reduction, and no intervention] to see the intensity of post-endodontic pain.
Detailed description
The study will be conducted on 60 first mandibular molars; with 20 first mandibular molars in each group (n=20). The patient will be asked to pick an opaque sealed envelope that will contain a number from 1 to 3. The resultant number will determine in which group the participants will be placed. Double blinding will be maintained in this study as the operator and the patients will not be aware of their group/used root canal irrigant.
Group I : normal room temperature saline irrigation protocol without occlusal reduction.
Group II : normal room temperature saline irrigation protocol with occlusal reduction.
Group III : final irrigation with cold saline (2.5 C°- 4 C°) without occlusal reduction.
Procedural steps:
- Vitality will be assessed using cold tests and electric pulp testing before the procedure is carried out. Besides, mobility, palpation, and percussion tests will be done to assess periapical health. In order to ensure that the cold and electrical pulp tests are working, and a response is elicited, both tests will be carried out on patients not included in the study.
- All the patients will receive local anesthesia: 2% lidocaine with 1:100,000 epinephrine.
- Each tooth will be isolated using a rubber dam, and the access cavity will be prepared using a round bur (no.4) and tapered fissure diamond bur under copious water.
- After removal of coronal pulp tissues using a sterile excavator, the working length will be determined with stainless steel hand K-files size #10 and the use of an apex locator and confirmed using intraoral periapical radiographs.
- Hand instrumentation to 15-size K files.
- All the canals will be prepared using ProTaper Gold rotary files till the master apical file F2.
- Apical patency will be maintained throughout the shaping procedure using the #10 file between each instrument.
- All the canals will be irrigated with 10 mL of 3% NaOCl between each file during the whole preparation procedure.
- In group I the root canals will be obturated directly after preparation.
- In group II occlusal reduction will be performed after root canal preparation.
- For group III the root canals will be irrigated for 5 min using 20 ml cryo-treated saline maintained at a temperature of 2°C-4°C.
- After completion of cleaning and shaping dried using appropriate size paper points and the canals will be obturated using gutta-percha, and restored by permanent composite restoration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cryotherapy | Experimental | Procedure: CryotherapyFinal irrigation with cold saline (2.5C-4C) without occlusal reduction |
| Occlusal reduction | Active comparator | Procedure: Occlusal reductionNormal room temperature saline irrigation protocol with occlusal reduction |
| Control | No intervention | –Normal room temperature saline irrigation protocol without occlusal reduction |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age: 18-70 years
- A patient diagnosed with symptomatic irreversible pulpitis/acute apical periodontitis
- require endodontic therapy
- Mandibular first molars that are diagnosed with symptomatic irreversible pulpitis/acute apical periodontitis
- Healthy patients without systemic disease
Key exclusion criteria (6 listed)
- Medically compromised patients
- Pregnant patients
- Teeth with incomplete apex formation
- Teeth with calcified canals
- Periapical abscess
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 |
|---|---|---|
| CryotherapyFinal irrigation with cold saline (2.5C-4C) without occlusal reduction | Procedure or surgery | Cryotherapy |
| Occlusal reductionReduction of the functional and non-functional cusps | Procedure or surgery | Occlusal reduction |
Primary outcome
The Level of Post-endodontic Pain
Time frame: 6 hours
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)
The Level of Post-endodontic Pain
Time frame: 24 hours
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)
The Level of Post-endodontic Pain
Time frame: 48 hours
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)
The Level of Post-endodontic Pain
Time frame: 72 hours
Evaluation of the pain intensity using the Visual Analogue Scale. The Visual Analogue Scale measures pain intensity. The Visual Analogue Scale consists of a 10cm line, with two endpoints representing 0 ('no pain') and 10 ('pain as bad as it could possibly be)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Cryotherapy
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Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
Not yet recruitingPhase 3
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
RecruitingObservational study
A Study to Evaluate Treating Watery Noses With Cryotherapy in the Clinic Setting. This is Cold Therapy, Freezing the Issues at the Back of the Nose to Ease Symptoms.
Chronic Rhinitis
Not yet recruitingPhase 3
Interest of Cryotherapy in Reducing Pain During Radial Arterial Blood Sampling
Chronic Respiratory Diseases
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryotherapy and Occlusal reduction in people with Cryotherapy, run by Gulf Medical University at 1 site in United Arab Emirates.
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 6 inclusion and 6 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 Oct 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 United Arab Emirates. 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?
Yes. Results are posted in the registry (first posted 24 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Level of Post-endodontic Pain (time frame: 6 hours). The study lists 4 primary outcomes in all. 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 6 Oct 2026.