Symptomatic Irreversible PulpitisPhase 1NCT05341999
Effect of Cryotherapy Versus Post-operative Ibuprofen Medication on Post-operative Pain in Mandibular Molar Teeth With Symptomatic Irreversible Pulpitis
A Phase 1 study testing cold saline (cryotherapy), Ibuprofen 400 mg and Final irrigation with normal saline in people with Symptomatic Irreversible Pulpitis, run by Cairo University.
Trial summary
Evaluation of the effect of cryotherapy versus post-operative ibuprofen medication on post-operative pain in mandibular molar teeth with symptomatic irreversible pulpitis . a new technique was proposed to utilize the effect of cold saline on reducing the inflammatory process in the tissue, the so-called cryotherapy. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Symptomatic Irreversible Pulpitis
- What is being tested?
- cold saline (cryotherapy), Ibuprofen 400 mg and Final irrigation with normal saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Apr 2022to May 2023
- Phase
- Phase 1
- 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 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- Medically compromised patients having significant systemic disorders including cardiovascular, respiratory, and gastrointestinal diseases (ASA II, III or IV).
- History of intolerance to NSAIDS.
- Patients with two or more adjacent teeth requiring endodontic treatment.
- External root resorption.
- Internal root resorption.
- Vertical root fracture.
Show all 17Show fewer
- Periapical lesion.
- Pregnancy.
- Use of ibuprofen in the last 12 hour.
- Bleeding disorder.
- Long term corticosteroid use. 10
- Mobility Grade II or III.
- Pocket depth more than 5mm.
- Previous root canal therapy.
- Non-restorability.
- TMJ problems, bruxism, clenching or traumatic occlusion.
- Inability to perceive the given instructions.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of the Effect of Cryotherapy Versus Post-operative Ibuprofen Medication on Post-operative Pain in Mandibular Molar Teeth With Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial
Evaluation of the effect of cryotherapy versus post-operative ibuprofen medication on post-operative pain in mandibular molar teeth with symptomatic irreversible pulpitis .
a new technique was proposed to utilize the effect of cold saline on reducing the inflammatory process in the tissue, the so-called cryotherapy.
Read the detailed description
PICO/
Population: Molar teeth with symptomatic irreversible pulpitis. Intervention I: Final irrigation with cold saline (cryotherapy). Intervention II: Ibuprofen post-operative medication.
Control: Final irrigation with normal saline, and no post-operative medication. Outcome: Post- operative pain.
Sequence of Procedural steps:
- Full medical and dental history will be obtained from all the patients .
- Thorough clinical and radiographic examination for the tooth to be treated will be done.
- The tooth will be anaesthetized and Access cavity will be performed.
- The canals will be thoroughly irrigated using 3ml syringe of Sodium hypochlorite after every instrument.
- Canals will be dried using sterile paper points.
- In the intervention group 1, cryotherapy irrigation will be done using 20ml of 2.5°C cold saline for 5 min, the cold saline will be stored in an icebox with a thermometer calibrated at 2.5°C.
- In the intervention group 2, the patients will be prescribed ibuprofen medication as a single dose immediately after completion of root canal treatment.
- In the control group, final irrigation will be done using normal saline at room temperature.
- Canals will be dried using sterile paper points, and then filled with gutta percha cones corresponding to the same size of the final shaping file and sealed with sealer.
- The access cavity will then be closed with temporary filling.
- Post-operative instructions will be given to all patients. • The patient will be asked to rate their pain level according to the given instructions and telecommunication will be scheduled after 3 days to collect the VAS scores and assess the outcome of the treatment. The patients who will be suffered from severe pain, analgesic will be prescribed.
- Conditions
- Symptomatic Irreversible Pulpitis
- Being tested
- cold saline (cryotherapy), Ibuprofen 400 mg, Final irrigation with normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cold saline (cryotherapy)Other
using 20ml of 2.5°C cold saline for 5 min
Ibuprofen 400 mgDrug
patients will be prescribed ibuprofen medication as a single dose immediately after completion of root canal treatment.
Final irrigation with normal salineOther
final irrigation will be done using normal saline at room temperature.
| Study group | Role | What they receive |
|---|---|---|
| Final irrigation with cold saline (cryotherapy). | Experimental | 20ml of 2.5°C cold saline for 5 min Receives: Other: cold saline (cryotherapy) |
| Ibuprofen post-operative medication. | Experimental | a single dose of Ibuprofen 400 mg immediately after completion of root canal treatment Receives: Drug: Ibuprofen 400 mg |
| Final irrigation with normal saline, and no post-operative medication | Active comparator | final irrigation will be done using normal saline at room temperature. Receives: Other: Final irrigation with normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain
The pain will be recorded using the modified visual analogue scale (VAS). • 0, "no pain"
- 1-3, "mild pain"
- 4-6, "moderate pain"
- 7-10, "severe pain" "10" being the most intense pain conceivable.
Measured: 6 hours post-operatively
Post-operative pain
The pain will be recorded using the modified visual analogue scale (VAS). • 0, "no pain"
- 1-3, "mild pain"
- 4-6, "moderate pain"
- 7-10, "severe pain" "10" being the most intense pain conceivable.
Measured: 24 hours post-operatively
Post-operative pain
The pain will be recorded using the modified visual analogue scale (VAS). • 0, "no pain"
- 1-3, "mild pain"
- 4-6, "moderate pain"
- 7-10, "severe pain" "10" being the most intense pain conceivable.
Measured: 48 hours post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study startApr 2022 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Symptomatic Irreversible PulpitisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yousef Hassan Mohammed Abuhelal, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05341999
- Sponsor's protocol ID
- ENDO3/3/5
- Status last verified
- Apr 2022
- First submitted
- 14 Apr 2022
- Last updated
- 22 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Cryotherapy Versus Post-operative Ibuprofen Medication on Post-operative Pain in Mandibular Molar Teeth With Symptomatic Irreversible Pulpitis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05341999
- Acronym / sponsor ID
- ENDO3/3/5
- Conditions
- Symptomatic Irreversible Pulpitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Apr 2022 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 22 Apr 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.
Evaluation of the effect of cryotherapy versus post-operative ibuprofen medication on post-operative pain in mandibular molar teeth with symptomatic irreversible pulpitis .
a new technique was proposed to utilize the effect of cold saline on reducing the inflammatory process in the tissue, the so-called cryotherapy.
Detailed description
PICO/
Population: Molar teeth with symptomatic irreversible pulpitis. Intervention I: Final irrigation with cold saline (cryotherapy). Intervention II: Ibuprofen post-operative medication.
Control: Final irrigation with normal saline, and no post-operative medication. Outcome: Post- operative pain.
Sequence of Procedural steps:
- Full medical and dental history will be obtained from all the patients .
- Thorough clinical and radiographic examination for the tooth to be treated will be done.
- The tooth will be anaesthetized and Access cavity will be performed.
- The canals will be thoroughly irrigated using 3ml syringe of Sodium hypochlorite after every instrument.
- Canals will be dried using sterile paper points.
- In the intervention group 1, cryotherapy irrigation will be done using 20ml of 2.5°C cold saline for 5 min, the cold saline will be stored in an icebox with a thermometer calibrated at 2.5°C.
- In the intervention group 2, the patients will be prescribed ibuprofen medication as a single dose immediately after completion of root canal treatment.
- In the control group, final irrigation will be done using normal saline at room temperature.
- Canals will be dried using sterile paper points, and then filled with gutta percha cones corresponding to the same size of the final shaping file and sealed with sealer.
- The access cavity will then be closed with temporary filling.
- Post-operative instructions will be given to all patients. • The patient will be asked to rate their pain level according to the given instructions and telecommunication will be scheduled after 3 days to collect the VAS scores and assess the outcome of the treatment. The patients who will be suffered from severe pain, analgesic will be prescribed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Final irrigation with cold saline (cryotherapy). | Experimental | Other: cold saline (cryotherapy)20ml of 2.5°C cold saline for 5 min |
| Ibuprofen post-operative medication. | Experimental | Drug: Ibuprofen 400 mga single dose of Ibuprofen 400 mg immediately after completion of root canal treatment |
| Final irrigation with normal saline, and no post-operative medication | Active comparator | Other: Final irrigation with normal salinefinal irrigation will be done using normal saline at room temperature. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (17 listed)
- Medically compromised patients having significant systemic disorders including cardiovascular, respiratory, and gastrointestinal diseases (ASA II, III or IV).
- History of intolerance to NSAIDS.
- Patients with two or more adjacent teeth requiring endodontic treatment.
- External root resorption.
- Internal root resorption.
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 saline (cryotherapy)using 20ml of 2.5°C cold saline for 5 min | Other | Final irrigation with cold saline (cryotherapy). |
| Ibuprofen 400 mgpatients will be prescribed ibuprofen medication as a single dose immediately after completion of root canal treatment. | Drug | Ibuprofen post-operative medication. |
| Final irrigation with normal salinefinal irrigation will be done using normal saline at room temperature. | Other | Final irrigation with normal saline, and no post-operative medication |
Primary outcome
Post-operative pain
Time frame: 6 hours post-operatively
The pain will be recorded using the modified visual analogue scale (VAS). • 0, "no pain" * 1-3, "mild pain" * 4-6, "moderate pain" * 7-10, "severe pain" "10" being the most intense pain conceivable.
Post-operative pain
Time frame: 24 hours post-operatively
The pain will be recorded using the modified visual analogue scale (VAS). • 0, "no pain" * 1-3, "mild pain" * 4-6, "moderate pain" * 7-10, "severe pain" "10" being the most intense pain conceivable.
Post-operative pain
Time frame: 48 hours post-operatively
The pain will be recorded using the modified visual analogue scale (VAS). • 0, "no pain" * 1-3, "mild pain" * 4-6, "moderate pain" * 7-10, "severe pain" "10" being the most intense pain conceivable.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing cold saline (cryotherapy), Ibuprofen 400 mg and Final irrigation with normal saline in people with Symptomatic Irreversible Pulpitis, run by Cairo University.
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 0 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yousef H Abuhelal, Master (+201033054851, yousefhassan@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain (time frame: 6 hours post-operatively). The study lists 3 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 22 Apr 2022.