Irreversible PulpitisNCT06427070
Effectiveness of Two Intracanal Irrigation Solutions
A study testing Irrigating solution in people with Irreversible Pulpitis, run by Misr University for Science and Technology.
Trial summary
The aim of the present clinical trial is to investigate and compare the effect of crayotherapy utilizing two intra-canal final irrigating solutions on postoperative pain. Read more about this study
- Who is it for?
- Ages 25 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- Irrigating solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- 23 May 2024to 1 Jun 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 25 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Case diagnosed as having symptomatic irreversible pulpitis with symptomatic apical periodontitis
- Patients requiring emergency RCT
- Pre-operative pain score 7 on Numerical Rating (NRS) scale
- Middle aged males (25-50)
- Medical profile ASA1
- Willing to sign the consent form
- Willing to answer our call for one week period
Who cannot join
- Females
- Medical conditions above ASA1
- Multi-rooted teeth
- Patients younger or older than (25-50)
About this study
Official title: Effectiveness of Two Intracanal Irrigation Solutions Delivered Through Cryotherapy on Post-Endodontic Pain Relieve. A Randomized Clinical Trial
The aim of the present clinical trial is to investigate and compare the effect of crayotherapy utilizing two intra-canal final irrigating solutions on postoperative pain.
Read the detailed description
- st: Comparison of pain reduction algorism after cryotherapy using the two tested irrigating materials
- nd. Number and frequency of analgesics taken for pain relief during one week postoperative
- Conditions
- Irreversible Pulpitis
- Being tested
- Irrigating solution
- Keywords
- Pulpitis, CHX, Saline
- Medical subject headings
- Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irrigating solutionOther
Also called Chlorohexidine
Saline, sodium hypochlorite, chlorohexidine
| Study group | Role | What they receive |
|---|---|---|
| Irrigating solutions | Experimental | Group 1 sodium hypochlorite Group 2 saline Group 3 chlorohexidine Receives: Other: Irrigating solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain scale
pain scale Comparison of the 2 selected irrigating solutions
Measured: 1 week
Analgesics Frequency
Frequency of analgesics for pain relief
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start23 May 2024 (estimated)
- Primary completion30 May 2024 (estimated)
- Study completion1 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Irreversible PulpitisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Misr University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manal Mohamed, Misr University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06427070
- Sponsor's protocol ID
- CHX 2024
- Status last verified
- May 2024
- First submitted
- 14 May 2024
- Last updated
- 23 May 2024
- Results posted
- No
- 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 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Two Intracanal Irrigation Solutions Delivered Through Cryotherapy on Post-Endodontic Pain Relieve. A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06427070
- Acronym / sponsor ID
- CHX 2024
- Conditions
- Irreversible Pulpitis
- Keywords
- Pulpitis, CHX, Saline
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Misr University for Science and TechnologyUniversity, hospital or other
- Study start
- 23 May 2024 (estimated)
- Primary completion
- 30 May 2024 (estimated)
- Study completion
- 1 Jun 2024 (estimated)
- First posted
- 23 May 2024 (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 aim of the present clinical trial is to investigate and compare the effect of crayotherapy utilizing two intra-canal final irrigating solutions on postoperative pain.
Detailed description
- st: Comparison of pain reduction algorism after cryotherapy using the two tested irrigating materials
- nd. Number and frequency of analgesics taken for pain relief during one week postoperative
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Irrigating solutions | Experimental | Other: Irrigating solutionGroup 1 sodium hypochlorite Group 2 saline Group 3 chlorohexidine |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Case diagnosed as having symptomatic irreversible pulpitis with symptomatic apical periodontitis
- Patients requiring emergency RCT
- Pre-operative pain score 7 on Numerical Rating (NRS) scale
- Middle aged males (25-50)
- Medical profile ASA1
Key exclusion criteria (4 listed)
- Females
- Medical conditions above ASA1
- Multi-rooted teeth
- Patients younger or older than (25-50)
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 |
|---|---|---|
| Irrigating solutionAlso: ChlorohexidineSaline, sodium hypochlorite, chlorohexidine | Other | Irrigating solutions |
Primary outcome
pain scale
Time frame: 1 week
pain scale Comparison of the 2 selected irrigating solutions
Analgesics Frequency
Time frame: 1 week
Frequency of analgesics for pain relief
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Irrigating solution in people with Irreversible Pulpitis, run by Misr University for Science and Technology.
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 7 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: status not confirmed, as of the sponsor's last update on 23 May 2024. 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.
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?
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?
pain scale (time frame: 1 week). The study lists 2 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 23 May 2024.