Postoperative PainNCT06457828
Effect of Apical Patency and Local Corticosteroid on Pain and Neuropeptides Release in Patients With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial
A study testing Non-corticosteroid injection and Corticosteroid injection in people with Postoperative Pain and Symptomatic Irreversible Pulpitis, run by Suez Canal University at 1 site in Egypt.
Trial summary
The goal of this randomized clinical trial is to learn the effect of using local corticosteroids and maintaining apical patency in reducing post-preparation pain in patients with acute irreversible pulpitis in molar teeth. Read more about this study
- Who is it for?
- Ages 21 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Symptomatic Irreversible Pulpitis
- What is being tested?
- Non-corticosteroid injection and Corticosteroid injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2021to Sep 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 21 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Symptomatic acute irreversible pulpitis in molar teeth.
- Normal periapical condition including periapical radiography with minimal widening of periodontal ligament.
- Normal probing depth.
- No medical condition.
- No contraindication for administration of corticosteroids and local anesthesia.
Who cannot join
- Facial or oral paresthesia.
- Pregnancy \& breastfeeding.
- Unrestorable tooth.
- Marginal periodontal disease.
- Presence of a crown on the tooth involved.
- Over instrumentation during root canal treatment.
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- Long-term use of corticosteroids.
- False-positive cases of sensibility test with necrosis discovered after gaining access to the tooth.
- Cases requiring intrapulpal injection to promote anesthesia.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Suez Canal University
Ismailia
Mustafa Sultan, +201111506890, sultan_mustafa@hotmail.com
About this study
The goal of this randomized clinical trial is to learn the effect of using local corticosteroids and maintaining apical patency in reducing post-preparation pain in patients with acute irreversible pulpitis in molar teeth. The main question it aims to answer is:
- How effective are using local corticosteroids and maintaining apical patency in reducing post-preparation pain in patients with acute irreversible pulpitis? Participants will be asked to fill a visual analogue scale to record their pain, after receiving a root canal treatment while using local corticosteroids or not as well as maintaining apical patency or not.
Researchers will compare the use of corticosteroids and maintaining apical patency in reducing post-operative pain.
- Being tested
- Non-corticosteroid injection, Corticosteroid injection
- Keywords
- Pulpitis, Postoperative Pain, VAS
- Medical subject headings
- Pain, Postoperative, Pulpitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-corticosteroid injectionProcedure or surgery
no infiltration injection of 0.7 ml of dexamethasone lateral to the involved tooth after anesthesia administration.
Corticosteroid injectionDrug
infiltration injection of 0.7 ml of dexamethasone lateral to the involved tooth after anesthesia administration.
| Study group | Role | What they receive |
|---|---|---|
| No apical patency | Sham comparator | Not described Receives: Procedure: Non-corticosteroid injection; Drug: Corticosteroid injection |
| Apical patency | Active comparator | Not described Receives: Procedure: Non-corticosteroid injection; Drug: Corticosteroid injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain
Patients were instructed to record their pain level using the Visual Analog Scale
Measured: 6, 12, 24, 48, 72 hour and 7 days postoperative intervals
Inflammatory markers
Gingival crevicular fluid samples were collected by periopaper for testing the level of IL-1β and IL-10
Measured: before treatment, after 3 days and after 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2024
- Study start1 Feb 2021
- Primary completionJun 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Suez Canal 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa M. Sultan, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06457828
- Sponsor's protocol ID
- 291/2020
- Status last verified
- Jun 2024
- First submitted
- 8 Jun 2024
- Last updated
- 13 Jun 2024
- 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 13 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Apical Patency and Local Corticosteroid on Pain and Neuropeptides Release in Patients With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06457828
- Acronym / sponsor ID
- 291/2020
- Keywords
- Pulpitis, Postoperative Pain, VAS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 13 Jun 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 goal of this randomized clinical trial is to learn the effect of using local corticosteroids and maintaining apical patency in reducing post-preparation pain in patients with acute irreversible pulpitis in molar teeth. The main question it aims to answer is:
- How effective are using local corticosteroids and maintaining apical patency in reducing post-preparation pain in patients with acute irreversible pulpitis? Participants will be asked to fill a visual analogue scale to record their pain, after receiving a root canal treatment while using local corticosteroids or not as well as maintaining apical patency or not.
Researchers will compare the use of corticosteroids and maintaining apical patency in reducing post-operative pain.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No apical patency | Sham comparator | Procedure: Non-corticosteroid injection, Drug: Corticosteroid injection |
| Apical patency | Active comparator | Procedure: Non-corticosteroid injection, Drug: Corticosteroid injection |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Symptomatic acute irreversible pulpitis in molar teeth.
- Normal periapical condition including periapical radiography with minimal widening of periodontal ligament.
- Normal probing depth.
- No medical condition.
- No contraindication for administration of corticosteroids and local anesthesia.
Key exclusion criteria (9 listed)
- Facial or oral paresthesia.
- Pregnancy \& breastfeeding.
- Unrestorable tooth.
- Marginal periodontal disease.
- Presence of a crown on the tooth involved.
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 |
|---|---|---|
| Non-corticosteroid injectionno infiltration injection of 0.7 ml of dexamethasone lateral to the involved tooth after anesthesia administration. | Procedure or surgery | Apical patency, No apical patency |
| Corticosteroid injectioninfiltration injection of 0.7 ml of dexamethasone lateral to the involved tooth after anesthesia administration. | Drug | Apical patency, No apical patency |
Primary outcome
Post-operative pain
Time frame: 6, 12, 24, 48, 72 hour and 7 days postoperative intervals
Patients were instructed to record their pain level using the Visual Analog Scale
Inflammatory markers
Time frame: before treatment, after 3 days and after 7 days
Gingival crevicular fluid samples were collected by periopaper for testing the level of IL-1β and IL-10
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-corticosteroid injection and Corticosteroid injection in people with Postoperative Pain and Symptomatic Irreversible Pulpitis, run by Suez Canal University at 1 site in Egypt.
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 9 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 13 Jun 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
Contact Mustafa Sultan (+201111506890, sultan_mustafa@hotmail.com), 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, 12, 24, 48, 72 hour and 7 days postoperative intervals). 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 13 Jun 2024.