Post Operative Pain ControlEarly Phase 1NCT06894069
Intracanal Dexamethasone Extrusion and Postoperative Endodontic Pain
A Early Phase 1 study testing Dexamethasone in people with Post Operative Pain Control and Endodontic Treatment, run by University of Jordan.
Trial summary
The aim of this research is to assess the effect of intentionally extruding a corticosteroid intracanal solution into the periapical tissues on the postoperative pain after root canal treatment in patients with symptomatic irreversible pulpitis and symptomatic apical periodontitis (SIP/SAP). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Post Operative Pain Control, Endodontic Treatment
- What is being tested?
- Dexamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Mar 2025to May 2025
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A diagnosis of irreversible pulpits with symptomatic apical periodontitis
- Adult patients (aged 18 - 70)
- Healthy patients or those with a well-controlled disease (ASA I \& II)
Who cannot join
- A diagnosis of necrotic pulp, or normal apical tissues
- Patients with a severe systemic disease (ASA III or higher)
- Patients who received analgesics12 hours before presentation
- Previously treated/initiated Endodontics treatment on the same tooth
- Unopposed teeth
- Third molar teeth
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- Non-restorable teeth
- Periodontally compromised teeth
- Pregnant or lactating patients
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Ahmad M El Ma'aita contact
About this study
Official title: Effect of Intentional Extrusion of an Intracanal Corticosteroid Solution on Post Endodontic Treatment Pain: a Randomized Clinical Trial
The aim of this research is to assess the effect of intentionally extruding a corticosteroid intracanal solution into the periapical tissues on the postoperative pain after root canal treatment in patients with symptomatic irreversible pulpitis and symptomatic apical periodontitis (SIP/SAP). The main question it aims to answer: Is there an analgesic effect of extruding an intracanal solution of DXA into the periapical tissues in patients diagnosed with SIP/SAP? Researchers will compare dexamethasone to a placebo to see if the extrusion dexamethasone works in reducing post-endodontic treatment pain.
- Conditions
- Post Operative Pain Control, Endodontic Treatment
- Being tested
- Dexamethasone, Placebo
- Keywords
- Root canal treatment, Post-operative pain, Corticosteroids, Dexamethasone, Randomised controlled trial
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
a 2 ml solution of dexamethasone (3.3mg/ml) will be flushed in the root canal and intentionally extruded to the periradicular tissues to assess its potnetial sedative effect
PlaceboOther
2ml of normal saline will be used as placebo to be flushed and extruded through the canals to the periradicular tissues
| Study group | Role | What they receive |
|---|---|---|
| DXM | Experimental | Patients in this group will receive a standard root canal treatment but with the extra step of extruding a Dexamethasone (DXM) solution through the root canals to the periradicular tissues prior to obturation. Receives: Drug: Dexamethasone |
| Saline | Placebo comparator | Patients in this group will receive a standard root canal treatment with saline used as the final irrigating solution prior to obturation. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain following root canal treatment
The outcome measure is patient-reported pain following root canal treatment. Patients will be given a questionnaire to complete, on 4 different time intervals following the completion of their root canal treatment (12, 24, 48 and 72 h). For each time interval, patients will be asked to fill out:
- their perceived pain level on a standard 100mm visual-analogue scale, with pain values ranging from zero (no pain at all) and ascending gradually until 100 (worst imagined pain).
- Whether they needed to take any analgesics. In this case, details about the type, route, dose and timing of the analgesic taken will have to be filled out
Measured: at 12, 24, 48 and 72 hours after completing the treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2025
- Study startMar 2025 (estimated)
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Pain ControlStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Jordan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Renad Hazem Khanfer, University of Jordan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06894069
- Sponsor's protocol ID
- 10/2023/ 32001
- Status last verified
- Mar 2025
- First submitted
- 23 Jan 2025
- Last updated
- 26 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intentional Extrusion of an Intracanal Corticosteroid Solution on Post Endodontic Treatment Pain: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06894069
- Acronym / sponsor ID
- 10/2023/ 32001
- Conditions
- Post Operative Pain Control, Endodontic Treatment
- Keywords
- Root canal treatment, Post-operative pain, Corticosteroids, Dexamethasone, Randomised controlled trial
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of JordanUniversity, hospital or other
- Study start
- Mar 2025 (estimated)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 25 Mar 2025 (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 this research is to assess the effect of intentionally extruding a corticosteroid intracanal solution into the periapical tissues on the postoperative pain after root canal treatment in patients with symptomatic irreversible pulpitis and symptomatic apical periodontitis (SIP/SAP). The main question it aims to answer: Is there an analgesic effect of extruding an intracanal solution of DXA into the periapical tissues in patients diagnosed with SIP/SAP? Researchers will compare dexamethasone to a placebo to see if the extrusion dexamethasone works in reducing post-endodontic treatment pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DXM | Experimental | Drug: DexamethasonePatients in this group will receive a standard root canal treatment but with the extra step of extruding a Dexamethasone (DXM) solution through the root canals to the periradicular tissues prior to obturation. |
| Saline | Placebo comparator | Other: PlaceboPatients in this group will receive a standard root canal treatment with saline used as the final irrigating solution prior to obturation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A diagnosis of irreversible pulpits with symptomatic apical periodontitis
- Adult patients (aged 18 - 70)
- Healthy patients or those with a well-controlled disease (ASA I \& II)
Key exclusion criteria (9 listed)
- A diagnosis of necrotic pulp, or normal apical tissues
- Patients with a severe systemic disease (ASA III or higher)
- Patients who received analgesics12 hours before presentation
- Previously treated/initiated Endodontics treatment on the same tooth
- Unopposed teeth
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 |
|---|---|---|
| Dexamethasonea 2 ml solution of dexamethasone (3.3mg/ml) will be flushed in the root canal and intentionally extruded to the periradicular tissues to assess its potnetial sedative effect | Drug | DXM |
| Placebo2ml of normal saline will be used as placebo to be flushed and extruded through the canals to the periradicular tissues | Other | Saline |
Primary outcome
Post-operative pain following root canal treatment
Time frame: at 12, 24, 48 and 72 hours after completing the treatment
The outcome measure is patient-reported pain following root canal treatment. Patients will be given a questionnaire to complete, on 4 different time intervals following the completion of their root canal treatment (12, 24, 48 and 72 h). For each time interval, patients will be asked to fill out: 1. their perceived pain level on a standard 100mm visual-analogue scale, with pain values ranging from zero (no pain at all) and ascending gradually until 100 (worst imagined pain). 2. Whether they needed to take any analgesics. In this case, details about the type, route, dose and timing of the analgesic taken will have to be filled out
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2025.
- Individual participant dataSharing planned: Yes
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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.
Ahmad M El Ma'aita contact
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Dexamethasone in people with Post Operative Pain Control and Endodontic Treatment, run by University of Jordan.
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 3 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: opening soon, as of the sponsor's last update on 26 Mar 2025. 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. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Renad H Khanfer (+962795101571, renad_hazem@hotmai.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative pain following root canal treatment (time frame: at 12, 24, 48 and 72 hours after completing the treatment). 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 26 Mar 2025.