PremedicationPhase 3NCT06671743
Premedication on Post-endodontic Pain
A Phase 3 study testing Root canal treatment in people with Premedication, run by Gulf Medical University at 1 site in United Arab Emirates.
Trial summary
The goal of this clinical trial is to compare the efficacy of preoperative administration of alpha-chemo-trypsin, ibuprofen, and acetaminophen in managing post-endodontic pain in patients with symptomatic irreversible pulpitis. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Premedication
- What is being tested?
- Root canal treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Sep 2024to 1 Nov 2026
- Phase
- Phase 3
- 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 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Eligibility for root canal treatment Patients diagnosed with symptomatic irreversible pulpitis with normal apical tissue in mandibular molars
Who cannot join
- • Patient under any medication or analgesic intake for pain management.
- Patients with any systemic health issues
- Patient allergies to trypsin-chymotrypsin, ibuprofen, and paracetamol
- Pregnancy.
- Non-restorable teeth.
- Immature roots.
- Calcifications.
- Resorptions.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Arab Emirates1 site, 1 recruiting
- Recruiting
Gulf Medical University
Ajman, 4184
Elsewify, +971585078876, dr.tarek@gmu.ac.ae
Elsewify, BDS, MDS, DDS
About this study
Official title: Effect of Premedication on Post-endodontic Pain in Patients With Symptomatic Irreversible Pulpitis, a Triple-blinded Randomized Control Trial
The goal of this clinical trial is to compare the efficacy of preoperative administration of alpha-chemo-trypsin, ibuprofen, and acetaminophen in managing post-endodontic pain in patients with symptomatic irreversible pulpitis. The main question it aims to answer is:
What is the efficacy of preoperative administration of alpha-chemo-trypsin, ibuprofen, and acetaminophen in managing post-endodontic pain in patients with symptomatic irreversible pulpitis? Participants will undergo root canal treatment after premedication. Researchers will compare [alpha-chemo-trypsin, ibuprofen, and acetaminophen] to see the intensity of post-endodontic pain.
- Conditions
- Premedication
- Being tested
- Root canal treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Root canal treatmentProcedure or surgery
History of presenting illness will be recorded and vitality testing will be done in addition to pre-operative radiograph.
Patient will read and sign the consent form. Pre-operative pain score will be recorded using visual analogue scale. The patient will take the preoperative medication 1 hour prior to the procedure.
The patient will receive 1 cartridge of LA with inferior alveolar nerve block (2% lidocaine 1:80000) and a rubber dam will be used for isolation.
Access cavity will be prepared and working length will be determined. Cleaning and shaping of the root canal system will be performed followed by obturation using a standardized protocol followed by final coronal restoration.
Postoperative pain score will be recorded at the 6, 12, 24, and 48 hours using visual analogue pain scale.
| Study group | Role | What they receive |
|---|---|---|
| trypsin-chymotrypsin | Experimental | Not described Receives: Procedure: Root canal treatment |
| Ibuprofen | Active comparator | Not described Receives: Procedure: Root canal treatment |
| paracetamol | Active comparator | Not described Receives: Procedure: Root canal treatment |
| placebo | Placebo comparator | Not described Receives: Procedure: Root canal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-endodontic pain score
Post operative pain score will be recorded using the visual analogue pain scale, where the patient will mark a point on a 10-cm line representing a continuum from 'no pain' to 'worst pain imaginable.
Measured: 6 hours
Post-endodontic pain score
Post operative pain score will be recorded using the visual analogue pain scale, where the patient will mark a point on a 10-cm line representing a continuum from 'no pain' to 'worst pain imaginable.
Measured: 12 hours
Post-endodontic pain score
Post operative pain score will be recorded using the visual analogue pain scale, where the patient will mark a point on a 10-cm line representing a continuum from 'no pain' to 'worst pain imaginable.
Measured: 24 hours
Post-endodontic pain score
Post operative pain score will be recorded using the visual analogue pain scale, where the patient will mark a point on a 10-cm line representing a continuum from 'no pain' to 'worst pain imaginable.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2024
- Study start1 Sep 2024
- Primary completion1 Jul 2026 (estimated)
- Study completion1 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PremedicationStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gulf Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06671743
- Sponsor's protocol ID
- IRB-COD-STD-22-JULY-2024
- Status last verified
- Nov 2024
- First submitted
- 30 Oct 2024
- Last updated
- 4 Nov 2024
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Premedication on Post-endodontic Pain in Patients With Symptomatic Irreversible Pulpitis, a Triple-blinded Randomized Control Trial
- ClinicalTrials.gov ID
- NCT06671743
- Acronym / sponsor ID
- IRB-COD-STD-22-JULY-2024
- Conditions
- Premedication
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Gulf Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- 1 Nov 2026 (estimated)
- First posted
- 4 Nov 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 clinical trial is to compare the efficacy of preoperative administration of alpha-chemo-trypsin, ibuprofen, and acetaminophen in managing post-endodontic pain in patients with symptomatic irreversible pulpitis. The main question it aims to answer is:
What is the efficacy of preoperative administration of alpha-chemo-trypsin, ibuprofen, and acetaminophen in managing post-endodontic pain in patients with symptomatic irreversible pulpitis? Participants will undergo root canal treatment after premedication. Researchers will compare [alpha-chemo-trypsin, ibuprofen, and acetaminophen] to see the intensity of post-endodontic pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| trypsin-chymotrypsin | Experimental | Procedure: Root canal treatment |
| Ibuprofen | Active comparator | Procedure: Root canal treatment |
| paracetamol | Active comparator | Procedure: Root canal treatment |
| placebo | Placebo comparator | Procedure: Root canal treatment |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Eligibility for root canal treatment Patients diagnosed with symptomatic irreversible pulpitis with normal apical tissue in mandibular molars
Key exclusion criteria (8 listed)
- • Patient under any medication or analgesic intake for pain management.
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 |
|---|---|---|
| Root canal treatmentHistory of presenting illness will be recorded and vitality testing will be done in addition to pre-operative radiograph. Patient will read and sign the consent form. Pre-operative pain score will be recorded using visual analogue scale. The patient will take the preoperative medication 1 hour prior to the procedure. The patient will receive 1 cartridge of LA with inferior alveolar nerve block (2% lidocaine 1:80000) and a rubber dam will be used for isolation. Access cavity will be prepared and working length will be determined. Cleaning and shaping of the root canal system will be performed followed by obturation using a standardized protocol followed by final coronal restoration. Postoperative pain score will be recorded at the 6, 12, 24, and 48 hours using visual analogue pain scale. | Procedure or surgery | Ibuprofen, paracetamol, placebo, trypsin-chymotrypsin |
Primary outcome
Post-endodontic pain score
Time frame: 6 hours
Post operative pain score will be recorded using the visual analogue pain scale, where the patient will mark a point on a 10-cm line representing a continuum from 'no pain' to 'worst pain imaginable.
Post-endodontic pain score
Time frame: 12 hours
Post operative pain score will be recorded using the visual analogue pain scale, where the patient will mark a point on a 10-cm line representing a continuum from 'no pain' to 'worst pain imaginable.
Post-endodontic pain score
Time frame: 24 hours
Post operative pain score will be recorded using the visual analogue pain scale, where the patient will mark a point on a 10-cm line representing a continuum from 'no pain' to 'worst pain imaginable.
Post-endodontic pain score
Time frame: 48 hours
Post operative pain score will be recorded using the visual analogue pain scale, where the patient will mark a point on a 10-cm line representing a continuum from 'no pain' to 'worst pain imaginable.
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 4 Nov 2024.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Root canal treatment in people with Premedication, 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 1 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 4 Nov 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 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. 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?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Elsewify (+971585078876, dr.tarek@gmu.ac.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-endodontic pain score (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 4 Nov 2024.