Irreversible PulpitisPhase 2NCT05349929
Analgesic Effect of Anahil and Ibuprofen on Pain After Root Canal Therapy in Patients With Pulpitis of the Molars in Qazvin(a City in Iran)
A Phase 2 study testing Gelofen (generic name of Ibuprofen in Iran), Anahil ( generic name of Bromelain in Iran) and Root Canal Therapy in people with Irreversible Pulpitis, run by Qazvin University Of Medical Sciences.
Trial summary
Hypothesis: 0: The analgesic effect of Ibuprofen and Anahil would be the same in reducing the pain after root canal therapy. 1: Ibuprofen shows higher potency to reduce the pain after root canal therapy. 1: Anahil shows higher potency to reduce the pain after root canal therapy. 1. Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Irreversible Pulpitis
- What is being tested?
- Gelofen (generic name of Ibuprofen in Iran), Anahil ( generic name of Bromelain in Iran) and Root Canal Therapy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- May 2022to Dec 2022
- Phase
- Phase 2
- 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 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients report spontaneous pain of the first molar of mandible ranging from 50 to 100 mm on a VAS (0-100 mm)
- The dental pulp's condition is irreversible pulpitis and the tooth is reparable and need the root canal therapy
- No evidences of any lesions and lucency, PDL widening, loss of lamina dura in radiographic examination
- Patients aged 20 to 50 years from both genders
- Patients are not pregnant or breast-feeding
- Healthy periodontal status (no evidences of aggressive/chronic periodontal diseases)
Show all 14Show fewer
- No history of any systemic diseases (specially gastrointestinal and coagulation disorders)
- No history of allergic reaction to food nutrients (specially pineapple, celery, carrot, and fennel), NSAIDs and lidocaine
- No history of consuming the drugs interfere with NSAIDs, lidocaine and anticoagulants
- No use of other analgesic drugs within the last 6 hours
- Existence of no large restorations or crowns in treated tooth
- patients have no extreme fear of dental procedure
- Teeth with no evidence of infection or sinus tract
- Patients did not a previous RCT
Who cannot join
- Patients who leave the study because of any reasons
- Special anatomy of teeth (extra canals, severe root curvature, calcifications, open apex, C shape, fractures,..)
- Patients who are not able to tolerate the single-session treatment (time, tooth's situation,..)
- If the aspiration through IAN block injection is positive
- If the diagnosis of pulp status has changed to partial necrosis during access cavity preparation
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Comparison of the Analgesic Effect of Bromelain and Ibuprofen on Pain After Root Canal Treatment(A Clinical Trial Study)
Hypothesis:
0: The analgesic effect of Ibuprofen and Anahil would be the same in reducing the pain after root canal therapy.
1: Ibuprofen shows higher potency to reduce the pain after root canal therapy.
1: Anahil shows higher potency to reduce the pain after root canal therapy.
- combination of the Anahil and Ibuprofen would have more effective results in reducing the pain post endodontic treatment.
Read the detailed description
Patients will be selected from those who are referred to receive root canal therapy for the mandibular first molars with irreversible pulpitis.
The current research and all the procedures will be done in a private dental clinic in Qazvin, Iran by a single endodontist.
72 Patients who will meet our study demands and criteria would be qualified to enter the study and will sign the informed consent form explaining the study circumstances and its possible risks.
Patient information sheet includes dental, medical and drug history and demographic information will be obtained as well. Radiographic examination includes the amount of caries, root curvature, periapical and hard tissue situation, dental pulp vitality tests including Electrical Pulp Test(EPT) and thermal tests (heat and cold) and periapical tests consisting of percussion and palpation would be recorded. The patients would be divided randomly in Ibuprofen and Anahil groups, these drugs would be put in the same shape and appearance by a pharmacist and named as A and B respectively. Anahil capsules containing 200 mg of bromelain, Permon-Amin Health Company, Gelofen 400mg capsules, Dana-Pharma company:The pre procedure pain of the patients would be asked and recorded by Visual Analogue Scale(VAS), a 100 mm long ruler which has no numeration by means of enhancing the accuracy and minimizing the failure. Standard Infra alveolar nerve(IAN) direct block will be done by injection of 1.8ml of lidocaine 2% containing 1:100000 epinephrine with a long 32mm gauge 27 needle. The efficiency of Inferior Alveolar Nerve block injection will be examined with the numbness of inferior lip. Supplementary anesthesia (like intrapulpal or Periodontal Ligament(PDL) anesthesia) will be used if the pain is still remained after 15 minutes. After tooth isolation with rubberdam, caries removal, access cavity and tooth preparation will be done. Length determination will be performed with the help of periapical radiography and apex locator. Cleaning and shaping will be done. Normal Saline and hypochlorite 2% will be used as intracanal irrigants. The canals will then be dried and gutted laterally with gutta-percha and AH+ sealer. A cotton pellet will be placed in the access cavity. Temporary restoration will be applied after occlusal reduction and the occlusion will be checked. No intracanal medicament will be placed. In this triple blinded study, patients will be given A and B drugs (36 patients in each group, equal in gender) with medications order randomly and will be followed 6, 12, 24 and 48 hours after endodontics treatment to report the pain score with VAS and the number of supplementary dosage of Ibuprofen with the time that they have consumed.
- Conditions
- Irreversible Pulpitis
- Being tested
- Gelofen (generic name of Ibuprofen in Iran), Anahil ( generic name of Bromelain in Iran), Root Canal Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gelofen (generic name of Ibuprofen in Iran)Drug
Gelofen capsules, 400mg Ibuprofen, Dana pharma company, every 6hours
Anahil ( generic name of Bromelain in Iran)Drug
Anahil capsules,200 mg Bromelain, Permon Amin Health Company,every 6hours
Root Canal TherapyProcedure or surgery
all the participants go under RCT.
| Study group | Role | What they receive |
|---|---|---|
| Ibuprofen | Experimental | Ibuprofen(Gelofen) 400mg capsules, Dana pharma company, every 6hours Receives: Drug: Gelofen (generic name of Ibuprofen in Iran); Procedure: Root Canal Therapy |
| Anahil | Experimental | Bromelain(Anahil) 200 mg capsules, Permon Amin Health Company,every 6hours Receives: Drug: Anahil ( generic name of Bromelain in Iran); Procedure: Root Canal Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain severity
Visual Analogue Scale
Measured: 0 hour (before root canal treatment)
pain severity
Visual Analogue Scale
Measured: 6 hours after root canal treatment
pain severity
Visual Analogue Scale
Measured: 12 hours after root canal treatment
pain severity
Visual Analogue Scale
Measured: 24 hours after root canal treatment
pain severity
Visual Analogue Scale
Measured: 48 hours after root canal treatment
need of supplemental dosage of Ibuprofen
By asking the numbers of consuming capsules
Measured: 6 hours after root canal treatment
need of supplemental dosage of Ibuprofen
By asking the numbers of consuming capsules
Measured: 12 hours after root canal treatment
need of supplemental dosage of Ibuprofen
By asking the numbers of consuming capsules
Measured: 24 hours after root canal treatment
need of supplemental dosage of Ibuprofen
By asking the numbers of consuming capsules
Measured: 48 hours after root canal treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2022
- Study startMay 2022 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionDec 2022 (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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qazvin University Of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mona Esfahani, Qazvin University Of Medical Sciences
- Investigators
- Mahsa Esfehani, Ms, Study director, associate professor of oral medicine of Qazvin University Of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05349929
- Sponsor's protocol ID
- 1111
- Status last verified
- Apr 2022
- First submitted
- 5 Apr 2022
- Last updated
- 27 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 27 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Analgesic Effect of Bromelain and Ibuprofen on Pain After Root Canal Treatment(A Clinical Trial Study)
- ClinicalTrials.gov ID
- NCT05349929
- Acronym / sponsor ID
- 1111
- Conditions
- Irreversible Pulpitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Qazvin University Of Medical SciencesUniversity, hospital or other
- Study start
- May 2022 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 27 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.
Hypothesis:
0: The analgesic effect of Ibuprofen and Anahil would be the same in reducing the pain after root canal therapy.
1: Ibuprofen shows higher potency to reduce the pain after root canal therapy.
1: Anahil shows higher potency to reduce the pain after root canal therapy.
- combination of the Anahil and Ibuprofen would have more effective results in reducing the pain post endodontic treatment.
Detailed description
Patients will be selected from those who are referred to receive root canal therapy for the mandibular first molars with irreversible pulpitis.
The current research and all the procedures will be done in a private dental clinic in Qazvin, Iran by a single endodontist.
72 Patients who will meet our study demands and criteria would be qualified to enter the study and will sign the informed consent form explaining the study circumstances and its possible risks.
Patient information sheet includes dental, medical and drug history and demographic information will be obtained as well. Radiographic examination includes the amount of caries, root curvature, periapical and hard tissue situation, dental pulp vitality tests including Electrical Pulp Test(EPT) and thermal tests (heat and cold) and periapical tests consisting of percussion and palpation would be recorded. The patients would be divided randomly in Ibuprofen and Anahil groups, these drugs would be put in the same shape and appearance by a pharmacist and named as A and B respectively. Anahil capsules containing 200 mg of bromelain, Permon-Amin Health Company, Gelofen 400mg capsules, Dana-Pharma company:The pre procedure pain of the patients would be asked and recorded by Visual Analogue Scale(VAS), a 100 mm long ruler which has no numeration by means of enhancing the accuracy and minimizing the failure. Standard Infra alveolar nerve(IAN) direct block will be done by injection of 1.8ml of lidocaine 2% containing 1:100000 epinephrine with a long 32mm gauge 27 needle. The efficiency of Inferior Alveolar Nerve block injection will be examined with the numbness of inferior lip. Supplementary anesthesia (like intrapulpal or Periodontal Ligament(PDL) anesthesia) will be used if the pain is still remained after 15 minutes. After tooth isolation with rubberdam, caries removal, access cavity and tooth preparation will be done. Length determination will be performed with the help of periapical radiography and apex locator. Cleaning and shaping will be done. Normal Saline and hypochlorite 2% will be used as intracanal irrigants. The canals will then be dried and gutted laterally with gutta-percha and AH+ sealer. A cotton pellet will be placed in the access cavity. Temporary restoration will be applied after occlusal reduction and the occlusion will be checked. No intracanal medicament will be placed. In this triple blinded study, patients will be given A and B drugs (36 patients in each group, equal in gender) with medications order randomly and will be followed 6, 12, 24 and 48 hours after endodontics treatment to report the pain score with VAS and the number of supplementary dosage of Ibuprofen with the time that they have consumed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ibuprofen | Experimental | Drug: Gelofen (generic name of Ibuprofen in Iran), Procedure: Root Canal TherapyIbuprofen(Gelofen) 400mg capsules, Dana pharma company, every 6hours |
| Anahil | Experimental | Drug: Anahil ( generic name of Bromelain in Iran), Procedure: Root Canal TherapyBromelain(Anahil) 200 mg capsules, Permon Amin Health Company,every 6hours |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (14 listed)
- Patients report spontaneous pain of the first molar of mandible ranging from 50 to 100 mm on a VAS (0-100 mm)
- The dental pulp's condition is irreversible pulpitis and the tooth is reparable and need the root canal therapy
- No evidences of any lesions and lucency, PDL widening, loss of lamina dura in radiographic examination
- Patients aged 20 to 50 years from both genders
- Patients are not pregnant or breast-feeding
Key exclusion criteria (5 listed)
- Patients who leave the study because of any reasons
- Special anatomy of teeth (extra canals, severe root curvature, calcifications, open apex, C shape, fractures,..)
- Patients who are not able to tolerate the single-session treatment (time, tooth's situation,..)
- If the aspiration through IAN block injection is positive
- If the diagnosis of pulp status has changed to partial necrosis during access cavity preparation
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 |
|---|---|---|
| Gelofen (generic name of Ibuprofen in Iran)Gelofen capsules, 400mg Ibuprofen, Dana pharma company, every 6hours | Drug | Ibuprofen |
| Anahil ( generic name of Bromelain in Iran)Anahil capsules,200 mg Bromelain, Permon Amin Health Company,every 6hours | Drug | Anahil |
| Root Canal Therapyall the participants go under RCT. | Procedure or surgery | Anahil, Ibuprofen |
Primary outcome
pain severity
Time frame: 0 hour (before root canal treatment)
Visual Analogue Scale
pain severity
Time frame: 6 hours after root canal treatment
Visual Analogue Scale
pain severity
Time frame: 12 hours after root canal treatment
Visual Analogue Scale
pain severity
Time frame: 24 hours after root canal treatment
Visual Analogue Scale
pain severity
Time frame: 48 hours after root canal treatment
Visual Analogue Scale
need of supplemental dosage of Ibuprofen
Time frame: 6 hours after root canal treatment
By asking the numbers of consuming capsules
need of supplemental dosage of Ibuprofen
Time frame: 12 hours after root canal treatment
By asking the numbers of consuming capsules
need of supplemental dosage of Ibuprofen
Time frame: 24 hours after root canal treatment
By asking the numbers of consuming capsules
need of supplemental dosage of Ibuprofen
Time frame: 48 hours after root canal treatment
By asking the numbers of consuming capsules
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 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.
Mahsa Esfehani, Ms study director
associate professor of oral medicine of Qazvin University Of Medical Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Gelofen (generic name of Ibuprofen in Iran), Anahil ( generic name of Bromelain in Iran) and Root Canal Therapy in people with Irreversible Pulpitis, run by Qazvin University Of Medical Sciences.
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 14 inclusion and 5 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 27 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Mona Esfahani, Student (+989120407509, monaes2424@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain severity (time frame: 0 hour (before root canal treatment)). The study lists 9 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 27 Apr 2022.