Symptomatic Irreversible PulpitisNCT06298383
The Effect of Three Different Medications on Anesthetic Success and Postoperative Pain
A study testing Trypsin, Bromelain and Rutoside, Diclofenac Potassium 50mg Tab and Prednisolone Oral Tablet in people with Symptomatic Irreversible Pulpitis, run by Cairo University at 2 sites in Egypt.
Trial summary
Pain is a very important factor in Endodontic treatment, Both intra- and Post-operatively. In case of symptomatic Irreversible pulpitis, a build up of inflammatory mediators makes it very difficult for the operator to reach the desired level of anesthesia in order to deliver a pain free treatment as well as to… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Symptomatic Irreversible Pulpitis
- What is being tested?
- Trypsin, Bromelain and Rutoside, Diclofenac Potassium 50mg Tab and Prednisolone Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 2 sitesEgypt
- Study dates
- 15 Jun 2025to 15 Mar 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with symptomatic irreversible pulpitis.
- Patients with active pain (moderate-to-severe) in mandibular molars.
- Males and females.
- Patient with the ability to understand and use pain scales.
- Patient who accepts to enroll to the study
Who cannot join
- Patients' allergies or any other contraindication to any of the used medications or mepivacaine.
- Pregnant and lactating females.
- Patients have been taking pain medication 12 hours earlier.
- Patient has more than one symptomatic mandibular tooth in the same quadrant.
- Patients with periradicular pathosis and/or radiolucency other than widened periodontal ligaments.
- Patients with contributory medical history (ASA>II).
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Faculty of Oral and Dental Medicine, Egyptian Russian University
Cairo, Cairo Governorate, 11829
Faculty of Dentistry, Cairo University
Cairo, 4450113
About this study
Official title: The Effect of Premedication With Trypsin, Bromelain and Rutoside Combination on the Success of IAN Block and Post Endodontic Pain in Patients With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial
Pain is a very important factor in Endodontic treatment, Both intra- and Post-operatively. In case of symptomatic Irreversible pulpitis, a build up of inflammatory mediators makes it very difficult for the operator to reach the desired level of anesthesia in order to deliver a pain free treatment as well as to eliminate or at least reduce post-operative pain incidence and severity. therefore, a number of pre- medications was suggested with variable success rates. Therefore this trial aims at the use of a new category of anti-inflammatory medications which would be less harmful than the standard NSAIDs or steroids.
Read the detailed description
Background and Rationale
For patients with irreversible pulpitis, achieving adequate pulpal anesthesia during endodontic therapy is a major concern, posing a considerable difficulty from a clinical point of view as an inadequately anesthetized hot tooth with severe pain will not only elevate the patients' apprehension but will also stress the practicing clinician. Inferior alveolar nerve block (IANB) technique is commonly used to achieve pulpal anesthesia in mandibular teeth. The failure rates of a single IANB block injection of local anesthetic in patients with irreversible pulpitis range between 30 and 90 %.
Several clinical studies identified inflammation as a major cause of failure of local anesthesia and an important component of the pathogenesis of hyperalgesia. The use of both steroidal and nonsteroidal anti-inflammatory drugs (NSAIDs) was investigated to improve the success rates of IANB anesthesia. Combined with the bioflavonoid rutin (Rutoside), the proteases Trypsin and Bromelain have been extensively investigated as alternatives to conventional therapies for pain and swelling associated with diverse conditions.
The aim of the trial To assess the effect of Trypsin, Bromelain and Rutoside combination versus diclofenac potassium or prednisolone or placebo on the anesthetic success of IANB and postoperative pain in patients with symptomatic irreversible pulpitis.
The null hypothesis tested is " In patients with symptomatic irreversible pulpitis in their mandibular molars, there is no difference between Trypsin, Bromelain and Rutoside combination or diclofenac potassium or prednisolone or placebo on anesthetic success and post-operative pain after endodontic treatment."
- Conditions
- Symptomatic Irreversible Pulpitis
- Being tested
- Trypsin, Bromelain and Rutoside, Diclofenac Potassium 50mg Tab, Prednisolone Oral Tablet, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trypsin, Bromelain and RutosideDrug
Also called Flamogen
Flamogen is a combination of trypsin 48 mgs, bromelain 90mg and rutoside 100 mg in one tablet that provides an anti inflammatory, anti edematous activity. each patient will receive a single dose of 2 tablets one hour before treatment.
Diclofenac Potassium 50mg TabDrug
Non-steroidal anti inflammatory drug. Cataflam is known for its potent anti inflammatory and analgesic properties. each patient will receive one tablet of Cataflam 50 mg 1 hour before treatment.
Prednisolone Oral TabletDrug
Also called solupred
Steroids are potent anti inflammatory drugs, patients are going to receive one tablet of 20 mg solupred one hour before treatment
PlaceboOther
An opaque white capsule filled with starch
| Study group | Role | What they receive |
|---|---|---|
| Trypsin, Bromelain and Rutoside (TBR) Group | Experimental | patients will receive Trypsin, Bromelain and Rutoside combination (2 tablets of flamogen a combination of Trypsin 48mg, Bromelain 90mg and Rutoside 100mg) as a single oral dose 1 hour before treatment. Receives: Drug: Trypsin, Bromelain and Rutoside |
| NSAIDs Group | Active comparator | Patients will receive Diclofenac Potassium (50 mg) as a single oral dose 1 hour before treatment. Receives: Drug: Diclofenac Potassium 50mg Tab |
| Steroid Group | Active comparator | Patients will receive a single oral dose of a steroid drug (20 mg prednisolone) 1 hour before treatment. Receives: Drug: Prednisolone Oral Tablet |
| Placebo group | Placebo comparator | Patients will receive a single oral dose of placebo (opaque white capsule filled with starch) 1 hour before treatment Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of Anesthesia
Success of Inferior alveolar Nerve block anesthesia will be measured by recording the patient's pain severity before and after anesthesia administration as well as during endodontic procedures. each patient will record his/her pain on a "Numerical Rating Scale" (NRS), the NRS is an eleven point scale anchored at both ends by zero representing no pain and 10 representing pain as bad as it could be.
Measured: Perioperative
Post-operative pain
postoperative pain as recorded by the patient after completion of treatment in on visit.
patient will receive a pain diary to record their postoperative pain incidence and severity at 6, 12, 24, 72 hours and 7 days after endodontic treatment.
Each patient will record his/her pain on a "Numerical Rating Scale" (NRS), the NRS is an eleven point scale anchored at both ends by zero representing no pain and 10 representing pain as bad as it could be.
Measured: Each patient will deliver his/her pain diary one week 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 posted7 Mar 2024
- Study start15 Jun 2025
- Primary completion15 Feb 2026
- Study completion15 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Symptomatic Irreversible PulpitisStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Collaborators
- Egyptian Russian University
- Responsible party
- Principal investigator, Maha Nasr, Cairo University
- Investigators
- Maha Nasr, Principal investigator, Egyptian Russian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06298383
- Sponsor's protocol ID
- ERU1
- Status last verified
- May 2026
- First submitted
- 19 Feb 2024
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nasr M, Hassan N. The Effect of Premedication With Trypsin, Bromelain and Rutoside Combination on Anaesthetic Success and Postoperative Pain in Patients With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial. Int Endod J. 2026 Jul 19. doi: 10.1111/iej.70231. Online ahead of print.
PubMed 42473278
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Premedication With Trypsin, Bromelain and Rutoside Combination on the Success of IAN Block and Post Endodontic Pain in Patients With Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06298383
- Acronym / sponsor ID
- ERU1
- Conditions
- Symptomatic Irreversible Pulpitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Collaborators
- Egyptian Russian University
- Study start
- 15 Jun 2025 (actual)
- Primary completion
- 15 Feb 2026 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 7 Mar 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.
Pain is a very important factor in Endodontic treatment, Both intra- and Post-operatively. In case of symptomatic Irreversible pulpitis, a build up of inflammatory mediators makes it very difficult for the operator to reach the desired level of anesthesia in order to deliver a pain free treatment as well as to eliminate or at least reduce post-operative pain incidence and severity. therefore, a number of pre- medications was suggested with variable success rates. Therefore this trial aims at the use of a new category of anti-inflammatory medications which would be less harmful than the standard NSAIDs or steroids.
Detailed description
Background and Rationale
For patients with irreversible pulpitis, achieving adequate pulpal anesthesia during endodontic therapy is a major concern, posing a considerable difficulty from a clinical point of view as an inadequately anesthetized hot tooth with severe pain will not only elevate the patients' apprehension but will also stress the practicing clinician. Inferior alveolar nerve block (IANB) technique is commonly used to achieve pulpal anesthesia in mandibular teeth. The failure rates of a single IANB block injection of local anesthetic in patients with irreversible pulpitis range between 30 and 90 %.
Several clinical studies identified inflammation as a major cause of failure of local anesthesia and an important component of the pathogenesis of hyperalgesia. The use of both steroidal and nonsteroidal anti-inflammatory drugs (NSAIDs) was investigated to improve the success rates of IANB anesthesia. Combined with the bioflavonoid rutin (Rutoside), the proteases Trypsin and Bromelain have been extensively investigated as alternatives to conventional therapies for pain and swelling associated with diverse conditions.
The aim of the trial To assess the effect of Trypsin, Bromelain and Rutoside combination versus diclofenac potassium or prednisolone or placebo on the anesthetic success of IANB and postoperative pain in patients with symptomatic irreversible pulpitis.
The null hypothesis tested is " In patients with symptomatic irreversible pulpitis in their mandibular molars, there is no difference between Trypsin, Bromelain and Rutoside combination or diclofenac potassium or prednisolone or placebo on anesthetic success and post-operative pain after endodontic treatment."
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, Bromelain and Rutoside (TBR) Group | Experimental | Drug: Trypsin, Bromelain and Rutosidepatients will receive Trypsin, Bromelain and Rutoside combination (2 tablets of flamogen a combination of Trypsin 48mg, Bromelain 90mg and Rutoside 100mg) as a single oral dose 1 hour before treatment. |
| NSAIDs Group | Active comparator | Drug: Diclofenac Potassium 50mg TabPatients will receive Diclofenac Potassium (50 mg) as a single oral dose 1 hour before treatment. |
| Steroid Group | Active comparator | Drug: Prednisolone Oral TabletPatients will receive a single oral dose of a steroid drug (20 mg prednisolone) 1 hour before treatment. |
| Placebo group | Placebo comparator | Other: PlaceboPatients will receive a single oral dose of placebo (opaque white capsule filled with starch) 1 hour before treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with symptomatic irreversible pulpitis.
- Patients with active pain (moderate-to-severe) in mandibular molars.
- Males and females.
- Patient with the ability to understand and use pain scales.
- Patient who accepts to enroll to the study
Key exclusion criteria (6 listed)
- Patients' allergies or any other contraindication to any of the used medications or mepivacaine.
- Pregnant and lactating females.
- Patients have been taking pain medication 12 hours earlier.
- Patient has more than one symptomatic mandibular tooth in the same quadrant.
- Patients with periradicular pathosis and/or radiolucency other than widened periodontal ligaments.
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 |
|---|---|---|
| Trypsin, Bromelain and RutosideAlso: FlamogenFlamogen is a combination of trypsin 48 mgs, bromelain 90mg and rutoside 100 mg in one tablet that provides an anti inflammatory, anti edematous activity. each patient will receive a single dose of 2 tablets one hour before treatment. | Drug | Trypsin, Bromelain and Rutoside (TBR) Group |
| Diclofenac Potassium 50mg TabNon-steroidal anti inflammatory drug. Cataflam is known for its potent anti inflammatory and analgesic properties. each patient will receive one tablet of Cataflam 50 mg 1 hour before treatment. | Drug | NSAIDs Group |
| Prednisolone Oral TabletAlso: solupredSteroids are potent anti inflammatory drugs, patients are going to receive one tablet of 20 mg solupred one hour before treatment | Drug | Steroid Group |
| PlaceboAn opaque white capsule filled with starch | Other | Placebo group |
Primary outcome
Success of Anesthesia
Time frame: Perioperative
Success of Inferior alveolar Nerve block anesthesia will be measured by recording the patient's pain severity before and after anesthesia administration as well as during endodontic procedures. each patient will record his/her pain on a "Numerical Rating Scale" (NRS), the NRS is an eleven point scale anchored at both ends by zero representing no pain and 10 representing pain as bad as it could be.
Post-operative pain
Time frame: Each patient will deliver his/her pain diary one week after root canal treatment
postoperative pain as recorded by the patient after completion of treatment in on visit. patient will receive a pain diary to record their postoperative pain incidence and severity at 6, 12, 24, 72 hours and 7 days after endodontic treatment. Each patient will record his/her pain on a "Numerical Rating Scale" (NRS), the NRS is an eleven point scale anchored at both ends by zero representing no pain and 10 representing pain as bad as it could be.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Derived from this study: PubMed 42473278Nasr M, Hassan N. The Effect of Premedication With Trypsin, Bromelain and Rutoside Combination on Anaesthetic Success and Postoperative Pain in Patients With Symptomatic Irreversible Pulpitis: A Randomized Controlled Trial. Int Endod J. 2026 Jul 19. doi: 10.1111/iej.70231. Online ahead of print.
- Individual participant dataSharing planned: No
Related trials for Symptomatic Irreversible Pulpitis
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Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
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Not yet recruitingPhase 3
Submucosal Cryotherapy and Anti-inflammatory Drugs for Postoperative Pain Following Root Canal Treatment in Maxillary Molars
Pulpitis
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Intraligamentary vs Inferior Alveolar Nerve Block for Pulpitis: A Randomized Clinical Trial
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Cost-Effectiveness of Upfront Supplemental Anaesthesia in Symptomatic Irreversible Pulpitis
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Effect of Menstrual Phase on the Anesthetic Efficacy
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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.
Maha Nasr principal investigator
Egyptian Russian University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trypsin, Bromelain and Rutoside, Diclofenac Potassium 50mg Tab and Prednisolone Oral Tablet in people with Symptomatic Irreversible Pulpitis, run by Cairo University at 2 sites 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 6 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: finished, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Success of Anesthesia (time frame: Perioperative). 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?
On the ClinicalTrials.gov record for NCT06298383, which also lists 1 linked publication.
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 22 Jul 2026.