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| Name | Class |
|---|---|
| Egyptian Russian University | NETWORK |
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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.
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 ibuprofen or dexamethasone 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 ibuprofen or dexamethasone or placebo on anesthetic success and post-operative pain after endodontic treatment."
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| NSAIDs Group | Active Comparator | Patients will receive Diclofenac Potassium (50 mg) as a single oral dose 1 hour before treatment. |
|
| Steroid Group | Active Comparator | Patients will receive a single oral dose of a steroid drug (20 mg prednisolone) 1 hour before treatment. |
|
| Placebo group | Placebo Comparator | Patients will receive a single oral dose of placebo (opaque white capsule filled with starch) 1 hour before treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trypsin, Bromelain and Rutoside | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Each patient will deliver his/her pain diary one week after root canal treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maha Nasr | Egyptian Russian University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Oral and Dental Medicine, Egyptian Russian University | Cairo | Cairo Governorate | 11829 | Egypt | ||
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| ID | Term |
|---|---|
| D014357 | Trypsin |
| D001963 | Bromelains |
| D012431 | Rutin |
| D004008 | Diclofenac |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D012697 | Serine Endopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
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| Diclofenac Potassium 50mg Tab | Drug | 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 Tablet | Drug | Steroids are potent anti inflammatory drugs, patients are going to receive one tablet of 20 mg solupred one hour before treatment |
|
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| Placebo | Other | An opaque white capsule filled with starch |
|
| Faculty of Dentistry, Cairo University |
| Cairo |
| 4450113 |
| Egypt |
| D004798 |
| Enzymes |
| D045762 | Enzymes and Coenzymes |
| D057057 | Serine Proteases |
| D003546 | Cysteine Endopeptidases |
| D057056 | Cysteine Proteases |
| D044948 | Flavonols |
| D005419 | Flavonoids |
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |