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| Name | Class |
|---|---|
| NMSI DENTMASTER | OTHER |
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Dental pain, a common issue in stomatology, requires a multifaceted treatment approach. This study explores the efficacy of combining Ibuprofen with curcumin and liquorice root supplements for managing postoperative dental pain. Curcumin, known for its antioxidant and anti-inflammatory properties, along with liquorice root, may enhance pain relief beyond conventional NSAIDs like Ibuprofen. This randomized, double-blind, placebo-controlled trial aims to evaluate the safety and effectiveness of this combination therapy in adults undergoing the removal of impacted third molars. Participants, aged 18-85, were divided into groups receiving different doses of Ibuprofen and curcumin with liquorice root, compared to a control group receiving Ibuprofen and placebo. The primary outcome is the sum of pain intensity differences over 8 hours, with secondary outcomes including total pain relief and the occurrence of any adverse events. The anticipated sample size, considering a 20% dropout rate, is 264 participants, ensuring the study is powered to detect significant differences in pain management efficacy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group ibuprofen 400 and Curcumin | Experimental |
| |
| Intervention Group ibuprofen 200 and Curcumin | Experimental |
| |
| Intervention Group ibuprofen 400 and placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ibuprofen 400 mg in combination with Curcumin covered with liquorice root 100 mg | Dietary Supplement | The combination of ibuprofen 400 mg and Curcumin covered with liquorice root 100 mg in patients after 2-4 molars procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Sum of pain intensity differences (SPID), SPID on the visual analog score VAS (points) | 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Total pain relief (TOTPAR) % | 8 hours | |
| Time to pain half pain gone (in minutes) | 8 hours | |
| Duration of pain half gone (in minutes) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nmsi Dentmaster | Novosibirsk | Novosibirsk Oblast | 630090 | Russia |
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| ibuprofen 200 mg in combination with Curcumin covered with liquorice root 100 mg | Dietary Supplement | The combination of ibuprofen 200 mg and Curcumin covered with liquorice root 100 mg in patients after 2-4 molars procedure |
|
| The combination of ibuprofen 400 mg and placebo in patients after 2-4 molars procedure | Other | The combination of ibuprofen 400 mg and placebo 100 mg in patients after 2-4 molars procedure |
|
| 8 hours |
| Any adverse events (facial swelling, nausea, vomiting, headache) (%) | 8 hours |
| ID | Term |
|---|---|
| D014098 | Toothache |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D005157 | Facial Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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