Ignite Creation Date:
2025-12-26 @ 1:17 PM
Ignite Modification Date:
2025-12-26 @ 1:17 PM
Study NCT ID:
NCT06269406
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-08
First Post:
2024-02-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Combination of Ibuprofen With Curcumin Covered With Liquorice Root Supplementation in the Management of Postoperative Dental Pain in Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014098', 'term': 'Toothache'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D005157', 'term': 'Facial Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007052', 'term': 'Ibuprofen'}], 'ancestors': [{'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 264}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-09-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-06', 'studyFirstSubmitDate': '2024-02-12', 'studyFirstSubmitQcDate': '2024-02-20', 'lastUpdatePostDateStruct': {'date': '2025-06-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sum of pain intensity differences (SPID), SPID on the visual analog score VAS (points)', 'timeFrame': '8 hours'}], 'secondaryOutcomes': [{'measure': 'Total pain relief (TOTPAR) %', 'timeFrame': '8 hours'}, {'measure': 'Time to pain half pain gone (in minutes)', 'timeFrame': '8 hours'}, {'measure': 'Duration of pain half gone (in minutes)', 'timeFrame': '8 hours'}, {'measure': 'Any adverse events (facial swelling, nausea, vomiting, headache) (%)', 'timeFrame': '8 hours'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postoperative Dental Pain', 'Curcumin and Licorice Root', 'Ibuprofen', 'Anti-inflammatory Properties', 'molars'], 'conditions': ['Dental Pain']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Removal of 2 to 4 impacted third molars\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Ibuprofen contraindications.\n* Allergy to any of the intervention components.'}, 'identificationModule': {'nctId': 'NCT06269406', 'acronym': 'ICLID', 'briefTitle': 'A Combination of Ibuprofen With Curcumin Covered With Liquorice Root Supplementation in the Management of Postoperative Dental Pain in Adults', 'organization': {'class': 'OTHER', 'fullName': 'S.LAB (SOLOWAYS)'}, 'officialTitle': 'A Combination of Ibuprofen With Curcumin Covered With Liquorice Root Supplementation in the Management of Postoperative Dental Pain in Adults, Randomized, Double- Blind, Parallel-Group, Placebo-Controlled Study', 'orgStudyIdInfo': {'id': 'SW008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention Group ibuprofen 400 and Curcumin', 'interventionNames': ['Dietary Supplement: ibuprofen 400 mg in combination with Curcumin covered with liquorice root 100 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Group ibuprofen 200 and Curcumin', 'interventionNames': ['Dietary Supplement: ibuprofen 200 mg in combination with Curcumin covered with liquorice root 100 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Intervention Group ibuprofen 400 and placebo', 'interventionNames': ['Other: The combination of ibuprofen 400 mg and placebo in patients after 2-4 molars procedure']}], 'interventions': [{'name': 'ibuprofen 400 mg in combination with Curcumin covered with liquorice root 100 mg', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The combination of ibuprofen 400 mg and Curcumin covered with liquorice root 100 mg in patients after 2-4 molars procedure', 'armGroupLabels': ['Intervention Group ibuprofen 400 and Curcumin']}, {'name': 'ibuprofen 200 mg in combination with Curcumin covered with liquorice root 100 mg', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The combination of ibuprofen 200 mg and Curcumin covered with liquorice root 100 mg in patients after 2-4 molars procedure', 'armGroupLabels': ['Intervention Group ibuprofen 200 and Curcumin']}, {'name': 'The combination of ibuprofen 400 mg and placebo in patients after 2-4 molars procedure', 'type': 'OTHER', 'description': 'The combination of ibuprofen 400 mg and placebo 100 mg in patients after 2-4 molars procedure', 'armGroupLabels': ['Intervention Group ibuprofen 400 and placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '630090', 'city': 'Novosibirsk', 'state': 'Novosibirsk Oblast', 'country': 'Russia', 'contacts': [{'name': 'Gatilova A Tatyana, MD', 'role': 'CONTACT', 'phone': '9529399919', 'phoneExt': '+7'}], 'facility': 'Nmsi Dentmaster', 'geoPoint': {'lat': 55.02259, 'lon': 82.93175}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'S.LAB (SOLOWAYS)', 'class': 'OTHER'}, 'collaborators': [{'name': 'NMSI DENTMASTER', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}