Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT06193720
Status:
COMPLETED
Last Update Posted:
2024-01-05
First Post:
2023-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Impact of Arnica Montana Following the Surgical Extraction of Impacted Third Molars
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004487', 'term': 'Edema'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D014313', 'term': 'Trismus'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D013035', 'term': 'Spasm'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000712347', 'term': 'Arnicae flos extract'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-02-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-08-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-20', 'studyFirstSubmitDate': '2023-12-05', 'studyFirstSubmitQcDate': '2023-12-20', 'lastUpdatePostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain VSA', 'timeFrame': 'at 0,1,2,3,4,5,6,7 days after surgery', 'description': 'Assessment of pain on visual analogue scale (between 0 and 10, 0 being no pain at all and 10 being the worst pain)'}, {'measure': 'Amount of face Swelling', 'timeFrame': 'at 0,2,7 days after surgery', 'description': 'Assessment of swelling after the intervention using a flexible ruler to measure the distance between fixed fixed reference points marked on the face:\n\n* G: Mandibular angle\n* C: External canthus\n* T: Tragus\n* S: Sub-nasal point\n* P: Pogonion'}, {'measure': 'Trismus intensity', 'timeFrame': 'at 0,2 and 7 days after surgery', 'description': 'Assessment of limitation of mouth opening after intervention between the incisal edges of the maxillary and the mandibular central incisors using a vernier caliper'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Edema', 'Pain', 'Trismus']}, 'descriptionModule': {'briefSummary': "Aim: The aim of this study is to evaluate the action of the homeopathic plant Arnica Montana on postoperative edema, pain and trismus after surgical extraction of impacted wisdom teeth.\n\nMaterials and Methods: The study is a double-blinded clinical trial recruiting patients undergoing surgical extraction of symmetrically impacted maxillary or mandibular third molars (right and left side). Patients receive alternately and randomly the verum (Arnica Montana 12 CH) or the placebo, in the form of capsules, to be taken 1 day prior to surgery and for 7 days postoperatively. Clinical parameters are collected and include: pain score, maximum mouth opening and facial measurements to assess edema's intensity."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '16 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Symmetrically impacted bilateral third molars (mandibular or maxillary).\n* Young patients aged between 16 and 40 years old.\n* No consumption of tobacco or coffee.\n* Consent to the terms and conditions of the study.\n* Good oral hygiene.\n* ASA 1.\n\nExclusion Criteria:\n\n* Not symmetrically impacted third molars\n* Patients with health problems'}, 'identificationModule': {'nctId': 'NCT06193720', 'briefTitle': 'The Impact of Arnica Montana Following the Surgical Extraction of Impacted Third Molars', 'organization': {'class': 'OTHER', 'fullName': 'Saint-Joseph University'}, 'officialTitle': 'The Impact of Arnica Montana on Postoperative Pain, Swelling and Trismus Following the Surgical Extraction of Impacted Third Molars: A Split Mouth Randomized Clinical Double Blinded Trial', 'orgStudyIdInfo': {'id': 'XFMD126'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arnica Montana', 'description': 'Patients will take Arnica montana before and after surgery', 'interventionNames': ['Drug: Arnica montana']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Patients will take placebo pills to compare the results', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Arnica montana', 'type': 'DRUG', 'description': 'Assess the effect of arnica montana on pain, swelling ans trismus after impacted third molar surgery', 'armGroupLabels': ['Arnica Montana']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Patients will take placebo drug after surgeries', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beirut', 'country': 'Lebanon', 'facility': 'Saint Joseph University', 'geoPoint': {'lat': 33.89332, 'lon': 35.50157}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Saint-Joseph University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Christian Makary', 'investigatorAffiliation': 'Saint-Joseph University'}}}}