Ignite Creation Date:
2025-12-25 @ 1:33 AM
Ignite Modification Date:
2026-03-03 @ 9:15 PM
Study NCT ID:
NCT03741894
Status:
UNKNOWN
Last Update Posted:
2018-11-15
First Post:
2018-10-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Examination of the Prevention and Treatment Modalities of Alveolitis in Relation With Impacted Teeth Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004368', 'term': 'Dry Socket'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C010473', 'term': 'iodoform'}, {'id': 'D002710', 'term': 'Chlorhexidine'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2021-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-11-12', 'studyFirstSubmitDate': '2018-10-30', 'studyFirstSubmitQcDate': '2018-11-12', 'lastUpdatePostDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in minor postoperative complications (trismus)', 'timeFrame': 'day of surgery, 3rd, 7th postoperative days', 'description': 'Measuring postoperative trismus (maximal mouth opening - inter-incisal distance in millimeters).'}, {'measure': 'Change in minor postoperative complications (oedema)', 'timeFrame': 'day of surgery, 3rd, 7th postoperative days', 'description': 'measuring postoperative oedema (flexible ruler- lateral canthus-mandibular angle distance in millimeters and tragus-labial commissure distance in millimeters).'}, {'measure': 'Change in minor postoperative complications (pain)', 'timeFrame': '1st, 2nd, 3rd, 4th, 5th, 6th and 7th postoperative days', 'description': 'Measuring level of pain in Visual Analog Scale (minimum score is 0 which represents no pain, maximum score is 10 which shows the worst pain) postoperatively'}, {'measure': 'Change in necessity of postoperatively taken analgesics', 'timeFrame': '1st, 2nd, 3rd, 4th, 5th, 6th and 7th postoperative days', 'description': 'Registering dose of active agent of taken analgesics in milligrams .'}, {'measure': 'Change in necessity of postoperatively taken analgesics', 'timeFrame': '1st, 2nd, 3rd, 4th, 5th, 6th and 7th postoperative days', 'description': 'Registering number of daily repeats of taken analgesics.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['alveolitis', 'iodoform', 'chlorhexidine', 'minor complications'], 'conditions': ['Alveolitis of Jaw', 'Alveoli, Teeth; Inflammation', 'Dry Socket', 'Impacted Third Molar Tooth']}, 'descriptionModule': {'briefSummary': 'In the everyday clinical practice the incidence of minor complications is approximately 15-20% of the total number of third molar removals. Alveolitis (dry socket syndrome) may arise in 30-40% of the surgical tooth removals. Several preventive approaches are known, such as the use of iodoform gauze, zink-oxide eugenol paste, platelet rich fibrin (PRF), different medicine containing pastes, like antibiotics containing, non-steroid pain killer containing, steroid containing, or the application of chlorhexidine gel and solutions. In the case of a manifest alveolitis these methods can be used as well. The aims of this research are: i) to identify the important pathogens which play role in the development of alveolitis (microbiological methods), ii) to analyze the in vitro effectivity of the different antiseptic materials in case of infections (inhibitory zones) iii) to compare the effectivity of different alveolitis preventive methods in a prospective clinical study, iv) to compare the different treatment options in alveolitis in a prospective clinical study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pell-Gregory II/B impaction\n* mesioangular impactions\n* tooth sectioning is not necessary for removal\n* without local infection of third molar\n\nExclusion Criteria:\n\n* no general diseases or following treatments (DM, steroids, bleeding risk, chemotherapy, radiotherapy, bisphosphonates, immunosuppressive conditions)'}, 'identificationModule': {'nctId': 'NCT03741894', 'acronym': 'AITS', 'briefTitle': 'Examination of the Prevention and Treatment Modalities of Alveolitis in Relation With Impacted Teeth Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Pecs'}, 'officialTitle': 'Examination of the Prevention and Treatment Modalities of Alveolitis in Relation With Impacted Teeth Surgery', 'orgStudyIdInfo': {'id': '7065-PTE 2018.'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Primary wound closure', 'description': 'Routine primary wound closure with single interrupted sutures (Surgilon 3-0 non-absorbable) only.', 'interventionNames': ['Other: Wound closure using sutures']}, {'type': 'EXPERIMENTAL', 'label': 'Iodoform and wound closure', 'description': 'Patients get iodoform (1000 grams containing 350 grams of iodoform, 300 grams of glycerin and 350 grams of alcohol 96%) soaked gauze (steril selvedge gauze bandage 2 cm x 5 m in appropriate length) drainage during suture (Surgilon 3-0 non-absorbable) placements for a week.', 'interventionNames': ['Drug: Iodoform', 'Other: Wound closure using sutures']}, {'type': 'EXPERIMENTAL', 'label': 'Chlorhexidine and wound closure', 'description': 'Extraction sockets are filled with 1% chlorhexidine gel (Curasept ADS310, Sager Pharma, Sager Dental Kft.,Budapest, Hungary) before suture (Surgilon 3-0 non-absorbable) placements.', 'interventionNames': ['Other: Wound closure using sutures', 'Drug: Chlorhexidine']}], 'interventions': [{'name': 'Iodoform', 'type': 'DRUG', 'description': 'Patients get iodoform (1000 grams containing 350 grams of iodoform, 300 grams of glycerin and 350 grams of alcohol 96%) soaked gauze (steril selvedge gauze bandage 2 cm x 5 m in appropriate length) drainage during suture placements for a week.', 'armGroupLabels': ['Iodoform and wound closure']}, {'name': 'Wound closure using sutures', 'type': 'OTHER', 'description': 'Routine primary wound closure with single interrupted sutures (Surgilon 3-0 non-absorbable) only.', 'armGroupLabels': ['Chlorhexidine and wound closure', 'Iodoform and wound closure', 'Primary wound closure']}, {'name': 'Chlorhexidine', 'type': 'DRUG', 'description': 'Extraction sockets are filled with 1% chlorhexidine gel (Curasept ADS310, Sager Pharma, Sager Dental Kft.,Budapest, Hungary) before suture (Surgilon 3-0 non-absorbable) placements.', 'armGroupLabels': ['Chlorhexidine and wound closure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7621', 'city': 'Pécs', 'status': 'RECRUITING', 'country': 'Hungary', 'contacts': [{'name': 'Jozsef Szalma, DMD, PhD', 'role': 'CONTACT', 'email': 'drszalma@freemail.hu', 'phone': '+3672535924'}, {'name': 'Jozsef Szalma, DMD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Laszlo Vajta, DMD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Balázs Soós, DMD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Kata Janovics, DMD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Department of Oral and Maxillofacial Surgery, University of Pécs', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pecs', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DMD, Assistant Professor', 'investigatorFullName': 'Balazs Soos', 'investigatorAffiliation': 'University of Pecs'}}}}