Ignite Creation Date:
2025-12-25 @ 2:58 AM
Ignite Modification Date:
2026-01-01 @ 4:02 AM
Study NCT ID:
NCT07106333
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-06
First Post:
2025-07-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Ozone Therapy for Management of Post-Extraction Localized Alveolar Osteitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004368', 'term': 'Dry Socket'}], 'ancestors': [{'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007507', 'term': 'Therapeutic Irrigation'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D006875', 'term': 'Hydrotherapy'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'intervention after wisdom tooth extraction either with saline or with topical ozone'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2026-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-29', 'studyFirstSubmitDate': '2025-07-15', 'studyFirstSubmitQcDate': '2025-07-29', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Reduction', 'timeFrame': 'Pain intensity will be recorded at: Day 2 Day 3 Day 7 Day 10 Day 14', 'description': 'Patient-reported pain scale, categorized as:\n\nSevere\n\nModerate\n\nMild\n\nNo pain'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alveolar Osteitis']}, 'descriptionModule': {'briefSummary': 'This clinical study investigates the effectiveness of ozone therapy in comparison to conventional treatment for alveolar osteitis (AO), a common painful complication following tooth extraction. Forty patients diagnosed with dry socket will be randomly divided into two groups. Group A will receive traditional treatment with normal saline irrigation and analgesics, while Group B will be treated using ozonated water, ozonated gel, and analgesics. Both groups will be monitored over a two-week period to evaluate pain levels, healing progression, and other clinical indicators. The study aims to assess the palliative and regenerative benefits of ozone therapy in managing AO, potentially offering an alternative to conventional symptomatic treatments.', 'detailedDescription': 'Alveolar osteitis (AO), commonly referred to as "dry socket," is a frequent postoperative complication following tooth extraction. It typically presents 1-3 days post-extraction with severe pain due to premature loss or breakdown of the blood clot within the extraction socket. While the exact pathogenesis remains controversial, enhanced fibrinolytic activity, bone trauma, and bacterial contamination are considered primary contributing factors. The incidence is notably higher in mandibular third molars.\n\nTraditional management approaches-such as saline irrigation, antibiotics, and eugenol-based dressings-are often palliative and do not directly target the underlying cause. Ozone therapy, with its antimicrobial, analgesic, and wound-healing properties, has recently emerged as a potential alternative. Ozone, when applied in water or gel forms, is believed to promote clot stability, reduce pain, and enhance soft tissue regeneration.\n\nAim of the Study:\n\nTo assess and compare the palliative (pain-relieving) and regenerative (healing-promoting) effects of ozone therapy versus conventional treatment in patients suffering from alveolar osteitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge: 18-60 years.\n\nPatients undergoing simple (non-surgical) extractions.\n\nMedically healthy individuals.\n\nExclusion Criteria:\n\nPatients already treated for AO.\n\nPresence of systemic diseases affecting healing.\n\nSevere infections or facial swelling.\n\nIncomplete follow-up.\n\nContraindications to ozone therapy: G6PD deficiency, hyperthyroidism, malignant hypertension, recent myocardial infarction.'}, 'identificationModule': {'nctId': 'NCT07106333', 'briefTitle': 'Assessment of Ozone Therapy for Management of Post-Extraction Localized Alveolar Osteitis', 'organization': {'class': 'OTHER', 'fullName': 'Menoufia University'}, 'officialTitle': 'Management of Post-Extraction Localized Alveolar Osteitis', 'orgStudyIdInfo': {'id': 'ADMNF-00225'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Group A - Conventional Treatment (Control Group):', 'description': 'Socket debridement and irrigation with normal saline.\n\nPain management using Diclofenac potassium (50 mg TID).\n\nFollow-up at day 2, 3, 7, 10, and 14.\n\nHome care: saline mouth rinse.', 'interventionNames': ['Other: Irrigation with saline']}, {'type': 'OTHER', 'label': 'Group B-Ozone Therapy Group', 'description': 'Socket debridement and irrigation with ozonated water.\n\nApplication of ozonated gel into the socket using syringe with fine-tip applicator.\n\nPain management using Diclofenac potassium (50 mg TID).\n\nPatients instructed to use ozonated water and gel at home daily.\n\nFollow-up at day 2, 3, 7, 10, and 14.', 'interventionNames': ['Other: Topical Ozone Therapy']}], 'interventions': [{'name': 'Topical Ozone Therapy', 'type': 'OTHER', 'description': 'The intervention involves local application of ozone in two forms:\n\nOzonated Water - used for irrigation of the extraction socket.\n\nOzonated Gel - applied topically inside the socket to promote healing and reduce pain.\n\nBoth are used after socket debridement and bleeding provocation, followed by standard analgesic administration (Diclofenac potassium).', 'armGroupLabels': ['Group B-Ozone Therapy Group']}, {'name': 'Irrigation with saline', 'type': 'OTHER', 'description': 'The intervention involves irrigation with saline', 'armGroupLabels': ['Group A - Conventional Treatment (Control Group):']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mohammed A. El-Sawy, PhD', 'role': 'CONTACT', 'email': 'Dr_sawy@windowslive.com', 'phone': '00201061314522'}, {'name': 'Mohammed T. Khater, PhD', 'role': 'CONTACT', 'email': 'MohamedKhaterdentalsmile1234@gmail.com', 'phone': '00201003854552'}], 'overallOfficials': [{'name': 'Mohammed El-Sawy, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Menoufia Universityt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Up on request from the corresponding author'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Menoufia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor and principle investigator', 'investigatorFullName': 'Mohammed El-Sawy', 'investigatorAffiliation': 'Menoufia University'}}}}