Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 7:41 PM
Study NCT ID:
NCT07466992
Status:
COMPLETED
Last Update Posted:
2026-03-12
First Post:
2026-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Chlorhexidine and Hypochlorous Acid Mouthwash After Impacted Third Molar Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D006997', 'term': 'Hypochlorous Acid'}], 'ancestors': [{'id': 'D000148', 'term': 'Acids, Noncarboxylic'}, {'id': 'D000143', 'term': 'Acids'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D017382', 'term': 'Reactive Oxygen Species'}, {'id': 'D005609', 'term': 'Free Radicals'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-08', 'studyFirstSubmitDate': '2026-03-08', 'studyFirstSubmitQcDate': '2026-03-08', 'lastUpdatePostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Analog Scale (VAS)', 'timeFrame': '3, 6, 12 and 24 hours and the 2nd, 3rd, 4th, 5th, 6th and 7th days', 'description': "n the pain assessment, the patients were given a VAS form at 3, 6, 12 and 24 hours and on the 2nd, 3rd, 4th, 5th, 6th and 7th days and the pain felt by the patient was marked on this scale. This form consists of numbers between 0 and 10. 0 represents 'no pain at all' and 10 represents 'worst possible pain'."}, {'measure': 'Trismus', 'timeFrame': 'preop, 2th and 7th days', 'description': 'In all patients participating in the study, the maximum interincisal distance for trismus was measured and recorded by the same physician before the operation and on the 2nd and 7th days after the operation.'}, {'measure': 'Edema', 'timeFrame': 'preop, 2th and 7th days', 'description': 'For edema, some anatomical points on the face were taken as reference points and the distance between these points was measured with a tape measure and recorded. The angulus point was determined as the center point and the distances between angulus-tragus, angulus-lateral corner of the eye, angulus-nasal base, angulus-labial commissure and angulus-pogonion point were measured.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['impacted third molar', 'hypochlorous acid', 'chlorhexidine gluconate'], 'conditions': ['Impacted Mandibular Third Molar']}, 'descriptionModule': {'briefSummary': "Impacted mandibular third molar extraction is one of the most common procedures in oral and maxillofacial surgery and is frequently associated with postoperative complications such as pain, edema, and trismus, which may negatively affect patients' quality of life. Various pharmacological and topical agents have been used to reduce these postoperative complications. Chlorhexidine gluconate mouthwash is widely considered the gold standard antiseptic agent due to its broad antimicrobial activity; however, its use may be associated with adverse effects such as tooth staining and taste alteration. Hypochlorous acid is an alternative antiseptic agent with antimicrobial and anti-inflammatory properties and good tissue compatibility.\n\nThe aim of this randomized clinical study was to compare the effectiveness of hypochlorous acid mouthwash and chlorhexidine gluconate mouthwash in reducing postoperative complications following impacted mandibular third molar surgery. A total of 43 healthy patients with bilateral impacted mandibular third molars were included in the study. Postoperative outcomes including pain (VAS), edema, trismus, and wound healing were evaluated at specific follow-up intervals. The results were analyzed to determine whether hypochlorous acid could be considered a potential alternative to chlorhexidine in postoperative oral care."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 40 years\n* Presence of bilateral impacted mandibular third molars with similar surgical difficulty\n* Good general health with no systemic disease\n* Ability to comply with postoperative instructions and follow-up visits\n\nExclusion Criteria:\n\n* Presence of systemic disease\n* Pregnancy or breastfeeding\n* Active infection at the surgical site\n* History of allergy to study medications\n* Use of antibiotics or anti-inflammatory drugs within two weeks before surgery\n* Temporomandibular joint disorders causing limited mouth opening'}, 'identificationModule': {'nctId': 'NCT07466992', 'briefTitle': 'Comparison of Chlorhexidine and Hypochlorous Acid Mouthwash After Impacted Third Molar Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Yuzuncu Yil University'}, 'officialTitle': 'Postoperative Effects of Hypochlorous Acid Versus Chlorhexidine Mouthwash Following Impacted Third Molar Extraction: A Randomized Split-Mouth Study', 'orgStudyIdInfo': {'id': 'YYU-20/20.09.2021'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'chlorhexidine gluconate', 'description': 'Patients used chlorhexidine gluconate mouthwash starting 24 hours after surgery, three times daily.', 'interventionNames': ['Drug: Hypochlorous Acid', 'Drug: Chlorhexidine Gluconate Mouthwash']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hypochlorous Acid Mouthwash', 'description': 'Patients used hypochlorous acid mouthwash starting 24 hours after surgery, three times daily.', 'interventionNames': ['Drug: Hypochlorous Acid', 'Drug: Chlorhexidine Gluconate Mouthwash']}], 'interventions': [{'name': 'Hypochlorous Acid', 'type': 'DRUG', 'description': 'Hypochlorous acid mouthwash is an antimicrobial oral rinse with broad-spectrum activity against bacteria, viruses, and fungi. It is used as a postoperative antiseptic agent to reduce microbial load, inflammation, and the risk of infection following oral surgical procedures.', 'armGroupLabels': ['Hypochlorous Acid Mouthwash', 'chlorhexidine gluconate']}, {'name': 'Chlorhexidine Gluconate Mouthwash', 'type': 'DRUG', 'description': 'Patients used chlorhexidine gluconate mouthwash starting 24 hours after surgery, three times daily.', 'armGroupLabels': ['Hypochlorous Acid Mouthwash', 'chlorhexidine gluconate']}]}, 'contactsLocationsModule': {'locations': [{'zip': '65580', 'city': 'Van', 'country': 'Turkey (Türkiye)', 'facility': 'Van Yüzüncü Yıl Üniversitesi Diş Hekimliği Fakültesi', 'geoPoint': {'lat': 38.49457, 'lon': 43.38323}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Yuzuncu Yil University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Serap Keskin Tunc', 'investigatorAffiliation': 'Yuzuncu Yil University'}}}}