Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT07265102
Status:
COMPLETED
Last Update Posted:
2025-12-22
First Post:
2025-11-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of a Mouthwash Containing Chlorhexidine and Chlorine Dioxide on Halitosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006209', 'term': 'Halitosis'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050558', 'term': 'Cysteine Dioxygenase'}, {'id': 'D009067', 'term': 'Mouthwashes'}], 'ancestors': [{'id': 'D049308', 'term': 'Dioxygenases'}, {'id': 'D010105', 'term': 'Oxygenases'}, {'id': 'D010088', 'term': 'Oxidoreductases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D003358', 'term': 'Cosmetics'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Both mouthwashes were packaged in identical opaque bottles labeled only with numerical codes (1 or 2) by an independent technician who was not involved in data collection or analysis. The two formulations were identical in appearance, color, odor, and taste to maintain blinding. The allocation code was kept confidential and sealed in an envelope until all data had been collected and statistical analyses were completed.\n\nParticipants, clinicians, and outcome assessors were blinded to group allocation throughout the trial. Unblinding occurred only after all data analyses were completed.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2024-03-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2025-11-24', 'studyFirstSubmitQcDate': '2025-11-24', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-12-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Hydrogen sulfide (H₂S) concentration in breath', 'timeFrame': 'baseline, immediate post-rinse, 2 weeks', 'description': 'The concentration of hydrogen sulfide (H₂S) in oral breath was measured using the OralChroma™ device. The difference between baseline, immediately after rinsing, and 2 weeks was used to assess the efficacy of the mouthwash in reducing volatile sulfur compounds.'}, {'measure': 'Change in Methyl mercaptan (CH₃SH) concentration in breath', 'timeFrame': 'Baseline, immediate post-rinse, 2 weeks', 'description': 'The concentration of methyl mercaptan (CH₃SH) in oral breath was measured using the OralChroma™ device. The difference between baseline, immediately after rinsing, and 2 weeks was used to evaluate the short-term and sustained effects of the mouthwash on halitosis.'}], 'secondaryOutcomes': [{'measure': 'Change of plaque index', 'timeFrame': 'At baseline and 2 weeks of mouthwash use', 'description': 'The Plaque Index (PI) was recorded at four surfaces per tooth (mesiobuccal, buccal, distobuccal, and lingual) to assess plaque accumulation. Each surface was scored on a scale from 0 to 3, where 0 indicates no plaque and 3 indicates abundant plaque accumulation. The mean PI score per participant was calculated at each visit. A lower score indicates less plaque accumulation and improved oral hygiene.'}, {'measure': 'Change in Gingival Index (GI)', 'timeFrame': 'At baseline and 2 weeks of mouthwash use', 'description': 'The Gingival Index (GI) was evaluated at four surfaces per tooth (mesiobuccal, buccal, distobuccal, and lingual) to assess the degree of gingival inflammation. Each surface was scored on a scale from 0 to 3, where 0 indicates normal gingiva and 3 indicates severe inflammation with marked redness, edema, and a tendency to spontaneous bleeding. The mean GI score per participant was calculated. A lower score reflects healthier gingival conditions.'}, {'measure': 'Change in Bleeding on Probing (BOP)', 'timeFrame': 'At baseline and 2 weeks of mouthwash use', 'description': 'The percentage of sites showing bleeding upon gentle probing was recorded as an indicator of gingival inflammation and bleeding tendency. The presence of bleeding was recorded at each examined site following gentle periodontal probing. BOP was expressed as the percentage of bleeding sites, calculated as the number of sites showing bleeding divided by the total number of sites examined ×100%. Higher percentages indicate greater gingival inflammation.'}, {'measure': 'Change in Tongue Coating Index', 'timeFrame': 'At baseline and 2 weeks of mouthwash use', 'description': "The tongue dorsum was visually divided into six areas (three anterior and three posterior) according to Winkel's Tongue Coating Index (WTCI). Each area was scored from 0 (no coating), 1 (mild coating), and 2 (thick coating), and the total score (0-12) was calculated as the Tongue Coating Index."}, {'measure': 'Change in salivary bacterial load (qPCR quantification)', 'timeFrame': 'At baseline and 2 weeks of mouthwash use', 'description': 'Salivary bacterial counts of Porphyromonas gingivalis, Fusobacterium nucleatum, Prevotella intermedia, Eikenella corrodens, and Aggregatibacter actinomycetemcomitans were quantified using real-time PCR (qPCR). Changes in bacterial load (log CFU/mL) between baseline and 2 weeks were compared to assess the antibacterial effect of the mouthwash.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['halitosis', 'chlorhexidine', 'chlorine dioxide', 'mouthwash', 'volatile sulfur compounds', 'tongue coating'], 'conditions': ['Halitosis']}, 'referencesModule': {'references': [{'pmid': '30386642', 'type': 'BACKGROUND', 'citation': 'Pham TAV, Nguyen NTX. Efficacy of chlorine dioxide mouthwash in reducing oral malodor: A 2-week randomized, double-blind, crossover study. Clin Exp Dent Res. 2018 Oct 23;4(5):206-215. doi: 10.1002/cre2.131. eCollection 2018 Oct.'}, {'pmid': '20152022', 'type': 'BACKGROUND', 'citation': 'Shinada K, Ueno M, Konishi C, Takehara S, Yokoyama S, Zaitsu T, Ohnuki M, Wright FA, Kawaguchi Y. Effects of a mouthwash with chlorine dioxide on oral malodor and salivary bacteria: a randomized placebo-controlled 7-day trial. Trials. 2010 Feb 12;11:14. doi: 10.1186/1745-6215-11-14.'}]}, 'descriptionModule': {'briefSummary': "Halitosis significantly impacts the quality of a patient's life. This randomized, double-blind crossover trial evaluates a mouthwash containing chlorhexidine (0.01%) and chlorine dioxide (0.05%) compared with placebo. Forty participants rinsed twice daily for 2 weeks, followed by a 2-week washout and crossover. The primary outcomes were volatile sulfur compounds (H₂S, CH₃SH), measured by OralChroma. Secondary outcomes included plaque index, gingival index, bleeding on probing, tongue coating, and salivary bacterial counts (Aa, Pg, Fn, Pi, and Ec)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥20 natural teeth\n* H₂S \\>1.5 ng/10ml or CH₃SH \\>0.5 ng/10ml\n* Signed informed consent\n\nExclusion Criteria:\n\n* Systemic disease\n* Smoking\n* Pregnancy or lactation\n* Periodontal pockets ≥4 mm\n* Recent antibiotic use (\\<1 month)\n* Orthodontic appliances or dentures\n* Allergy to CHX or C'}, 'identificationModule': {'nctId': 'NCT07265102', 'acronym': 'CHX+CDO', 'briefTitle': 'Effect of a Mouthwash Containing Chlorhexidine and Chlorine Dioxide on Halitosis', 'organization': {'class': 'OTHER', 'fullName': 'Can Tho University of Medicine and Pharmacy'}, 'officialTitle': 'A Randomized Double-Blind Crossover Clinical Trial Evaluating the Efficacy of a Mouthwash Containing Chlorhexidine and Chlorine Dioxide in Patients With Oral Malodor', 'orgStudyIdInfo': {'id': 'CHXCDO-Halitosis-2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CHX-CDO Mouthwash', 'description': 'Participants rinsed with a test mouthwash containing 0.01% chlorhexidine and 0.05% chlorine dioxide. Each participant used 15 mL of the solution twice daily (morning and evening) for 30 seconds over a period of 2 weeks. The mouthwash bottles were identical in appearance to maintain blinding.', 'interventionNames': ['Other: CHX 0.01% + CDO 0.05% mouthwash']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Mouthwash', 'description': 'Participants rinsed with a placebo mouthwash containing the same excipients, color, and flavoring agents but without chlorhexidine or chlorine dioxide. Each participant used 15 mL of the placebo solution twice daily for 30 seconds over 2 weeks.', 'interventionNames': ['Other: Placebo mouthwash']}], 'interventions': [{'name': 'CHX 0.01% + CDO 0.05% mouthwash', 'type': 'OTHER', 'otherNames': ['CHX+ CDO mouthwash'], 'description': 'Mouthwash formulation containing chlorhexidine 0.01% and chlorine dioxide 0.05%, prepared by the Department of Pharmacy, University of Medicine and Pharmacy at Ho Chi Minh City.', 'armGroupLabels': ['CHX-CDO Mouthwash']}, {'name': 'Placebo mouthwash', 'type': 'OTHER', 'otherNames': ['Control mouthwash'], 'description': 'Identical placebo formulation matched in flavor, color, and excipients but without active ingredients (CHX or CDO).', 'armGroupLabels': ['Placebo Mouthwash']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70000', 'city': 'Ho Chi Minh City', 'country': 'Vietnam', 'facility': 'Odonto-Stomatology Hospital of Ho Chi Minh City', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}], 'overallOfficials': [{'name': 'Thuy A.V. Pham, Assoc.Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Can Tho University of Medicine and Pharmacy'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'Within 6 months after publication, available for 3 years', 'ipdSharing': 'YES', 'description': 'De-identified data, study protocol, and statistical code will be available upon reasonable request', 'accessCriteria': 'Researchers with IRB-approved proposals may request access via corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Can Tho University of Medicine and Pharmacy', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Medicine and Pharmacy at Ho Chi Minh City', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}