[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585324":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":30,"centralContacts":35,"locations":42,"responsibleParty":59,"collaborators":24,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":24,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":24,"studyType":76,"phases":77,"briefSummary":80,"conditions":81,"keywords":85,"overallStatus":45,"whyStopped":24,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},{"fullName":5,"class":6},"Al-Mustansiriyah University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Kefir Mouth Wash","ACTIVE_COMPARATOR","The experimental group will take 60 mL of kefir mouthwash (Yogourmet, France) which contains live probiotic strains and active bacterial and yeast cultures, including (Lactococcus lactis, Lactococcus cremoris, Lactococcus diacetylactis, Lactobacillus acidophilus, Saccharomyces cerevisiae, and Kluyveromyces lactis, and maltodextrin)mixed with milk with 3 percent fat (Pegah, Iran) .The milk will be heated to boiling point and then allow to cool to room temperature (25°C). After cooling, the kefir powder will be dissolved and culture for 24 hours, use 60 ml daily, split into 30 mL in the morning and 30 mL in the evening. To guarantee uniformity in the intervention, participants follow a set rinse technique.\n\nParticipants will be instructed to use the respective mouthwash (Kefir mouth wash) twice daily for 1 minute, 30 minutes after brushing their teeth, after the mouthwash application, participants will be advised not to eat or drink anything for one hour to ensure accurate results.",[13],"Combination Product: Kefir Mouth Wash",{"label":15,"type":6,"description":16,"interventionNames":17},"Chlorhexidine 0,12% Bio fresh Mouth Wash","The control group will take 30 mL of 0.12% chlorhexidine Bio fresh mouthwash (Scirto Co for Bio fresh LIC)daily, split into 15 mL in the morning and 15 mL in the evening. To guarantee uniformity in the intervention, participants follow a set rinse technique.\n\nParticipants will be instructed to use the respective mouthwash (chlorhexidine) for 28 days twice daily for 1 minute, 30 minutes after brushing their teeth, after the mouthwash application, participants will be advised not to eat or drink anything for one hour to ensure accurate results.",[18],"Drug: Chlorhexidine 0,12%Biofresh Mouthwash",[20,25],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":24},"COMBINATION_PRODUCT","A kefir-based mouthwash was developed with active bacterial and yeast cultures, including Lactococcus lactis, Lactococcus cremoris, Lactococcus diacetylactis, Lactobacillus acidophilus, Saccharomyces cerevisiae, and Kluyveromyces lactis, along with maltodextrin and 3% fat milk. The recipe also calls for milk from Pegah, Iran. The milk is initially heated to boiling point and then allowed to cool to room temperature (25°C). After cooling, the kefir powder will be dissolved in the cooled milk and mixed well. For every 1 liter of milk, 3g of kefir starter yogurt (Yogourmet, France) will be added. The inoculated milk will then be transferred into a clean, airtight container, and the lid will be sealed. The container will be left at room temperature for approximately 24 hours until the kefir curd forms. After 24 hours, the kefir will be refrigerated for about 8 hours to halt the fermentation process.",[9],null,{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":24},"DRUG","Chlorhexidine 0,12%Biofresh Mouthwash","Chlorhexidine mouthwash is used as a standard treatment (Scitra Co for Biofresh LIC, P.O. Box 87218, Dubai, U.A.E.). It contains 0.12% Chlorhexidine Digluconate, purified water, sodium saccharin, cremophor, flavor, and glycerin.",[15],[31],{"name":32,"affiliation":33,"role":34},"Zahra H Al-Tamimi, MS student","Department of prevention, College of dentistry , University of Mustansiriyah","PRINCIPAL_INVESTIGATOR",[36,40],{"name":32,"role":37,"phone":38,"phoneExt":24,"email":39},"CONTACT","009647806462936","Zahar94@uomustansiriyah.edu.iq",{"name":32,"role":37,"phone":41,"phoneExt":24,"email":39},"+964 780 031 5235",[43],{"facility":44,"status":45,"city":46,"state":24,"zip":24,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Al-Mustansiriyah University\u002FCollege of Dentistry","RECRUITING","Baghdad","Iraq","IQ",{"type":50,"coordinates":51},"Point",[52,53],44.40088,33.34058,{"lat":53,"lon":52},[56,57,58],{"name":32,"role":37,"phone":38,"phoneExt":24,"email":39},{"name":32,"role":37,"phone":41,"phoneExt":24,"email":39},{"name":32,"role":34,"phone":24,"phoneExt":24,"email":24},{"type":34,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":24,"oldOrganization":24},"ZAHRAA HUSSEIN DAWOOD","Master's Student in Dentistry","100585324","phase-2-role-of-kefir-mouth-wash-in-oral-health-status-amelioration-100585324",false,"NCT06900881","Role of Kefir Mouth Wash in Oral Health Status Amelioration","Role of Kefir Mouth Wash in Oral Health Status Amelioration: An in Vivo Study","Inclusion Criteria:\n\n* Age range 18-28 years.\n* Systemically healthy people without a history of chronic illness.\n* Those suffering with moderate gingivitis.\n* Not using any antibiotics over three months\n\nExclusion Criteria:\n\n* History of systemic diseases.\n* Pregnant, lactating females.\n* History of antibiotic therapy in the past 3 months.\n* History of oral prophylaxis within the last 6 months prior to the study as this can confound the results, making it difficult to determine the real effect of the mouthwash.\n* Subjects with mouth breathing habits.\n* Subjects with orthodontic and prosthodontic appliances.\n* Subjects with deleterious habits such as smoking, because it may affect oral health status, causing periodontal disease, altered oral microbiota, and impaired healing. This can confound the study results, making it difficult to observe the mouthwash effect .\n* Failure to follow the prescription regimen.\n* Failure to follow the research protocol.",true,"ALL","18 Years","28 Years",{"count":74,"type":75},60,"ESTIMATED","INTERVENTIONAL",[78,79],"PHASE2","PHASE3","The present research aims to evaluate the efficiency of kefir mouthwash in enhancing oral health status by employing an in vivo experimental approach. Specifically, the study will assess how kefir mouthwash influences key oral health indicators, including gingival inflammation, plaque development, oral hygiene status, and halitosis. The study will be conducted over a 28-day period, with follow-up assessments every 14 days. The study will include systemically healthy adults with moderate gingivitis. Clinical parameters such as the Gingival Index (GI), Plaque Index (PI), and Simplified Oral Hygiene Index (OHI-S) will be measured, along with inflammatory biomarkers, including Interleukin-1β (IL-1β) and Interleukin-10 (IL-10). Halitosis will be evaluated using a Hali meter device. All of these will be measured at base line and day 14 and day 28 end of the study. Chlorhexidine 0.12% will be used as a comparative control to evaluate the efficacy of kefir mouthwash in improving oral health. This research intends to provide scientific evidence supporting the use of kefir as a probiotic-based mouthwash, offering a natural alternative to chemical mouthwashes and potentially reducing the negative consequences commonly associated with their use.",[82,83,84],"Plaque Induced Gingivitis","Halitosis","Oral Disease",[86,87,83,88,89],"Kefir","Moderate gingivitis","Plaque","Oral Health Status","2025-04-22",{"date":92,"type":93},"2025-04-24","ACTUAL",{"date":95,"type":93},"2025-04-06",{"date":97,"type":75},"2025-10-10",{"name":5,"class":6},1]