[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571947":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":32,"responsibleParty":51,"collaborators":26,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":26,"eligibilityCriteria":60,"healthyVolunteers":57,"sex":61,"minAge":62,"maxAge":26,"enrollmentInfo":63,"targetDuration":26,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":73,"overallStatus":35,"whyStopped":26,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Ain Shams University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Control Group","PLACEBO_COMPARATOR","Treatment: Normal saline rinse.\n\nProtocol:\n\nFollow the same protocol as the intervention group but using normal saline rinses instead of Manuka honey.\n\nAdditional Treatment: Patients will receive scaling and root debridement and locally delivered 0.5 ml non-diluted Thyme honey on sites with PPD ≥ 5 mm.\n\nSupplementary Care: Motivation, oral hygiene instructions (proper tooth brushing technique, flossing, interdental brush, mouthwash usage), scaling, polishing, and root debridement with an ultrasonic scaler and Gracey curettes.",[13],"Drug: Normal saline rinses.",{"label":15,"type":16,"description":17,"interventionNames":18},"Intervention Group","EXPERIMENTAL","Treatment: Manuka honey oral rinse.\n\nProtocol:\n\nApplied as an oral rinse based on the Biswal et al. administration protocol.\n\nPatients will have oral rinses (20 ml of Manuka honey diluted in 100 ml of purified water) 3 times per day.\n\nPatients will be instructed not to swallow the Manuka honey oral rinse.\n\nAdditional Treatment: Patients will receive scaling and root debridement and locally delivered 0.5 ml non-diluted Thyme honey on sites with PPD ≥ 5 mm.\n\nSupplementary Care: Motivation, oral hygiene instructions (proper tooth brushing technique, flossing, interdental brush, mouthwash usage), scaling, polishing, and root debridement with an ultrasonic scaler and Gracey curettes.",[19],"Dietary Supplement: Manuka honey oral rinse.",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","Manuka honey oral rinse.","Name: Manuka Honey Oral Rinse\n\nDescription:\n\nDosage: Patients will use 20 ml of Manuka honey diluted in 100 ml of purified water.\n\nAdministration: Oral rinse, performed 3 times per day.\n\nInstructions: Patients are instructed to rinse their mouths with the solution for a specified duration and avoid swallowing it.\n\nUnique Elements:\n\nActive Ingredient: Manuka honey, known for its unique antibacterial properties due to high levels of methylglyoxal (MGO).\n\nMechanism of Action: MGO and Non-Peroxide Activity (NPA) contribute to antibacterial potency, effective against antibiotic-resistant bacteria, and potential immunomodulatory effects that aid wound healing and tissue regeneration.\n\nAdditional Procedures: Scaling and root debridement, along with the local application of 0.5 ml non-diluted Thyme honey on sites with Probing Pocket Depth (PPD) ≥ 5 mm.\n\nSupplementary Care: Patients receive motivation and detailed oral hygiene instructions (proper tooth brushing technique, flossing, use of inte",[15],null,{"type":28,"name":29,"description":30,"armGroupLabels":31,"otherNames":26},"DRUG","Normal saline rinses.","Dosage: Patients will use 20 ml of normal saline.\n\nAdministration: Oral rinse, performed 3 times per day.\n\nInstructions: Patients are instructed to rinse their mouths with the saline solution for a specified duration and avoid swallowing it.\n\nUnique Elements:\n\nControl Comparison: Provides a placebo comparison to evaluate the efficacy of the Manuka honey intervention.\n\nAdditional Procedures: Scaling and root debridement, along with the local application of 0.5 ml non-diluted Thyme honey on sites with Probing Pocket Depth (PPD) ≥ 5 mm.",[9],[33],{"facility":34,"status":35,"city":36,"state":26,"zip":26,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Benha hospital","RECRUITING","Banhā","Egypt","EG",{"type":40,"coordinates":41},"Point",[42,43],31.1842,30.45977,{"lat":43,"lon":42},[46],{"name":47,"role":48,"phone":49,"phoneExt":26,"email":50},"Asmaa Bakr elshaf3y","CONTACT","01000093885","Asmaa.AbdAlRaouf@gu.edu.eg",{"type":52,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Fatma ElSayed","assistant professor","100571947","phase-3-therapeutic-effect-of-manuka-honey-oral-rinse-in-periodontitis-patients-undergoing-hemodialysis-100571947",false,"NCT06726876","Therapeutic Effect of Manuka Honey Oral Rinse in Periodontitis Patients Undergoing Hemodialysis","Inclusion Criteria:\n\n* Both genders, aged above 18 years.\n* All patients must be clinically diagnosed of ESRD undergoing hemodialysis.\n* All patients must have a periodontal disease.\n* Patients must be able to make reliable decision or communications.\n\nExclusion Criteria:\n\n* Smoking, Alcohol.\n* Patient with history of any serious illness as malignancy, who undergo kidney transplant.\n* Patients with any autoimmune disease.\n* Vulnerable groups such as pregnant females, prisoners, mentally and physically handicapped individuals.\n* Known hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation.","ALL","18 Years",{"count":64,"type":65},150,"ESTIMATED","INTERVENTIONAL",[68],"PHASE3","Chronic Kidney Disease (CKD) has a strong association with chronic periodontitis, an oral disease causing tooth loss linked to inflammation and malnutrition. While periodontitis affects 12.7% of the general population, its prevalence can rise to 39% in certain racial groups, and a dose-response relationship exists with CKD. End Stage Renal Disease (ESRD) patients show a prevalence of periodontitis ranging from 29% to 85.6%. Uremia, immunosuppression, and vitamin D deficiency are suggested factors in the etiology of periodontitis in CKD patients, with uremic toxins potentially altering the oral ecosystem.\n\nPeriodontitis involves bacterial biofilm and Gram-negative anaerobes as primary etiological factors. The main treatment goal is to reduce periodontal pathogens and control inflammation, with non-surgical periodontal therapy (NSPT) being the standard. Although various adjuncts like antibiotics and antiseptics are suggested, recent guidelines only recommend certain locally administered agents and systemic antibiotics for specific groups due to increasing bacterial resistance.\n\nAlternative treatments like honey have gained interest, particularly Manuka honey, known for its antibacterial properties against antibiotic-resistant bacteria. This honey's effectiveness is due to its high sugar concentration, low pH, and formation of hydrogen peroxide. Manuka honey's unique component, methylglyoxal (MGO), is a potent bactericide, virucide, and fungicide, linked to its Non-Peroxide Activity (NPA) and Unique Manuka Factor (UMF) rating. MGO also has immunomodulatory effects beneficial for wound healing and tissue regeneration.\n\nPrevious studies show Manuka honey as a promising adjunct in NSPT, improving outcomes significantly without adverse effects. Ongoing research aims to evaluate its effects in ESRD patients on hemodialysis, focusing on clinical attachment levels, other periodontal parameters, and FGF 21 levels in gingival crevicular fluid.",[71,72],"Periodontitis","Hemodialysis",[74,75,76,77],"Manuka honey","fibroblast growth factor-21","periodontitis","hemodialysis","2025-12-26",{"date":80,"type":81},"2025-12-31","ACTUAL",{"date":83,"type":81},"2024-10-01",{"date":85,"type":65},"2025-12-30",{"name":5,"class":6},1]