Manuka honey mouth rinse for people on hemodialysis with periodontitis
Therapeutic Effect of Manuka Honey Oral Rinse in Periodontitis Patients Undergoing Hemodialysis
This tests whether a Manuka honey mouth rinse can improve gum disease in adults with end-stage kidney disease who are receiving hemodialysis.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ain Shams University Academic / other |
| Locations | 1 site (Banhā) |
| Trial ID | NCT06726876 on ClinicalTrials.gov |
What this trial studies
This Phase 3 interventional study enrolls adults with end-stage renal disease on hemodialysis who have clinical periodontitis. Participants will use either a Manuka honey oral rinse or a normal saline rinse as an adjunct to standard non-surgical periodontal care, and clinical periodontal measures will be tracked over the treatment period. The protocol includes monitoring of oral health outcomes and biomarkers related to inflammation and healing, including fibroblast growth factor-21. Safety, tolerability, and changes in periodontal infection and inflammation are captured as study endpoints.
Who should consider this trial
Good fit: Adults (18+) with end-stage renal disease on hemodialysis who have clinically diagnosed periodontitis, can provide reliable consent, and meet the study's exclusion criteria are eligible.
Not a fit: People who smoke, have active malignancy, autoimmune disease, a history of kidney transplant, pregnancy, known allergy to honey, or who do not have periodontitis or are not on hemodialysis are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, the rinse could reduce gum inflammation and bacterial burden, improving oral health and nutritional status in dialysis patients.
How similar studies have performed: Laboratory and small clinical studies suggest Manuka honey has antimicrobial and wound-healing effects, but strong clinical evidence of benefit for periodontitis—particularly in dialysis patients—is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Both genders, aged above 18 years. * All patients must be clinically diagnosed of ESRD undergoing hemodialysis. * All patients must have a periodontal disease. * Patients must be able to make reliable decision or communications. Exclusion Criteria: * Smoking, Alcohol. * Patient with history of any serious illness as malignancy, who undergo kidney transplant. * Patients with any autoimmune disease. * Vulnerable groups such as pregnant females, prisoners, mentally and physically handicapped individuals. * Known hypersensitivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation.
Where this trial is running
Banhā
- Benha hospital — Banhā, Egypt (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.