Therapeutic Effect of Manuka Honey Oral Rinse in Periodontitis Patients Undergoing Hemodialysis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAin Shams University
About this trial
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.
Periodontitis 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.
Alternative 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.
Previous 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Manuka honey oral rinse.
Dietary supplementName: Manuka Honey Oral Rinse Description: Dosage: Patients will use 20 ml of Manuka honey diluted in 100 ml of purified water. Administration: Oral rinse, performed 3 times per day. Instructions: Patients are instructed to rinse their mouths with the solution for a specified duration and avoid swallowing it. Unique Elements: Active Ingredient: Manuka honey, known for its unique antibacterial properties due to high levels of methylglyoxal (MGO). Mechanism 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. Additional 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. Supplementary Care: Patients receive motivation and detailed oral hygiene instructions (proper tooth brushing technique, flossing, use of inte
Normal saline rinses.
DrugDosage: Patients will use 20 ml of normal saline. Administration: Oral rinse, performed 3 times per day. Instructions: Patients are instructed to rinse their mouths with the saline solution for a specified duration and avoid swallowing it. Unique Elements: Control Comparison: Provides a placebo comparison to evaluate the efficacy of the Manuka honey intervention. Additional 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.
Treatment groups
150 Participants
are divided into 2 treatment groupsGroup A: Control GroupPlacebo comparator 1 intervention
Group B: Intervention GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Clinical Attachment Level (CAL)
Description: Measurement of the attachment level of the periodontal ligament to the tooth surface, indicating the health of periodontal tissues.
Time frame
Evaluated at baseline, 3 months, and 6 months post-treatment.Secondary outcomes
1
Bleeding on Probing (BOP)
Description: Assessment of bleeding on probing, which is an indicator of inflammation in periodontal tissues.
Time frame
Evaluated at baseline, 3 months, and 6 months post-treatment.2
Plaque Index
Measurement of the amount of dental plaque on the tooth surface, which is an indicator of oral hygiene.
Time frame
Evaluated at baseline, 3 months, and 6 months post-treatment.3
Fibroblast Growth Factor 23 (FGF 23) Levels in Gingival Crevicular Fluid (GCF)
Measurement of FGF 23 levels in gingival crevicular fluid, which may reflect tissue response and inflammation levels.
Time frame
Evaluated at baseline and at 6 months post-treatment.4
Fibroblast Growth Factor 23 (FGF 23) Levels in serum
Measurement of FGF 23 levels in serum, which may reflect tissue response and inflammation levels.
Time frame
Evaluated at baseline and at 6 months post-treatment.Sponsors and contacts
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Source ClinicalTrials.gov