Therapeutic Effect of Manuka Honey Oral Rinse in Periodontitis Patients Undergoing Hemodialysis

Summary

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.

Conditions

• Periodontitis
• Hemodialysis

Interventions

DIETARY_SUPPLEMENT

Manuka honey oral rinse.

Name: 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

DRUG

Normal saline rinses.

Dosage: 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.

Sponsors & Collaborators

• Ain Shams University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-01

Primary Completion

2025-12-30

Completion

2025-12-30

Countries

• Egypt

Study Locations