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

NCT06726876 | Recruiting Phase 3

• 1 other identifier: R626
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Manuka honey; fibroblast growth factor-21; periodontitis; hemodialysis

Outcome Measures

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.

  Evaluated at baseline, 3 months, and 6 months post-treatment.

Secondary Outcomes (6)

• Bleeding on Probing (BOP)

  Evaluated at baseline, 3 months, and 6 months post-treatment.

• Plaque Index

  Evaluated at baseline, 3 months, and 6 months post-treatment.

• Fibroblast Growth Factor 23 (FGF 23) Levels in Gingival Crevicular Fluid (GCF)

  Evaluated at baseline and at 6 months post-treatment.

• Fibroblast Growth Factor 23 (FGF 23) Levels in serum

  Evaluated at baseline and at 6 months post-treatment.

• Oral Health Impact Profile (OHIP-14) scores

  baseline, and 6 months

Study Arms (2)

Control Group

PLACEBO COMPARATOR

Treatment: Normal saline rinse. Protocol: Follow the same protocol as the intervention group but using normal saline rinses instead of Manuka honey. Additional Treatment: Patients will receive scaling and root debridement and locally delivered 0.5 ml non-diluted Thyme honey on sites with PPD ≥ 5 mm. Supplementary 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.

Drug: Normal saline rinses.

Intervention Group

EXPERIMENTAL

Treatment: Manuka honey oral rinse. Protocol: Applied as an oral rinse based on the Biswal et al. administration protocol. Patients will have oral rinses (20 ml of Manuka honey diluted in 100 ml of purified water) 3 times per day. Patients will be instructed not to swallow the Manuka honey oral rinse. Additional Treatment: Patients will receive scaling and root debridement and locally delivered 0.5 ml non-diluted Thyme honey on sites with PPD ≥ 5 mm. Supplementary 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.

Dietary Supplement: Manuka honey oral rinse.

Interventions

Manuka honey oral rinse. DIETARY_SUPPLEMENT

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

Intervention Group

Normal saline rinses. DRUG

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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Benha hospital

Banhā, Egypt

RECRUITING

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 10, 2024
• Study Start: October 1, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: December 31, 2025

Record last verified: 2025-12

Locations

EG (1)