Not Yet RecruitingPhase 2ACTRN12614000227695

Unique Manuka Factor (UMF) honey as a subgingival delivery device in the treatment of chronic periodontitis - a pilot study.

Use of manuka honey subgingivally, as an adjunct to scaling and root planing (SRP) versus SRP alone, during treatment of chronic periodontitis in adult patients, in order to reduce probing pocket depths and gingival bleeding; a randomised single-blinded split-mouth clinical trial.

Sponsor

Dr Helen English

Enrollment

6 participants

Start Date

Mar 21, 2014

Study Type

Interventional

Conditions

Periodontitis

Summary

The unique antimicrobial properties of honey are well recognized. Although many honeys display antibacterial effects, the active ingredient thought to be responsible for the unique and superior antibacterial properties of honey obtained from the manuka shrub is methylglyoxal, measured by a Unique Manuka Factor (UMF registered trademark) rating. In recent years local delivery systems containing antibiotics have been introduced as an adjunctive therapy to traditional treatment of periodontal (gum) disease to optimize healing. However, use of a natural product utilising the superior therapeutic potential of our own readily-available New Zealand manuka honey in the treatment of periodontitis may show significant potential. The aim of this study is to compare the effects of manuka honey delivered into the periodontal pocket following scaling and root planing (SRP+UMF), with scaling and root planing alone (SRP). This study is the pilot trial to test the ease of application of the honey and its ability to stay in the pocket. The second phase for which a separate registrations has been made, will recruit 60 patients who fit the inclusion criteria from a private specialist periodontal practice and a single-blind, split-mouth, randomised clinical trial design methodology will be followed. Clinical measurements and microbiological analysis of plaque samples will be analysed for 6 months post-treatment.

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Inclusion Criteria1

Adult patients with chronic periodontitis (two non-molar sites in opposite quadrants with pocket depths greater than or equal to 6mm and bleeding on periodontal probing)

Exclusion Criteria1

Current or recent (<6 months) antibiotic therapy, pregnancy or breastfeeding, uncontrolled diabetes, medical conditions or devices requiring antibiotic prophylaxis, current bisphosphonate therapy, immunocompromised individuals or those with a known hypersensitivity to pollen or bee products.

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Interventions

This pilot study will examine the ease of application of the product, the substantivity of the active manuka honey agent within the periodontal pocket, and the release profile of the proposed Unique Manuka Factor (UMF) agent during a 7-day pharmacokinetic study. Unique Manuka Factor (UMF) Honey will be applied below the gum around teeth with periodontitis, in combination with scaling and root planing (SRP). Each participant will receive full mouth SRP under local anaesthetic in two treatment sessions of one hour per session, over a 24-hour period. 0.05ml of Manuka honey will be delivered using a blunt cannula into the test site immediately after SRP, where possible after the first treatment session.