Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000227695
Ethics application status
Not yet submitted
Date submitted
20/02/2014
Date registered
4/03/2014
Date last updated
4/03/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Unique Manuka Factor (UMF) honey as a subgingival delivery device in the treatment of chronic periodontitis - a pilot study.
Scientific title
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.
Secondary ID [1] 284133 0
nil
Universal Trial Number (UTN)
U1111-1153-6120
Trial acronym
MAP Pilot study
(Manuka honey for Adjunctive treatment of Periodontitis)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Periodontitis 291214 0
Condition category
Condition code
Oral and Gastrointestinal 291556 291556 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Alternative and Complementary Medicine 291557 291557 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 288827 0
Treatment: Other
Comparator / control treatment
Scaling and rootplaning alone: each participant will receive full mouth SRP under local anaesthetic in two treatment sessions of one hour per session, over a 24-hour period. Control sites receive no additional treatment.
Control group
Active

Outcomes
Primary outcome [1] 291517 0
Gingival crevicular fluid samples will be taken from the periodontal pockets using PerioPaper strips. The presence and activity of methylglyoxal in GCF will be quantified by using the neutralization assay of Kwakman et al. (2011). The strips will be stored at -80 degrees C until assayed, then thawed and centrifuged derivatized for 30 min at room temperature with o-phenylene-diamine to give 2-methylquinoxaline, according to the method of Chaplen et al. (1998). Derivatized samples will be partially purified by solid-phase extraction and subjected to reverse phase chromatography in an HPLC system.
Timepoint [1] 291517 0
Baseline (prior to SRP) and 1, 3, 5 and 7 days after therapy
Primary outcome [2] 291518 0
Subgingival bacterial plaque samples will be taken from the periodontal pockets using a sterile curette. Subgingival plaque samples will be transferred without delay to labeled sterile transport tubes containing phosphate-buffered saline and frozen at-80 degrees C until analysis. A multiplex qRT-PCR assay will be used for the detection and quantification of seven microbial pathogenic species: A actinomycetemcomitans, P gingivalis, P intermedia, T forsythia, F nucleatum, T denticola and S aureus. Species-specific PCR primers and TaqMan probes will be designed and synthesised as described by Suzuki et al (2004). The microbial species will be quantified using the cycle threshold (^^Ct) method as described by Joyce (2002). Oral samples will be treated with InstaGene Matrix (Bio Rad) and small aliquots (in duplicate) will be subjected to TaqMan-based mqRT-PCR using the ABI 7500 Fast Real-Time qPCR System.
Timepoint [2] 291518 0
Baseline (prior to SRP) and 1, 3, 5 and 7 days after therapy
Secondary outcome [1] 306941 0
Clinical indices consisting of Plaque Index (PI), Pocket Depth (PD), Clinical Attachment Level (CAL) and Bleeding on Probing (BOP) parameters will be recorded at all time intervals at both sites using a periodontal probe with Williams markings and 20g force.
Timepoint [1] 306941 0
Baseline (prior to SRP) and 1, 3, 5 and 7 days after therapy

Eligibility
Key inclusion criteria
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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Study participants will be recruited from the periodontal patient population at a private specialist periodontal practice in Nelson, New Zealand). A split mouth design will be used, with treatments allocated randomly to either site; patients will not be informed which site is the test site. Allocation of sites will be determined by a second clinician (hygienist) and delivered using sealed opaque envelopes; allocation will be concealed from the primary clinician.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Two experimental sites will be randomly allocated at the split-mouth level by a computer-generated table into either the test group (SRP+UMF) or the control group (SRP alone)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Single group, split mouth(pilot study)
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistical analyses of the changes in the clinical and microbiological parameters will be employed using Mann-Whitney U tests (P <0.05) and one-way analysis of variance tests (ANOVA).
This is a pre-trial pilot study using six individuals; results will determine the sample size for the main trial (see separate trial registration)

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/03/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment outside Australia
Country [1] 5844 0
New Zealand
State/province [1] 5844 0
Nelson

Funding & Sponsors
Funding source category [1] 288764 0
Charities/Societies/Foundations
Name [1] 288764 0
New Zealand Dental Association Research Foundation
Country [1] 288764 0
New Zealand
Primary sponsor type
Individual
Name
Dr Helen English
Address
Nelson Periodontics
2 Brougham St Nelson 7010
Country
New Zealand
Secondary sponsor category [1] 287461 0
Individual
Name [1] 287461 0
Associate Professor Warwick Duncan
Address [1] 287461 0
Director, Clinical Research Group Sir John Walsh Research Institute University of Otago School of Dentistry
PO Box 647 University of Otago Dunedin 9054
Country [1] 287461 0
New Zealand
Secondary sponsor category [2] 287462 0
Individual
Name [2] 287462 0
Associate Professor Patrick Schmidlin
Address [2] 287462 0
Head of Periodontics
University of Zurich
Zentrum fur Zahnmedizin (Center for Dentistry) Plattenstrasse 11
8032 Zurich
Country [2] 287462 0
Switzerland

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 290606 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 290606 0
Ministry of Health No 1 The Terrace PO Box 5013 Wellington 6011
Ethics committee country [1] 290606 0
New Zealand
Date submitted for ethics approval [1] 290606 0
21/02/2014
Approval date [1] 290606 0
Ethics approval number [1] 290606 0

Summary
Brief 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 46398 0
Dr Helen English
Address 46398 0
Nelson Periodontics 2 Brougham St Nelson 7010
Country 46398 0
New Zealand
Phone 46398 0
6435489955
Fax 46398 0
Email 46398 0
[email protected]
Contact person for public queries
Name 46399 0
Dr Helen English
Address 46399 0
Nelson Periodontics 2 Brougham St Nelson 7010
Country 46399 0
New Zealand
Phone 46399 0
6435489955
Fax 46399 0
Email 46399 0
[email protected]
Contact person for scientific queries
Name 46400 0
A/Prof Warwick Duncan
Address 46400 0
Faculty of Dentistry PO Box 647 University of Otago Dunedin 9054 New Zealand
Country 46400 0
New Zealand
Phone 46400 0
6434797110
Fax 46400 0
Email 46400 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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