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

INTERVENTION: 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. CONDITION: Periodontitis PRIMARY OUTCOME: 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. 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. SECONDARY OUTCOME: 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. 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)