Periodontitis and type 2 diabetes mellitus

INTERVENTION: Participants will be randomly assigned to either usual periodontal care (supragingival scaling and polishing) or to an intensive periodontal treatment (test group). Blood samples will be collected at almost every visit to assess glucose control between study groups. Samples will also be collected to assess the changes in wound healing and blood vessel health before and after gum therapy in both groups. A subgroup of 30 participants will also undergo more detailed analysis of gingival wound healing processes after periodontal therapy. Study follow‐up is at 12 months. Study entry: single randomisation only Contact details for Patient Information Material: Eastman Clinical Investigation Centre 256 Gray's Inn Road London, WC1X 8LD United Kingdom Tel: +44 (0)20 7915 2334 Fax: +44 (0)20 7915 1213 CONDITION: Topic: Diabetes Research Network, Oral and Gastrointestinal; Subtopic: Type 2, Oral and Gastrointestinal (all Subtopics); Disease: Cardiovascular disease, Diabetic Control, Other, Oral & Dental ; Nutritional, Metabolic, Endocrine ; Diabetes mellitus PRIMARY OUTCOME: Change in HbA1c between test and control group after 12 months of completion of therapy SECONDARY OUTCOME: Current secondary outcome measures as of 26/09/2017:; 1. HbA1c difference at 6 months; 2. Glucose, insulin, creatinine and flow‐mediated dilatation at 6 and 12 months; 3. Adverse events at any study visits ; 4. Periodontal clinical parameters, lipid fractions, inflammatory and endothelial cell surface markers at 2, 6 and 12 months; 5. eGFR and patient reported outcomes at 12 months ; 6. Changes in dental plaque composition at 2, 6 and 12 months visits ; 7. Laser Doppler flowmetry of the skin at all study visits, a subgroup of 30 patients will also have laser Doppler measures of their gums following intensive gum therapy; 8. Intima‐media thickness and endothelium pulse amplitude tonometry changes at 12 months (subgroup of 115 patients); ; Previous secondary outcome measures:; 1. To assess the impact of extensive periodontal therapy on:; 1.1. Markers of gingival wound healing; 1.2. Assessment of endothelial function; 1.3. Subclinical atherosclerosis; 1.4. Systemic inflammation; 1.5. Proteinuria; 1.6. Microbiological differences ; In individuals with type 2 diabetes compared to control; 2. To assess changes in quality of life, both related to diabetes and oral health, after extensive periodontal therapy compared to control INCLUSION CRITERIA: 1. Subject aged over 18 years, either sex 2. Subject diagnosed with type 2 diabetes mellitus 3. Subject consenting to the study 4. Subject with signs of active moderate to severe periodontitis (at least 20 periodontal pockets, probing pocket depth [PPD] greater than 4 mm and bleeding on probing) 5. Minimum of 15 teeth present