Design features of the Diabetes and Periodontal Therapy Trial (DPTT): a multicenter randomized single-masked clinical trial testing the effect of nonsurgical periodontal therapy on glycosylated hemoglobin (HbA1c) levels in subjects with type 2 diabetes and chronic periodontitis

DPTT study group, S Engebretson, M Gelato, L Hyman, B S Michalowicz, E Schoenfeld, S Engebretson, M Gelato, B Moonga, R Tenzler, L Hyman, E Schoenfeld, Li Ming Dong, Melissa Fazzari, W Hou, G Lerner, H Chen, S Lee, C Knuth, J Mendelsohn, G Pietrzak, C Hytner, L Snelling, S Ahmed, M Rodriguez, M Merin, J Merin, L Merill, L Seib, M Reddy, C Lewis, N Geurs, P Vassilopoulos, A Abrahams, J Doobrow, M Geisinger, S Kukunooru, C Leavitt, J Pardo, R Abou Arraj, A Reganato, K Simmons, E Unger, J Bain, K Beaudry, M Nguyen, R Sauceda, J Bauerle, M Madigan, A Ntounis, M Kaur, A Stevens, S Goggin, L Pitman, K Trammel, C Peterson, S Haigh, J Jackson, E Finch, S Akers, V Grant, S Acharya, S McLean, J Turman, J Roche, C Bragg, R Rajanna, E Bolton, B Michalowicz, D DiAngelis, E Seaquist, J Danielson, P Lenton, L Wolff, P Thibado, S Molletti, L Long-Simpson, Y Okorocha, B Hadfield, L Bartels, C Dunn, K Meyer, K Reibel, A Jordan, R Hedge, O Herrera, E Romero, S Mohamed, C Stull, T Oates, D Tripathy, P Alexander, D Lasho, H Gregory, G Huynh-Ba, J Jordan, S Pena, C Pacheco-Vera, M Carrera, A Munoz, D Paquette, S Engebretson, M Gelato, T Sayasith, Y Gu, A Roth, A Urbankova, M Ryan, J Tuthill, J Hughes, S Grewal, R Tenzler, B Houshmand, V Iacono, J Katancik, B Wang, P Orlander, S Eswaran, K Parthasarathy, A Arastu, R Thomas, J Headley, A Cavender, N J Harrison, T Dancsak, M Galpin, M Tsai, N Hanson, M Nowicki, V Le, DPTT study group, S Engebretson, M Gelato, L Hyman, B S Michalowicz, E Schoenfeld, S Engebretson, M Gelato, B Moonga, R Tenzler, L Hyman, E Schoenfeld, Li Ming Dong, Melissa Fazzari, W Hou, G Lerner, H Chen, S Lee, C Knuth, J Mendelsohn, G Pietrzak, C Hytner, L Snelling, S Ahmed, M Rodriguez, M Merin, J Merin, L Merill, L Seib, M Reddy, C Lewis, N Geurs, P Vassilopoulos, A Abrahams, J Doobrow, M Geisinger, S Kukunooru, C Leavitt, J Pardo, R Abou Arraj, A Reganato, K Simmons, E Unger, J Bain, K Beaudry, M Nguyen, R Sauceda, J Bauerle, M Madigan, A Ntounis, M Kaur, A Stevens, S Goggin, L Pitman, K Trammel, C Peterson, S Haigh, J Jackson, E Finch, S Akers, V Grant, S Acharya, S McLean, J Turman, J Roche, C Bragg, R Rajanna, E Bolton, B Michalowicz, D DiAngelis, E Seaquist, J Danielson, P Lenton, L Wolff, P Thibado, S Molletti, L Long-Simpson, Y Okorocha, B Hadfield, L Bartels, C Dunn, K Meyer, K Reibel, A Jordan, R Hedge, O Herrera, E Romero, S Mohamed, C Stull, T Oates, D Tripathy, P Alexander, D Lasho, H Gregory, G Huynh-Ba, J Jordan, S Pena, C Pacheco-Vera, M Carrera, A Munoz, D Paquette, S Engebretson, M Gelato, T Sayasith, Y Gu, A Roth, A Urbankova, M Ryan, J Tuthill, J Hughes, S Grewal, R Tenzler, B Houshmand, V Iacono, J Katancik, B Wang, P Orlander, S Eswaran, K Parthasarathy, A Arastu, R Thomas, J Headley, A Cavender, N J Harrison, T Dancsak, M Galpin, M Tsai, N Hanson, M Nowicki, V Le

Abstract

Background: Evidence suggests that periodontitis is associated with prevalent and incident type 2 diabetes mellitus (T2DM), raising the question of whether periodontitis treatment may improve glycemic control in patients with T2DM. Meta-analyses of mostly small clinical trials suggest that periodontitis treatment results in a modest reduction in glycosylated hemoglobin (Hb) A1c.

Purpose: The purpose of the Diabetes and Periodontal Therapy Trial (DPTT) was to determine if periodontal treatment reduces HbA1c in patients with T2DM and periodontitis.

Methods: DPTT was a phase-III, single-masked, multi-center, randomized trial with a planned enrollment of 600 participants. Participants were randomly assigned to receive periodontal treatment immediately (Treatment Group) or after 6 months (Control Group). HbA1c values and clinical periodontal measures were determined at baseline and 3 and 6 months following randomization. Medication usage and dosing were assessed at each visit. Periodontal treatment consisted of scaling and root planing for a minimum of two 90-minute sessions, plus the use of an antibacterial mouth rinse for at least 32 days afterwards. The primary outcome was change in HbA1c from baseline to 6 months and the trial was powered to detect a between-group difference of 0.6%. Secondary outcomes included changes in periodontal clinical measures, fasting plasma glucose, the Homeostasis Model Assessment (HOMA2) and the need for rescue diabetes or periodontal therapy.

Conclusion: Dental and medical researchers collaborated to recruit, treat and monitor participants with two chronic diseases to determine if treatment of one condition affects the status of the other.

Trial registration: ClinicalTrials.gov NCT00997178.

Keywords: Diabetes mellitus; Glycosylated hemoglobin; HbA1c; Periodontal disease; Periodontitis; Type 2.

© 2013. Published by Elsevier Inc. All rights reserved.

Figures

FIGURE 1
FIGURE 1
FIGURE SCHEMATIC OF DPTT STUDY DESIGN

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