PMID- 24080100 OWN - NLM STAT- MEDLINE DCOM- 20140813 LR - 20221207 IS - 1559-2030 (Electronic) IS - 1551-7144 (Print) IS - 1551-7144 (Linking) VI - 36 IP - 2 DP - 2013 Nov TI - 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. PG - 515-26 LID - S1551-7144(13)00161-4 [pii] LID - 10.1016/j.cct.2013.09.010 [doi] AB - 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. CI - (c) 2013. Published by Elsevier Inc. All rights reserved. CN - DPTT study group AD - (a)New York University, College of Dentistry, New York, New York 10010, United States. FAU - Engebretson, S AU - Engebretson S FAU - Gelato, M AU - Gelato M FAU - Hyman, L AU - Hyman L FAU - Michalowicz, B S AU - Michalowicz BS FAU - Schoenfeld, E AU - Schoenfeld E LA - eng SI - ClinicalTrials.gov/NCT00997178 GR - U01 DE018886/DE/NIDCR NIH HHS/United States GR - U01 DE018902/DE/NIDCR NIH HHS/United States GR - UO1 DE018902/DE/NIDCR NIH HHS/United States PT - Clinical Trial, Phase III PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial PT - Research Support, N.I.H., Extramural DEP - 20130927 PL - United States TA - Contemp Clin Trials JT - Contemporary clinical trials JID - 101242342 RN - 0 (Blood Glucose) RN - 0 (Glycated Hemoglobin A) RN - 0 (Mouthwashes) RN - 0 (hemoglobin A1c protein, human) SB - IM MH - Blood Glucose/analysis MH - Clinical Protocols MH - Diabetes Mellitus, Type 2/blood/*complications MH - Glycated Hemoglobin/*analysis MH - Humans MH - Mouthwashes/therapeutic use MH - Periodontitis/blood/etiology/*therapy MH - Severity of Illness Index MH - Single-Blind Method PMC - PMC3885354 MID - NIHMS533105 OTO - NOTNLM OT - Diabetes mellitus OT - Glycosylated hemoglobin OT - HbA1c OT - Periodontal disease OT - Periodontitis OT - Type 2 FIR - Engebretson, S IR - Engebretson S FIR - Gelato, M IR - Gelato M FIR - Moonga, B IR - Moonga B FIR - Tenzler, R IR - Tenzler R FIR - Hyman, L IR - Hyman L FIR - Schoenfeld, E IR - Schoenfeld E FIR - Dong, Li Ming IR - Dong LM FIR - Fazzari, Melissa IR - Fazzari M FIR - Hou, W IR - Hou W FIR - Lerner, G IR - Lerner G FIR - Chen, H IR - Chen H FIR - Lee, S IR - Lee S FIR - Knuth, C IR - Knuth C FIR - Mendelsohn, J IR - Mendelsohn J FIR - Pietrzak, G IR - Pietrzak G FIR - Hytner, C IR - Hytner C FIR - Snelling, L IR - Snelling L FIR - Ahmed, S IR - Ahmed S FIR - Rodriguez, M IR - Rodriguez M FIR - Merin, M IR - Merin M FIR - Merin, J IR - Merin J FIR - Merill, L IR - Merill L FIR - Seib, L IR - Seib L FIR - Reddy, M IR - Reddy M FIR - Lewis, C IR - Lewis C FIR - Geurs, N IR - Geurs N FIR - Vassilopoulos, P IR - Vassilopoulos P FIR - Abrahams, A IR - Abrahams A FIR - Doobrow, J IR - Doobrow J FIR - Geisinger, M IR - Geisinger M FIR - Kukunooru, S IR - Kukunooru S FIR - Leavitt, C IR - Leavitt C FIR - Pardo, J IR - Pardo J FIR - Arraj, R Abou IR - Arraj RA FIR - Reganato, A IR - Reganato A FIR - Simmons, K IR - Simmons K FIR - Unger, E IR - Unger E FIR - Bain, J IR - Bain J FIR - Beaudry, K IR - Beaudry K FIR - Nguyen, M IR - Nguyen M FIR - Sauceda, R IR - Sauceda R FIR - Bauerle, J IR - Bauerle J FIR - Madigan, M IR - Madigan M FIR - Ntounis, A IR - Ntounis A FIR - Kaur, M IR - Kaur M FIR - Stevens, A IR - Stevens A FIR - Goggin, S IR - Goggin S FIR - Pitman, L IR - Pitman L FIR - Trammel, K IR - Trammel K FIR - Peterson, C IR - Peterson C FIR - Haigh, S IR - Haigh S FIR - Jackson, J IR - Jackson J FIR - Finch, E IR - Finch E FIR - Akers, S IR - Akers S FIR - Grant, V IR - Grant V FIR - Acharya, S IR - Acharya S FIR - McLean, S IR - McLean S FIR - Turman, J IR - Turman J FIR - Roche, J IR - Roche J FIR - Bragg, C IR - Bragg C FIR - Rajanna, R IR - Rajanna R FIR - Bolton, E IR - Bolton E FIR - Michalowicz, B IR - Michalowicz B FIR - DiAngelis, D IR - DiAngelis D FIR - Seaquist, E IR - Seaquist E FIR - Danielson, J IR - Danielson J FIR - Lenton, P IR - Lenton P FIR - Wolff, L IR - Wolff L FIR - Thibado, P IR - Thibado P FIR - Molletti, S IR - Molletti S FIR - Long-Simpson, L IR - Long-Simpson L FIR - Okorocha, Y IR - Okorocha Y FIR - Hadfield, B IR - Hadfield B FIR - Bartels, L IR - Bartels L FIR - Dunn, C IR - Dunn C FIR - Meyer, K IR - Meyer K FIR - Reibel, K IR - Reibel K FIR - Jordan, A IR - Jordan A FIR - Hedge, R IR - Hedge R FIR - Herrera, O IR - Herrera O FIR - Romero, E IR - Romero E FIR - Mohamed, S IR - Mohamed S FIR - Stull, C IR - Stull C FIR - Oates, T IR - Oates T FIR - Tripathy, D IR - Tripathy D FIR - Alexander, P IR - Alexander P FIR - Lasho, D IR - Lasho D FIR - Gregory, H IR - Gregory H FIR - Huynh-Ba, G IR - Huynh-Ba G FIR - Jordan, J IR - Jordan J FIR - Pena, S IR - Pena S FIR - Pacheco-Vera, C IR - Pacheco-Vera C FIR - Carrera, M IR - Carrera M FIR - Munoz, A IR - Munoz A FIR - Paquette, D IR - Paquette D FIR - Engebretson, S IR - Engebretson S FIR - Gelato, M IR - Gelato M FIR - Sayasith, T IR - Sayasith T FIR - Gu, Y IR - Gu Y FIR - Roth, A IR - Roth A FIR - Urbankova, A IR - Urbankova A FIR - Ryan, M IR - Ryan M FIR - Tuthill, J IR - Tuthill J FIR - Hughes, J IR - Hughes J FIR - Grewal, S IR - Grewal S FIR - Tenzler, R IR - Tenzler R FIR - Houshmand, B IR - Houshmand B FIR - Iacono, V IR - Iacono V FIR - Katancik, J IR - Katancik J FIR - Wang, B IR - Wang B FIR - Orlander, P IR - Orlander P FIR - Eswaran, S IR - Eswaran S FIR - Parthasarathy, K IR - Parthasarathy K FIR - Arastu, A IR - Arastu A FIR - Thomas, R IR - Thomas R FIR - Headley, J IR - Headley J FIR - Cavender, A IR - Cavender A FIR - Harrison, N J IR - Harrison NJ FIR - Dancsak, T IR - Dancsak T FIR - Galpin, M IR - Galpin M FIR - Tsai, M IR - Tsai M FIR - Hanson, N IR - Hanson N FIR - Nowicki, M IR - Nowicki M FIR - Le, V IR - Le V EDAT- 2013/10/02 06:00 MHDA- 2014/08/15 06:00 PMCR- 2014/11/01 CRDT- 2013/10/02 06:00 PHST- 2013/06/25 00:00 [received] PHST- 2013/09/16 00:00 [revised] PHST- 2013/09/18 00:00 [accepted] PHST- 2013/10/02 06:00 [entrez] PHST- 2013/10/02 06:00 [pubmed] PHST- 2014/08/15 06:00 [medline] PHST- 2014/11/01 00:00 [pmc-release] AID - S1551-7144(13)00161-4 [pii] AID - 10.1016/j.cct.2013.09.010 [doi] PST - ppublish SO - Contemp Clin Trials. 2013 Nov;36(2):515-26. doi: 10.1016/j.cct.2013.09.010. Epub 2013 Sep 27.