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

The 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 & 31 others 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, J. Katancik

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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 antibacterialmouth rinse for at least 32 days afterwards. The primary outcomewas 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.

LanguageEnglish (US)
Pages515-526
Number of pages12
JournalContemporary Clinical Trials
Volume36
Issue number2
DOIs
StatePublished - 2013
Externally publishedYes

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Chronic Periodontitis
Glycosylated Hemoglobin A
Type 2 Diabetes Mellitus
Multicenter Studies
Clinical Trials
Periodontitis
Therapeutics
Root Planing
Needs Assessment
Random Allocation
Meta-Analysis
Fasting
Tooth
Homeostasis
Chronic Disease
Research Personnel
Glucose

Keywords

  • Diabetes mellitus
  • Glycosylated hemoglobin
  • HbA1c
  • Periodontal disease
  • Periodontitis
  • Type 2

ASJC Scopus subject areas

  • Medicine(all)
  • Pharmacology (medical)

Cite this

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title = "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",
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 antibacterialmouth rinse for at least 32 days afterwards. The primary outcomewas 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.",
keywords = "Diabetes mellitus, Glycosylated hemoglobin, HbA1c, Periodontal disease, Periodontitis, Type 2",
author = "{The DPTT study group} and S. Engebretson and M. Gelato and L. Hyman and Michalowicz, {B. S.} and E. Schoenfeld and S. Engebretson and M. Gelato and B. Moonga and R. Tenzler and L. Hyman and E. Schoenfeld and Dong, {Li Ming} and Melissa Fazzari and W. Hou and G. Lerner and H. Chen and S. Lee and C. Knuth and J. Mendelsohn and G. Pietrzak and C. Hytner and L. Snelling and S. Ahmed and M. Rodriguez and M. Merin and J. Merin and L. Merill and L. Seib and M. Reddy and C. Lewis and N. Geurs and P. Vassilopoulos and A. Abrahams and J. Doobrow and M. Geisinger and S. Kukunooru and C. Leavitt and J. Pardo and {Abou Arraj}, R. and A. Reganato and K. Simmons and E. Unger and J. Bain and K. Beaudry and M. Nguyen and R. Sauceda and J. Bauerle and M. Madigan and A. Ntounis and J. Katancik",
year = "2013",
doi = "10.1016/j.cct.2013.09.010",
language = "English (US)",
volume = "36",
pages = "515--526",
journal = "Contemporary Clinical Trials",
issn = "1551-7144",
publisher = "Elsevier Inc.",
number = "2",

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TY - JOUR

T1 - Design features of the diabetes and periodontal therapy trial (DPTT)

T2 - Contemporary Clinical Trials

AU - The DPTT study group

AU - Engebretson,S.

AU - Gelato,M.

AU - Hyman,L.

AU - Michalowicz,B. S.

AU - Schoenfeld,E.

AU - Engebretson,S.

AU - Gelato,M.

AU - Moonga,B.

AU - Tenzler,R.

AU - Hyman,L.

AU - Schoenfeld,E.

AU - Dong,Li Ming

AU - Fazzari,Melissa

AU - Hou,W.

AU - Lerner,G.

AU - Chen,H.

AU - Lee,S.

AU - Knuth,C.

AU - Mendelsohn,J.

AU - Pietrzak,G.

AU - Hytner,C.

AU - Snelling,L.

AU - Ahmed,S.

AU - Rodriguez,M.

AU - Merin,M.

AU - Merin,J.

AU - Merill,L.

AU - Seib,L.

AU - Reddy,M.

AU - Lewis,C.

AU - Geurs,N.

AU - Vassilopoulos,P.

AU - Abrahams,A.

AU - Doobrow,J.

AU - Geisinger,M.

AU - Kukunooru,S.

AU - Leavitt,C.

AU - Pardo,J.

AU - Abou Arraj,R.

AU - Reganato,A.

AU - Simmons,K.

AU - Unger,E.

AU - Bain,J.

AU - Beaudry,K.

AU - Nguyen,M.

AU - Sauceda,R.

AU - Bauerle,J.

AU - Madigan,M.

AU - Ntounis,A.

AU - Katancik,J.

PY - 2013

Y1 - 2013

N2 - 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 antibacterialmouth rinse for at least 32 days afterwards. The primary outcomewas 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.

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 antibacterialmouth rinse for at least 32 days afterwards. The primary outcomewas 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.

KW - Diabetes mellitus

KW - Glycosylated hemoglobin

KW - HbA1c

KW - Periodontal disease

KW - Periodontitis

KW - Type 2

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U2 - 10.1016/j.cct.2013.09.010

DO - 10.1016/j.cct.2013.09.010

M3 - Article

VL - 36

SP - 515

EP - 526

JO - Contemporary Clinical Trials

JF - Contemporary Clinical Trials

SN - 1551-7144

IS - 2

ER -