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

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 & 113 others 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, R. Weltman, M. Wehmeyer, A. Arastu, R. Thomas, J. Headley, A. Cavender, N. J. Harrison, T. Dancsak, M. Galpin, M. Ruscheinksy, M. Tsai, N. Hanson, M. Nowicki, V. Le,

Research output: Research - peer-reviewArticle

  • 14 Citations

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

Fingerprint

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

Keywords

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

ASJC Scopus subject areas

  • Medicine(all)
  • Pharmacology (medical)

Cite this

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

In: Contemporary Clinical Trials, Vol. 36, No. 2, 2013, p. 515-526.

Research output: Research - peer-reviewArticle

Engebretson, S, Gelato, M, Hyman, L, Michalowicz, BS, Schoenfeld, E, Engebretson, S, Gelato, M, Moonga, B, Tenzler, R, Hyman, L, Schoenfeld, E, Dong, LM, Fazzari, M, Hou, W, Lerner, G, Chen, H, Lee, S, Knuth, C, Mendelsohn, J, Pietrzak, G, Hytner, C, Snelling, L, Ahmed, S, Rodriguez, M, Merin, M, Merin, J, Merill, L, Seib, L, Reddy, M, Lewis, C, Geurs, N, Vassilopoulos, P, Abrahams, A, Doobrow, J, Geisinger, M, Kukunooru, S, Leavitt, C, Pardo, J, Abou Arraj, R, Reganato, A, Simmons, K, Unger, E, Bain, J, Beaudry, K, Nguyen, M, Sauceda, R, Bauerle, J, Madigan, M, Ntounis, A, Kaur, M, Stevens, A, Goggin, S, Pitman, L, Trammel, K, Peterson, C, Haigh, S, Jackson, J, Finch, E, Akers, S, Grant, V, Acharya, S, McLean, S, Turman, J, Roche, J, Bragg, C, Rajanna, R, Bolton, E, Michalowicz, B, Diangelis, D, Seaquist, E, Danielson, J, Lenton, P, Wolff, L, Thibado, P, Molletti, S, Long-Simpson, L, Okorocha, Y, Hadfield, B, Bartels, L, Dunn, C, Meyer, K, Reibel, K, Jordan, A, Hedge, R, Herrera, O, Romero, E, Mohamed, S, Stull, C, Oates, T, Tripathy, D, Alexander, P, Lasho, D, Gregory, H, Huynh-Ba, G, Jordan, J, Pena, S, Pacheco-Vera, C, Carrera, M, Munoz, A, Paquette, D, Engebretson, S, Gelato, M, Sayasith, T, Gu, Y, Roth, A, Urbankova, A, Ryan, M, Tuthill, J, Hughes, J, Grewal, S, Tenzler, R, Houshmand, B, Iacono, V, Katancik, J, Wang, B, Orlander, P, Eswaran, S, Parthasarathy, K, Weltman, R, Wehmeyer, M, Arastu, A, Thomas, R, Headley, J, Cavender, A, Harrison, NJ, Dancsak, T, Galpin, M, Ruscheinksy, M, Tsai, M, Hanson, N, Nowicki, M, Le, V & The DPTT study group 2013, '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' Contemporary Clinical Trials, vol 36, no. 2, pp. 515-526. DOI: 10.1016/j.cct.2013.09.010
Engebretson, S. ; Gelato, M. ; Hyman, L. ; Michalowicz, B. S. ; Schoenfeld, E. ; Engebretson, S. ; Gelato, M. ; Moonga, B. ; Tenzler, R. ; Hyman, L. ; Schoenfeld, E. ; Dong, Li Ming ; Fazzari, Melissa ; Hou, W. ; Lerner, G. ; Chen, H. ; Lee, S. ; Knuth, C. ; Mendelsohn, J. ; Pietrzak, G. ; Hytner, C. ; Snelling, L. ; Ahmed, S. ; Rodriguez, M. ; Merin, M. ; Merin, J. ; Merill, L. ; Seib, L. ; Reddy, M. ; Lewis, C. ; Geurs, N. ; Vassilopoulos, P. ; Abrahams, A. ; Doobrow, J. ; Geisinger, M. ; Kukunooru, S. ; Leavitt, C. ; Pardo, J. ; Abou Arraj, R. ; Reganato, A. ; Simmons, K. ; Unger, E. ; Bain, J. ; Beaudry, K. ; Nguyen, M. ; Sauceda, R. ; Bauerle, J. ; Madigan, M. ; Ntounis, A. ; Kaur, M. ; Stevens, A. ; Goggin, S. ; Pitman, L. ; Trammel, K. ; Peterson, C. ; Haigh, S. ; Jackson, J. ; Finch, E. ; Akers, S. ; Grant, V. ; Acharya, S. ; McLean, S. ; Turman, J. ; Roche, J. ; Bragg, C. ; Rajanna, R. ; Bolton, E. ; Michalowicz, B. ; Diangelis, D. ; Seaquist, E. ; Danielson, J. ; Lenton, P. ; Wolff, L. ; Thibado, P. ; Molletti, S. ; Long-Simpson, L. ; Okorocha, Y. ; Hadfield, B. ; Bartels, L. ; Dunn, C. ; Meyer, K. ; Reibel, K. ; Jordan, A. ; Hedge, R. ; Herrera, O. ; Romero, E. ; Mohamed, S. ; Stull, C. ; Oates, T. ; Tripathy, D. ; Alexander, P. ; Lasho, D. ; Gregory, H. ; Huynh-Ba, G. ; Jordan, J. ; Pena, S. ; Pacheco-Vera, C. ; Carrera, M. ; Munoz, A. ; Paquette, D. ; Engebretson, S. ; Gelato, M. ; Sayasith, T. ; Gu, Y. ; Roth, A. ; Urbankova, A. ; Ryan, M. ; Tuthill, J. ; Hughes, J. ; Grewal, S. ; Tenzler, R. ; Houshmand, B. ; Iacono, V. ; Katancik, J. ; Wang, B. ; Orlander, P. ; Eswaran, S. ; Parthasarathy, K. ; Weltman, R. ; Wehmeyer, M. ; Arastu, A. ; Thomas, R. ; Headley, J. ; Cavender, A. ; Harrison, N. J. ; Dancsak, T. ; Galpin, M. ; Ruscheinksy, M. ; Tsai, M. ; Hanson, N. ; Nowicki, M. ; Le, V. ; The DPTT study group. / 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. In: Contemporary Clinical Trials. 2013 ; Vol. 36, No. 2. pp. 515-526
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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 = "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 M. Kaur and A. Stevens and S. Goggin and L. Pitman and K. Trammel and C. Peterson and S. Haigh and J. Jackson and E. Finch and S. Akers and V. Grant and S. Acharya and S. McLean and J. Turman and J. Roche and C. Bragg and R. Rajanna and E. Bolton and B. Michalowicz and D. Diangelis and E. Seaquist and J. Danielson and P. Lenton and L. Wolff and P. Thibado and S. Molletti and L. Long-Simpson and Y. Okorocha and B. Hadfield and L. Bartels and C. Dunn and K. Meyer and K. Reibel and A. Jordan and R. Hedge and O. Herrera and E. Romero and S. Mohamed and C. Stull and T. Oates and D. Tripathy and P. Alexander and D. Lasho and H. Gregory and G. Huynh-Ba and J. Jordan and S. Pena and C. Pacheco-Vera and M. Carrera and A. Munoz and D. Paquette and S. Engebretson and M. Gelato and T. Sayasith and Y. Gu and A. Roth and A. Urbankova and M. Ryan and J. Tuthill and J. Hughes and S. Grewal and R. Tenzler and B. Houshmand and V. Iacono and J. Katancik and B. Wang and P. Orlander and S. Eswaran and K. Parthasarathy and R. Weltman and M. Wehmeyer and A. Arastu and R. Thomas and J. Headley and A. Cavender and Harrison, {N. J.} and T. Dancsak and M. Galpin and M. Ruscheinksy and M. Tsai and N. Hanson and M. Nowicki and V. Le and {The DPTT study group}",
year = "2013",
doi = "10.1016/j.cct.2013.09.010",
volume = "36",
pages = "515--526",
journal = "Contemporary Clinical Trials",
issn = "1551-7144",
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TY - JOUR

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

T2 - Contemporary Clinical Trials

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 - Kaur,M.

AU - Stevens,A.

AU - Goggin,S.

AU - Pitman,L.

AU - Trammel,K.

AU - Peterson,C.

AU - Haigh,S.

AU - Jackson,J.

AU - Finch,E.

AU - Akers,S.

AU - Grant,V.

AU - Acharya,S.

AU - McLean,S.

AU - Turman,J.

AU - Roche,J.

AU - Bragg,C.

AU - Rajanna,R.

AU - Bolton,E.

AU - Michalowicz,B.

AU - Diangelis,D.

AU - Seaquist,E.

AU - Danielson,J.

AU - Lenton,P.

AU - Wolff,L.

AU - Thibado,P.

AU - Molletti,S.

AU - Long-Simpson,L.

AU - Okorocha,Y.

AU - Hadfield,B.

AU - Bartels,L.

AU - Dunn,C.

AU - Meyer,K.

AU - Reibel,K.

AU - Jordan,A.

AU - Hedge,R.

AU - Herrera,O.

AU - Romero,E.

AU - Mohamed,S.

AU - Stull,C.

AU - Oates,T.

AU - Tripathy,D.

AU - Alexander,P.

AU - Lasho,D.

AU - Gregory,H.

AU - Huynh-Ba,G.

AU - Jordan,J.

AU - Pena,S.

AU - Pacheco-Vera,C.

AU - Carrera,M.

AU - Munoz,A.

AU - Paquette,D.

AU - Engebretson,S.

AU - Gelato,M.

AU - Sayasith,T.

AU - Gu,Y.

AU - Roth,A.

AU - Urbankova,A.

AU - Ryan,M.

AU - Tuthill,J.

AU - Hughes,J.

AU - Grewal,S.

AU - Tenzler,R.

AU - Houshmand,B.

AU - Iacono,V.

AU - Katancik,J.

AU - Wang,B.

AU - Orlander,P.

AU - Eswaran,S.

AU - Parthasarathy,K.

AU - Weltman,R.

AU - Wehmeyer,M.

AU - Arastu,A.

AU - Thomas,R.

AU - Headley,J.

AU - Cavender,A.

AU - Harrison,N. J.

AU - Dancsak,T.

AU - Galpin,M.

AU - Ruscheinksy,M.

AU - Tsai,M.

AU - Hanson,N.

AU - Nowicki,M.

AU - Le,V.

AU - The DPTT study group

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

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