Dataset Information

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 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.

SUBMITTER: DPTT study group

PROVIDER: S-EPMC3885354 | biostudies-literature | 2013 Nov

REPOSITORIES: biostudies-literature

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Publications

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 S Gelato M M Hyman L L Michalowicz B S BS Schoenfeld E E

Contemporary clinical trials 20130927 2

<h4>Background</h4>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.<h4>Purpose</h4>The purpose of the Diabetes and Periodontal Therapy Trial (DPTT) was to determine if periodontal ...[more]

PMID: 24080100

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Project description:ImportanceChronic periodontitis, a destructive inflammatory disorder of the supporting structures of the teeth, is prevalent in patients with diabetes. Limited evidence suggests that periodontal therapy may improve glycemic control.ObjectiveTo determine if nonsurgical periodontal treatment reduces levels of glycated hemoglobin (HbA1c) in persons with type 2 diabetes and moderate to advanced chronic periodontitis.Design, setting, and participantsThe Diabetes and Periodontal Therapy Trial (DPTT), a 6-month, single-masked, multicenter, randomized clinical trial. Participants had type 2 diabetes, were taking stable doses of medications, had HbA1c levels between 7% and less than 9%, and untreated chronic periodontitis. Five hundred fourteen participants were enrolled between November 2009 and March 2012 from diabetes and dental clinics and communities affiliated with 5 academic medical centers.InterventionsThe treatment group (n = 257) received scaling and root planing plus chlorhexidine oral rinse at baseline and supportive periodontal therapy at 3 and 6 months. The control group (n = 257) received no treatment for 6 months.Main outcomes and measuresDifference in change in HbA1c level from baseline between groups at 6 months. Secondary outcomes included changes in probing pocket depths, clinical attachment loss, bleeding on probing, gingival index, fasting glucose level, and Homeostasis Model Assessment (HOMA2) score.ResultsEnrollment was stopped early because of futility. At 6 months, mean HbA1c levels in the periodontal therapy group increased 0.17% (SD, 1.0), compared with 0.11% (SD, 1.0) in the control group, with no significant difference between groups based on a linear regression model adjusting for clinical site (mean difference, -0.05% [95% CI, -0.23% to 0.12%]; P = .55). Periodontal measures improved in the treatment group compared with the control group at 6 months, with adjusted between-group differences of 0.28 mm (95% CI, 0.18 to 0.37) for probing depth, 0.25 mm (95% CI, 0.14 to 0.36) for clinical attachment loss, 13.1% (95% CI, 8.1% to 18.1%) for bleeding on probing, and 0.27 (95% CI, 0.17 to 0.37) for gingival index (P < .001 for all).Conclusions and relevanceNonsurgical periodontal therapy did not improve glycemic control in patients with type 2 diabetes and moderate to advanced chronic periodontitis. These findings do not support the use of nonsurgical periodontal treatment in patients with diabetes for the purpose of lowering levels of HbA1c.Trial registrationclinicaltrials.gov Identifier: NCT00997178.

Project description:Background40 subjects with type 2 diabetes and moderate to severe CP were randomly distributed to groups receiving either NSPT or OHI. Periodontal parameters, glycosylated haemoglobin (HbA1c) and high-sensitivity C-reactive protein (hs-CRP) were evaluated at baseline, 2- and 3-months intervals.Methods40 subjects with type 2 diabetes and moderate to severe CP were randomly distributed to groups receiving either NSPT or OHI. Periodontal parameters, glycosylated haemoglobin (HbA1c) and high-sensitivity C-reactive protein (hs-CRP) were evaluated at baseline, 2- and 3-months intervals.Results15 subjects from NSPT group and 17 from OHI group completed the study. The difference in plaque index (PI) between NSPT and OHI groups were significant at 2 months recall (p = 0.013). There was no significant difference between NSPT and OHI group for all other clinical periodontal parameters, HbA1c and CRP levels. At 3 months post-therapy, periodontal parameters improved significantly in both groups with sites with probing pocket depth (PPD) < 4 mm reported as 98 ± 1.8% in NSPT group and 92 ± 14.9% in OHI group. Mean PPD and mean probing attachment loss (PAL) within the NSPT group reduced significantly from baseline (2.56 ± 0.57 mm, 3.35 ± 0.83 mm) to final visit (1.94 ± 0.26 mm, 2.92 ± 0.72 mm) (p = 0.003, p < 0.001). For OHI group, improvements in mean PPD and mean PAL were also seen from baseline (2.29 ± 0.69 mm, 2.79 ± 0.96 mm) to final visit (2.09 ± 0.72 mm, 2.62 ± 0.97 mm) (p < 0.001 for both). Similarly, HbA1c levels decreased in both groups with NSPT group recording statistically significant reduction (p = 0.038). Participants who demonstrated ≥ 50% reduction in PPD showed significant reductions of HbA1c and hs-CRP levels (p = 0.004 and p = 0.012).ConclusionNSPT significantly reduced PI at 2 months post-therapy as compared to OHI. Both NSPT and OHI demonstrated improvements in other clinical parameters as well as HbA1c and CRP levels.Trial registrationClinicalTrials.gov: NCT01951547.

Project description:Rationale & objectiveObservational studies have suggested that periodontal disease may be a modifiable risk factor for chronic kidney disease (CKD). The Kidney and Periodontal Disease (KAPD) Study was designed to determine the feasibility of conducting a periodontal disease treatment trial among a high-risk (mostly poor and racial/ethnic minority) population and estimate the magnitude and variability of kidney and inflammatory biomarker levels in response to intensive periodontal treatment.Study designSingle-center, unmasked, intention-to-treat, randomized, controlled, pilot trial with 2:1 allocation to the treatment and comparison groups.Setting & participantsEnglish- and Spanish-speaking individuals aged 20 to 75 years receiving primary care within the San Francisco Community Health Network with evidence of both moderate to severe periodontal disease and CKD.InterventionImmediate intensive nonsurgical periodontal treatment versus rescue treatment for progressive disease at baseline and 4, 8, and 12 months.OutcomesFeasibility and process outcomes. Levels of biomarkers of kidney function, kidney injury, and systemic inflammation obtained at baseline and 4 and 12 months.ResultsKAPD randomly assigned 51 participants to the immediate (34 participants) or rescue (17 participants) groups. 14% dropped out of the study (4 immediate, 3 rescue) and 80% completed all 4 visits of the 12-month protocol (28 immediate, 13 rescue). Fewer than half the teeth recommended for extraction were extracted and 40% of immediate group visits were outside the protocol window. Bleeding on probing and probing depth improved more in the immediate group than in the rescue group; there was no significant separation in periodontal status. Levels of markers of vascular endothelial and systemic injury declined in both groups.LimitationsNo true control group.ConclusionsThis 12-month, pilot, randomized, controlled trial successfully recruited and retained a high-risk population but was less successful observing treatment adherence, treatment effect, and variability of biomarker levels. Although KAPD did not meet all of its goals, important lessons learned can be applied to future studies.FundingNational Institute of Diabetes and Digestive and Kidney Disease (Bethesda, MD; grant number 1K23DK093710-01A1) and Harold Amos Medical Faculty Development Program of the Robert Wood Johnson Foundation, Princeton, NJ. Funders had no role in study design; collection, analysis, or interpretation of data; writing the report; or the decision to submit the report for publication.Trial registrationNCT01802216.

Dataset Information

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.

Background

Purpose

Methods

Conclusion

Publications

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.

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