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Nonsurgical Periodontal Therapy in CKD: Findings of the Kidney and Periodontal Disease (KAPD) Pilot Randomized Controlled Trial.

ABSTRACT: Rationale & Objective:Observational 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 Design:Single-center, unmasked, intention-to-treat, randomized, controlled, pilot trial with 2:1 allocation to the treatment and comparison groups. Setting & Participants:English- 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. Intervention:Immediate intensive nonsurgical periodontal treatment versus rescue treatment for progressive disease at baseline and 4, 8, and 12 months. Outcomes:Feasibility and process outcomes. Levels of biomarkers of kidney function, kidney injury, and systemic inflammation obtained at baseline and 4 and 12 months. Results:KAPD 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. Limitations:No true control group. Conclusions:This 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. Funding:National 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 Registration:NCT01802216.

SUBMITTER: Grubbs V

PROVIDER: S-EPMC7380373 | biostudies-literature | 2020 Jan-Feb

REPOSITORIES: biostudies-literature

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Nonsurgical Periodontal Therapy in CKD: Findings of the Kidney and Periodontal Disease (KAPD) Pilot Randomized Controlled Trial.

Grubbs Vanessa V Garcia Faviola F Vittinghoff Eric E Jue Bonnie L BL Ryder Mark M Lovett David H DH Offenbacher Steven S Taylor George G Ganz Peter P Bibbins-Domingo Kirsten K Powe Neil R NR

Kidney medicine 20191202 1

<h4>Rationale & objective</h4>Observational 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 treatm ...[more]

PMID: 32734226

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Project description:Background and objectivesWe tested the feasibility of reducing sedentary behavior common in CKD.Design, setting, participants, & measurementsWe carried out a Sit Less, Interact, Move More intervention in a 24-week parallel-group, randomized controlled trial in patients with stages 2-5 CKD. In the intervention group (n=54), accelerometry performed at baseline and repeated every 4 weeks was used to develop and monitor adherence to individualized plans targeting sedentary and stepping durations. The control group (n=52) was provided national physical activity recommendations; accelerometry was performed at baseline and every 8 weeks. Between-groups changes from baseline to the average follow-up values at weeks 8, 16, and 24 of the sedentary and stepping durations were the coprimary end points.ResultsThe mean age was 69±13 years. Fourteen percent were on dialysis or received a kidney transplant. Eight percent of the control group and 17% of the intervention group were lost to follow-up. Sedentary and stepping durations did not change in the control group. Within the intervention group, the maximum decrease in sedentary duration (-43; 95% confidence interval, -69 to -17 min/d) and increase in stepping duration (16; 95% confidence interval, 7 to 24 min/d) and the number of steps per day (1265; 95% confidence interval, 518 to 2012) were seen at week 20. These attenuated at week 24. In mixed effects models, overall treatment effects between groups on sedentary (-17; 95% confidence interval, -43 to 8 min/d) and stepping (6; 95% confidence interval, -3 to 15 min/d) durations and the number of steps per day, a secondary end point (652; 95% confidence interval, -146 to 1449), were not significantly different. The intervention significantly reduced secondary end points of body mass index (-1.1; 95% confidence interval, -1.9 to -0.3 kg/m2) and body fat percentage (-2.1%; 95% confidence interval, -4.4% to -0.2%).ConclusionsIt is feasible to reduce sedentary duration and increase stepping duration in patients with CKD, but these were not sustained.Clinical trial registry name and registration numberNational Health and Nutrition Examination Survey (NHANES), NCT02970123.

Project description:BackgroundHallux valgus is a common and disabling condition. This randomised pilot and feasibility trial aimed to determine the feasibility of conducting a parallel group randomised trial to evaluate the effectiveness of a nonsurgical intervention for reducing pain associated with hallux valgus.MethodsTwenty-eight community-dwelling women with painful hallux valgus were randomised to receive either a multifaceted, nonsurgical intervention (footwear, foot orthoses, foot exercises, advice, and self-management) or usual care (advice and self-management alone). Outcome measures were obtained at baseline, 4, 8 and 12 weeks. The primary outcome was feasibility, evaluated according to demand (recruitment rate and conversion rate), acceptability, adherence, adverse events, and retention rate. Limited efficacy testing was conducted on secondary outcome measures including foot pain, foot muscle strength, general health-related quality of life, use of cointerventions, and participants' perception of overall treatment effect.ResultsBetween July 8, 2021, and April 22, 2022, we recruited and tested 28 participants (aged 44 to 80 years, mean 60.7, standard deviation 10.7). This period encompassed two COVID-related stay-at-home orders (July 16 to July 27, and August 5 to October 21, 2021). The predetermined feasibility thresholds were met for retention rate, foot pain, mental health-related quality of life, and use of cointerventions, partly met for acceptability, adverse events, and muscle strength, and not met for demand (recruitment rate or conversion rate), adherence, physical health-related quality of life and perception of overall treatment effect.ConclusionIn its current form, a randomised trial of footwear, foot orthoses, foot exercises, advice and self-management for relieving pain associated with hallux valgus is not feasible, particularly due to the low adherence with the intervention. However, it is difficult to determine whether the trial would be feasible under different circumstances, particularly due to COVID-19 stay-at-home orders. Future trials will need to consider improving the aesthetics of the footwear and making the exercise program less burdensome.Trial registrationAustralian and New Zealand Clinical Trial Registry (ACTRN12621000645853).

Project description:BackgroundChronic kidney disease is associated with increased arterial stiffness even in the early stages and this is thought to be a key mediator in the pathophysiology of the increased cardiovascular risk associated with this condition. The use of low-dose spironolactone has previously been shown to improve arterial stiffness and reduce left ventricular mass safely in early-stage chronic kidney disease in the context of careful monitoring at a university hospital. However, the majority of patients with chronic kidney disease are managed by their general practitioners in the community. It is not known whether similar beneficial effects can be achieved safely using spironolactone in the primary care setting. The aim of this study is to determine whether low-dose spironolactone can safely lower arterial stiffness in patients with stage 3 chronic kidney disease in the primary care setting.Methods/designSTOP-CKD is a multicentre, prospective, randomized, double-blind, placebo-controlled pilot trial of 240 adult patients with stage 3 chronic kidney disease recruited from up to 20 general practices in South Birmingham, England. Participants will be randomly allocated using a secured web-based computer randomization system to receive either spironolactone 25 mg once daily or a matching inactive placebo for 40 weeks, followed by a wash-out period of 6 weeks. Investigators, outcome assessors, data analysts and participants will all be blinded to the treatment allocation. The primary endpoint is improved arterial stiffness, as measured by carotid-femoral pulse wave velocity between baseline and 40 weeks. The secondary endpoints are incidence of hyperkalaemia, change in estimated glomerular filtration rate, change in urine albumin:creatinine ratio, change in brachial blood pressure, change in pulse waveform characteristics and overall tolerability of spironolactone. An additional quality control study, aiming to compare the laboratory serum potassium results of samples processed via two methods (utilizing routine transport or centrifugation on site before rapid transport to the laboratory) for 100 participants and a qualitative research study exploring patients' and general practitioners' attitudes to research and the use of spironolactone in chronic kidney disease in the community setting will be embedded in this pilot study.Trial registrationCurrent Controlled Trials ISRCTN80658312.

Project description:Rationale & objectiveSustainable interventions that enhance chronic kidney disease (CKD) management are not often studied in safety-net primary care, in which populations bear a disproportionate burden of disease and experience translational gaps between research and practice. We tested the feasibility of implementing and the impact of 2 technology-enhanced interventions designed to enhance CKD care delivery.Study designA 2×2 randomized controlled pilot trial.Setting & participantsPrimary care provider teams (n = 6) and 137 patients with CKD aged 18 to 75 years from 2 safety-net primary care clinics, 2013 to 2015.InterventionsPrimary care provider teams were randomly assigned to access a CKD registry with point-of-care notifications and quarterly feedback or a usual-care registry for 12 months. Patients within provider teams were randomly assigned to participate in a CKD self-management support program or usual care for 12 months.OutcomesWe examined recruitment, randomization, and participation in each intervention. We also examined the impact of each intervention and their combination on change in systolic blood pressure (SBP), albuminuria, and patient self-reported behavioral measures after 12 months.ResultsAmong potentially eligible patients identified using the electronic health record, 24% were eligible for study participation, of whom 35% (n = 137) were enrolled. Mean age was 55 years, 41% were non-English speaking, and 93% were of racial/ethnic minority. Mean baseline estimated glomerular filtration rate was 70.5 (SD = 30.3) mL/min/1.73 m2; mean baseline SBP was 131 (SD = 21.8) mm Hg. Nearly 90% of clinicians reported that the CKD registry influenced their CKD management. More than 95% of patients randomly assigned to CKD self-management support engaged regularly with the intervention. Estimated changes in SBP over 1 year were nonstatistically different in each of the 3 intervention groups compared with usual care: (usual care: 0.5 [95% CI, -5.2 to 6.3] mm Hg; CKD registry only: -5.4 [95% CI, -12.2 to 1.4] mm Hg; CKD self-management support only: -6.4 [95% CI, -13.7 to 1.0] mm Hg; and CKD registry plus CKD self-management support: -0.5 [-5.5 to 4.5] mm Hg), though differences were larger among those with baseline SBPs > 140/90 mm Hg. Decreases in albuminuria were similarly nonstatistically different in each of the intervention groups compared with usual care. No differences were observed in patient self-reported behaviors.LimitationsSingle health system.ConclusionsPatient and provider interventions to improve CKD care are feasible to implement in low-income settings with promising results among those with uncontrolled blood pressure.FundingNational Institute of Diabetes and Digestive and Kidney Diseases.Trial registrationClinicalTrials.gov, number: NCT01530958.

Project description:BackgroundThe mechanical disruption and removal of the subgingival biofilm represent the most important step in the treatment of periodontitis. However, in deep periodontal pockets, mechanical removal of the subgingival biofilm is difficult and frequently incomplete. Preliminary findings indicate that the use of amino acid buffered sodium hypochlorite (NaOCl) gel may chemically destroy the bacterial biofilm and facilitate its mechanical removal.ObjectivesTo clinically evaluate the efficacy of minimally invasive nonsurgical therapy (MINST) of periodontal pockets with or without local application of an amino acid buffered sodium hypochlorite (NaOCl) gel.Materials and methodsForty untreated patients diagnosed with severe/advanced periodontitis (i.e. stage III/IV) with a slow/moderate rate of progression (i.e. grade A/B) were randomly allocated in two treatment groups. In the test group, the periodontal pockets were treated by means of MINST and NaOCl gel application, while in the control group, treatment consisted of MINST alone. Full-mouth plaque scores (FMPS), full-mouth bleeding scores (FMBS), probing depths (PD), clinical attachment levels (CAL) and gingival recessions (GR) were assessed at baseline and at 6 months following therapy. The primary outcome variable was PD reduction at sites with PD ≥ 5 mm at baseline.ResultsAt 6 months, statistically significant differences between the two groups were found (p = 0.001) in terms of PD and CAL change. No statistically significant differences were found in terms of GR (p = 0.81). The number of sites with PD ≥ 5 mm and BOP (+) decreased statistically significantly (p = 0.001), i.e. from 85.3 to 2.2% in the test group and from 81.6 to 7.3% in the control group, respectively. Statistically significant differences between test and control groups were recorded at 6 months (p = 0.001). MINST + NaOCl compared to MINST alone decreased statistically significantly (p = 0.001) the probability of residual PDs ≥ 5 mm with BOP- (14.5% vs 18.3%) and BOP+ (2.2% vs. 7.2%).ConclusionsWithin their limits, the present results indicate that (a) the use of MINST may represent a clinically valuable approach for nonsurgical therapy and (b) the application of NaOCl gel in conjunction with MINST may additionally improve the clinical outcomes compared to the use of MINST alone.Clinical relevanceIn patients with untreated periodontitis, treatment of deep pockets by means of MINST in conjunction with a NaOCl gel may represent a valuable approach to additionally improve the clinical outcomes obtained with MINST alone.

Project description:Few randomized controlled trials (RCTs) report interventions targeting improvement of frailty status as an outcome.This RCT enrolled 117 older adults (65-79?years of age) in Toufen, Taiwan who scored 3-6 on The Chinese Canadian Study of Health and Aging Clinical Frailty Scale Telephone Version and then score ?1 on the Cardiovascular Health Study Phenotypic Classification of Frailty (CHS_PCF). With a two by two factorial design, subjects were randomly assigned to interventions (Exercise and nutrition, EN, n?=?55 or problem solving therapy, PST, n?=?57) or controls (non-EN, n?=?62 or non-PST, n?=?60). Educational booklets were provided to all. EN group subjects received nutrition consultation and a thrice-weekly exercise-training program while PST group subjects received 6 sessions in 3?month. Subjects were followed at 3, 6, and 12?months. Primary outcome was improvement of the CHS_PCF by at least one category (from pre-frail to robust, or from frail to pre-frail or robust) from baseline assessments. One hundred and one completed final assessments. Intention-to-treat analysis with the generalized estimating equation model was applied with adjustment for time and treatment-by-time interactions.Mean age was 71.4?±?3.7?years, with 59% females. Baseline characteristic were generally comparable between groups. EN group subjects had a higher improvement rate on the primary outcome than non-EN group subjects (45% vs 27%, adjusted p?=?0.008) at 3?months, but not 6 or 12?months. They also had more increase of serum 25(OH) vitamin D level (4.9?±?7.7 vs 1.2?±?5.4, p?=?0.006) and lower percentage of osteopenia (74% vs 89% p?=?0.042) at 12?months. PST group subjects had better improvement (2.7?±?6.1 vs 0.2?±?6.7, p?=?0.035, 6-month) and less deterioration (-3.5?±?9.7 vs -7.1?±?8.7, p?=?0.036, 12-month) of dominant leg extension power than non-PST subjects. Some secondary outcomes were also improved in control groups (non-EN or non-PST). No adverse effects were reported.The three-month EN intervention resulted in short-term (3-month) frailty status improvement and long-term effect on bone mineral density and serum vitamin D (12-month) among Taiwanese community-dwelling elders. The effect of PST was less pronounced.ClinicalTrials.gov: EC0970301

Dataset Information

Nonsurgical Periodontal Therapy in CKD: Findings of the Kidney and Periodontal Disease (KAPD) Pilot Randomized Controlled Trial.

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Nonsurgical Periodontal Therapy in CKD: Findings of the Kidney and Periodontal Disease (KAPD) Pilot Randomized Controlled Trial.

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