INfluence of Successful Periodontal Intervention in Renal Disease (INSPIRED): study protocol for a randomised controlled pilot clinical trial

Research output: Contribution to journalArticlepeer-review

Standard

Harvard

APA

Vancouver

Author

Bibtex

@article{b3b904a88ab549ae8fca70776c330ba8,
title = "INfluence of Successful Periodontal Intervention in Renal Disease (INSPIRED): study protocol for a randomised controlled pilot clinical trial",
abstract = "BackgroundPatients with chronic kidney disease (CKD) exhibit increased morbidity and mortality which is associated with an increased systemic inflammatory burden. Identifying and managing co-morbid diseases that contribute to this load may inform novel care pathways that could have a beneficial impact on the morbidity/mortality associated with CKD. Periodontitis, a highly prevalent, chronic inflammatory disease affecting the supporting structures of teeth, is associated with an increased systemic inflammatory and oxidative stress burden and the successful treatment of periodontitis has been shown to reduce both.This pilot study aims to gather data to inform a definitive study into the impact of successful periodontal treatment on the cardio-renal health of patients with CKD.Methods / designThis pilot study will employ a randomised, controlled, parallel-group design. Sixty adult patients, with CKD with a high risk of progression and with periodontitis, from the Queen Elizabeth Hospital, Birmingham, will be randomised to receive either immediate, intensive periodontal treatment (n=30) or treatment at a delay of 12 months (n=30). Patients will be excluded if they have reached end stage renal disease or have received specialist periodontal treatment in the previous year. Periodontal treatment will be delivered under local anaesthetic, on an out-patient basis, over several visits by a qualified dental hygienist at the Birmingham Dental Hospital, UK. Patients in the delayed treatment arm will continue to receive the standard community level of periodontal care for a period of 12 months followed by the intensive periodontal treatment. Randomization will occur using a centralised telephone randomisation service, following baseline assessments. The assessor of periodontal health will be blinded to the patients{\textquoteright} treatment allocation. Patients in either arm will be followed up at 3-monthly intervals for 18 months. Aside from the pilot outcomes to inform the practicalities of a larger trial later, data on cardio-renal function, periodontal health and patient reported outcomes will be collected at each time point. Trial registrationThe trial is registered with the National Institute of Health Research (NIHR) Clinical Research Network (UKCRN ID:18458) and has the following ISRCTN identifier:ISRCTN10227738. Date of registration to both registers: 23 April 2015, retrospectively registered.",
keywords = "Periodontitis, Chronic Kidney Disease, randomised controlled trial, periodontal treatment, intervention, pilot study",
author = "Praveen Sharma and Paul Cockwell and Thomas Dietrich and Charles Ferro and Natalie Rowland and Iain Chapple",
year = "2017",
month = nov,
day = "13",
doi = "10.1186/s13063-017-2236-5",
language = "English",
volume = "18",
journal = "Trials",
issn = "1745-6215",
publisher = "Springer",

}

RIS

TY - JOUR

T1 - INfluence of Successful Periodontal Intervention in Renal Disease (INSPIRED)

T2 - study protocol for a randomised controlled pilot clinical trial

AU - Sharma, Praveen

AU - Cockwell, Paul

AU - Dietrich, Thomas

AU - Ferro, Charles

AU - Rowland, Natalie

AU - Chapple, Iain

PY - 2017/11/13

Y1 - 2017/11/13

N2 - BackgroundPatients with chronic kidney disease (CKD) exhibit increased morbidity and mortality which is associated with an increased systemic inflammatory burden. Identifying and managing co-morbid diseases that contribute to this load may inform novel care pathways that could have a beneficial impact on the morbidity/mortality associated with CKD. Periodontitis, a highly prevalent, chronic inflammatory disease affecting the supporting structures of teeth, is associated with an increased systemic inflammatory and oxidative stress burden and the successful treatment of periodontitis has been shown to reduce both.This pilot study aims to gather data to inform a definitive study into the impact of successful periodontal treatment on the cardio-renal health of patients with CKD.Methods / designThis pilot study will employ a randomised, controlled, parallel-group design. Sixty adult patients, with CKD with a high risk of progression and with periodontitis, from the Queen Elizabeth Hospital, Birmingham, will be randomised to receive either immediate, intensive periodontal treatment (n=30) or treatment at a delay of 12 months (n=30). Patients will be excluded if they have reached end stage renal disease or have received specialist periodontal treatment in the previous year. Periodontal treatment will be delivered under local anaesthetic, on an out-patient basis, over several visits by a qualified dental hygienist at the Birmingham Dental Hospital, UK. Patients in the delayed treatment arm will continue to receive the standard community level of periodontal care for a period of 12 months followed by the intensive periodontal treatment. Randomization will occur using a centralised telephone randomisation service, following baseline assessments. The assessor of periodontal health will be blinded to the patients’ treatment allocation. Patients in either arm will be followed up at 3-monthly intervals for 18 months. Aside from the pilot outcomes to inform the practicalities of a larger trial later, data on cardio-renal function, periodontal health and patient reported outcomes will be collected at each time point. Trial registrationThe trial is registered with the National Institute of Health Research (NIHR) Clinical Research Network (UKCRN ID:18458) and has the following ISRCTN identifier:ISRCTN10227738. Date of registration to both registers: 23 April 2015, retrospectively registered.

AB - BackgroundPatients with chronic kidney disease (CKD) exhibit increased morbidity and mortality which is associated with an increased systemic inflammatory burden. Identifying and managing co-morbid diseases that contribute to this load may inform novel care pathways that could have a beneficial impact on the morbidity/mortality associated with CKD. Periodontitis, a highly prevalent, chronic inflammatory disease affecting the supporting structures of teeth, is associated with an increased systemic inflammatory and oxidative stress burden and the successful treatment of periodontitis has been shown to reduce both.This pilot study aims to gather data to inform a definitive study into the impact of successful periodontal treatment on the cardio-renal health of patients with CKD.Methods / designThis pilot study will employ a randomised, controlled, parallel-group design. Sixty adult patients, with CKD with a high risk of progression and with periodontitis, from the Queen Elizabeth Hospital, Birmingham, will be randomised to receive either immediate, intensive periodontal treatment (n=30) or treatment at a delay of 12 months (n=30). Patients will be excluded if they have reached end stage renal disease or have received specialist periodontal treatment in the previous year. Periodontal treatment will be delivered under local anaesthetic, on an out-patient basis, over several visits by a qualified dental hygienist at the Birmingham Dental Hospital, UK. Patients in the delayed treatment arm will continue to receive the standard community level of periodontal care for a period of 12 months followed by the intensive periodontal treatment. Randomization will occur using a centralised telephone randomisation service, following baseline assessments. The assessor of periodontal health will be blinded to the patients’ treatment allocation. Patients in either arm will be followed up at 3-monthly intervals for 18 months. Aside from the pilot outcomes to inform the practicalities of a larger trial later, data on cardio-renal function, periodontal health and patient reported outcomes will be collected at each time point. Trial registrationThe trial is registered with the National Institute of Health Research (NIHR) Clinical Research Network (UKCRN ID:18458) and has the following ISRCTN identifier:ISRCTN10227738. Date of registration to both registers: 23 April 2015, retrospectively registered.

KW - Periodontitis

KW - Chronic Kidney Disease

KW - randomised controlled trial

KW - periodontal treatment

KW - intervention

KW - pilot study

U2 - 10.1186/s13063-017-2236-5

DO - 10.1186/s13063-017-2236-5

M3 - Article

VL - 18

JO - Trials

JF - Trials

SN - 1745-6215

M1 - 535

ER -