Influence of successful periodontal intervention on renal disease
| ISRCTN | ISRCTN10227738 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10227738 |
| Secondary identifying numbers | 18458 |
- Submission date
- 22/04/2015
- Registration date
- 23/04/2015
- Last edited
- 07/03/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English Summary
Background and study aims
Patients with chronic kidney disease (CKD) may also have a common, bacterial inflammatory condition affecting the gums (periodontitis). The effects of periodontitis are not limited to the mouth but spread to other sites in the body via bleeding gums during eating, talking or brushing. Periodontitis is easily treatable using a mix of professional cleaning by a dentist or hygienist and improved homecare on the part of the patient. In an ongoing study being carried out in Birmingham, we have found that periodontitis might have a deleterious effect on the general health of patients with CKD. Given that periodontitis is readily treatable and that the treatment of periodontitis may have a beneficial effect on patients, the aim of this study is to test the practicality of conducting a larger-scale study to investigate the effect of treating periodontitis on the general health of patients with CKD.
Who can participate?
Patients aged 18 and over with periodontitis. To be included in group 1 (see below) the patients also have to have CKD.
What does the study involve?
Patients with CKD and periodontitis are randomly allocated into one of two groups. Those in group 1 receive intensive treatment for their periodontitis at the Birmingham Dental Hospital. The effects of this treatment on the general health of patients with CKD are assessed by comparing these patients to patients randomly assigned to the other group who receive this intensive treatment but after a delay of 12 months. All patients are followed up for 18 months.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
Birmingham Dental Hospital (UK)
When is the study starting and how long is it expected to run for?
January 2015 to April 2024
Who is funding the study?
1. Kidney Disease UK
2. National Institute for Health Research (UK)
Who is the main contact?
Mr Praveen Sharma
Contact information
Scientific
Birmingham Dental Hospital
St Chad's Queensway
Birmingham
B4 6NN
United Kingdom
 ORCID ID |
0000-0001-6435-4842 |
|---|
Study information
| Study design | Randomised; Interventional; Design type: Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Influence of successful periodontal intervention on renal and vascular systems in patients with chronic kidney disease: a pilot interventional randomised controlled trial |
| Study acronym | INSPIRED |
| Study hypothesis | The overarching research question which this pilot will contribute to answering is: In patients with Chronic Kidney Disease (CKD) and periodontitis, does the intensive treatment of periodontitis and maintenance of periodontal health, compared with the current, community-care standard of periodontal therapy, have an impact upon renal and cardiovascular health? |
| Ethics approval(s) | West Midlands – The Black Country Research Ethics Committee, 08/01/2015, ref: 15/WM/0006 |
| Condition | Topic: Oral and dental health, Renal disorders; Subtopic: Renal disorders, Oral and dental public health; Disease: All Oral and dental health, All Renal disorders |
| Intervention | Intensive periodontal treatment, oral hygiene instructions, supra and sub gingival scaling and non-surgical root surface debridement followed by periodontal maintenance therapy Study Entry : Registration and One or More Randomisations |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | As this is a pilot study, the primary objective will be informing a definitive trial to follow. The feasibility/pilot objectives include: 1. Investigating the integrity of the study protocol 2. Insight into likely recruitment rates and barriers to recruitment 3. Testing delivery of patient questionnaires and the randomisation process 4. Assessing the acceptability of the intervention 5. Collection of pilot data on effect size and variability 6. Selection of suitable primary and secondary outcomes (from the outcomes of interest listed below) and subsequent sample size calculation for a pivotal trial. The outcomes of interest include: 1. Measures of renal function 2. Measures of cardiovascular function 3. Measures of periodontal health 4. Patient-centred outcomes |
| Secondary outcome measures | No secondary outcome measures |
| Overall study start date | 01/01/2015 |
| Overall study end date | 30/04/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 140; UK Sample Size: 140 |
| Total final enrolment | 77 |
| Participant inclusion criteria | Inclusion criteria for all participants: 1. Patient aged ≥18 years and 2. Be able to provide consent to participate in the trial Additional inclusion criteria for patients with CKD and periodontitis: 1. Secondary care renal follow up for at least 1 year prior to recruitment 2. Decline of eGFR of 5mls/min/year or 10mls/min/5years 3. And/or an Albumin Creatinine Ratio (ACR )>70mmol/l on three occasions 4. And/or CKD 4 or 5 (pre-dialysis) 5. And generalised moderate-severe periodontitis defined as a minimum cumulative probing depth of 30mm (excluding probing depths <5mm) Additional inclusion criteria for systemically healthy patients with periodontitis: 1. Generalised moderate-severe periodontitis defined as a minimum cumulative probing depth of 30mm (excluding probing depths <5mm) |
| Participant exclusion criteria | Exclusion criteria for all participants: 1. Not meeting the inclusion criteria 2. Unable to provide informed consent Additional exclusion criteria for patients with CKD and periodontitis: 1. Requiring Renal Replacement Therapy (dialysis/transplant) 2. Immunosuppression 3. Received specialist periodontal treatment in the past 1 year 4. Not amenable to periodontal treatment e.g. severe bleeding disorders that contraindicate periodontal treatment Additional exclusion criteria for systemically healthy patients with periodontitis: 1. Any self-reported systemic illness eg hypertension or diabetes 2. Received specialist periodontal treatment in the past 1 year 3. Not amenable to periodontal treatment e.g. severe bleeding disorders that contraindicate periodontal treatment Additional exclusion criteria for systemically healthy patients without periodontitis: 1. Any self-reported systemic illness eg hypertension or diabetes 2. Periodontitis defined as probing depth of >4mm at any site |
| Recruitment start date | 26/02/2015 |
| Recruitment end date | 30/04/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
St Chad's Queensway
Birmingham
B4 6NN
United Kingdom
Sponsor information
University/education
Edgbaston
Birmingham
B4 6NN
England
United Kingdom
| Website | http://www.birmingham.ac.uk/ |
|---|---|
"ROR" |
https://ror.org/03angcq70 |
Funders
Funder type
Government
Private sector organisation / Other non-profit organizations
- Location
- United Kingdom
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/04/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Publication of the methodology in a peer reviewed journal. |
| IPD sharing plan | There are currently no plans to share pseudoanonymised IPD. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 13/11/2017 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
07/03/2023: The overall trial end date was changed from 30/04/2022 to 30/04/2024.
14/05/2021: The following changes have been made:
1. The overall trial end date has been changed from 01/04/2019 to 30/04/2022.
2. The final enrolment number has been added.
3. The intention to publish date has been changed from 01/12/2015 to 30/04/2024.
4. The IPD sharing statement has been added.
15/11/2017: Publication reference added.
02/08/2016: The recruitment end date has been updated from 30/04/2016 to 30/04/2018 and the overall trial end date has been updated from 01/04/2018 to 30/04/2019.
17/08/2015: The recruitment end date was changed from 26/10/2015 to 30/04/2016.
