Condition category
Oral Health
Date applied
22/04/2015
Date assigned
23/04/2015
Last edited
15/11/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 is 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?
February 2015 to August 2015

Who is funding the study?
1. Kidney Disease UK
2. National Institute for Health Research (UK)

Who is the main contact?
Mr Praveen Sharrma

Trial website

Contact information

Type

Scientific

Primary contact

Mr Praveen Sharrma

ORCID ID

http://orcid.org/0000-0001-6435-4842

Contact details

Birmingham Dental Hospital
St Chad's Queensway
Birmingham
B4 6NN
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

18458

Study information

Scientific title

Influence of successful periodontal intervention on renal and vascular systems in patients with chronic kidney disease: a pilot interventional randomised controlled trial

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

West Midlands – The Black Country Research Ethics Committee, 08/01/2015, ref: 15/WM/0006

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a participant information sheet

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/01/2015

Overall trial end date

01/04/2019

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 140; UK Sample Size: 140

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

United Kingdom

Trial participating centre

Birmingham Dental Hospital
School Of Dentistry St Chad's Queensway
Birmingham
B4 6NN
United Kingdom

Sponsor information

Organisation

University of Birmingham

Sponsor details

Edgbaston
Birmingham
B4 6NN
United Kingdom

Sponsor type

University/education

Website

http://www.birmingham.ac.uk/

Funders

Funder type

Government

Funder name

Kidney Research UK

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Publication of the methodology in a peer reviewed journal.

Intention to publish date

01/12/2015

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/29132440

Publication citations

Additional files

Editorial Notes

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.