Influence of successful periodontal intervention on renal disease

Not Applicable

• Conditions: Topic: Oral and dental health, Renal disorders; Subtopic: Renal disorders, Oral and dental public health; Disease: All Oral and dental health, All Renal disorders; Oral Health

• Registration Number: ISRCTN10227738
• Lead Sponsor: niversity of Birmingham

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-23
• Last Update Posted: 20 March 2023
• Study Completion: 2024-04-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 77

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)

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> As this is a pilot study, the primary objective will be informing a definitive trial to follow. The feasibility/pilot objectives include:<br> 1. Investigating the integrity of the study protocol<br> 2. Insight into likely recruitment rates and barriers to recruitment<br> 3. Testing delivery of patient questionnaires and the randomisation process<br> 4. Assessing the acceptability of the intervention<br> 5. Collection of pilot data on effect size and variability<br> 6. Selection of suitable primary and secondary outcomes (from the outcomes of interest listed below) and subsequent sample size calculation for a pivotal trial.<br> The outcomes of interest include:<br> 1. Measures of renal function<br> 2. Measures of cardiovascular function<br> 3. Measures of periodontal health<br> 4. Patient-centred outcomes<br>

Secondary Outcome Measures

Name	Time	Method
o secondary outcome measures