Topic: Oral and dental health, Renal disorders
Conditions
Interventions
Intensive periodontal treatment, oral hygiene instructions, supra and sub gingival scaling and non-surgical root surface debridement followed by periodontal maintenance therapy
Study E
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
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: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
England, United Kingdom
Outcome results
None listed