Intimal Medial Thickness of Internal Carotid Artery, Periodontitis
Conditions
Brief summary
The investigators wish to assess whether intensive periodontal therapy will reduce the burden of chronic periodontal disease and will cause regression or prevent progression of atherosclerosis assessed by a surrogate end-point (carotid intima-media thickness) at 24 months compared to control periodontal therapy.
Interventions
PROCEDUREIntensive Periodontal Treatment
PROCEDUREControl Periodontal Treatment
Sponsors
University College, London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Participants must be ≥ 18 years-old. 2. Participants must have moderate to severe periodontitis (at least 30 periodontal pockets \> 4mm with Bleeding on Probing) and radiographic signs of bone loss. 3. Participants must have voluntarily signed the informed consent.
Exclusion criteria
1. Female participant is pregnant or lactating or of childbearing and not using acceptable methods of birth control. 2. Participant is on chronic treatment (i.e., two weeks or more) with specific medications known to affect periodontal status (phenytoin or cyclosporine) within one month of baseline visit. 3. Participant knowingly has HIV or Hepatitis. 4. Participant has limited mental capacity or language skills such that simple instructions cannot be followed or information regarding adverse events cannot be provided. 5. Participant on chronic antibiotic therapy or who require antibiotic coverage for periodontal procedures. 6. Participant had a course of periodontal therapy in the preceding 6 month
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Common Carotid Intima-media Thickness (cIMT) | cIMT will be assessed at Baseline, 12 and 24 months after periodontal treatment | Assess whether intensive periodontal therapy will cause regression or prevent progression of atherosclerosis assessed by carotid intima-media thickness at 24 months compared to standard periodontal therapy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood inflammatory markers | Inflammatory mediators profile will be assessed at baseline, 2, 6, 12, 18 and 24 months following periodontal treatment | Assess whether intensive periodontal therapy will cause changes in the blood inflammatory markers profile at 2, 6, 12, 18 and 24 months follow up compared to standard periodontal therapy. |
| Brachial artery Flow-mediated dilatation (FMD) | FMD will be assessed at baseline, 24 hours and 1 week after periodontal treatment | Assess whether pre-treatment (24hrs before) with remote ischaemic pre-conditioning will prevent acute inflammatory endothelial dysfunction induced by intensive periodontal treatment |
| Pulse-wave velocity (PWV) | PWV will be assessed at baseline, 2, 6, 12, 18 and 24 months following periodontal treatment | Assess whether intensive periodontal therapy will cause amelioration of PWV at 12, 18 and 24 months follow up compared to standard periodontal therapy. |
| Oxidative stress | Oxidative stress profile will be assessed at baseline, 2, 6, 12, 18 and 24 months following periodontal treatment | Assess whether intensive periodontal therapy will cause changes in the oxidative stress profile at 2, 6, 12, 18 and 24 months follow up compared to standard periodontal therapy. |
Countries
United Kingdom
Outcome results
None listed