PERIODONTITIS AND VASCULAR DYSFUNCTION

Periodontitis Clinical Trial

Official title:

INTENSIVE TREATMENT FOR PERIODONTAL DISEASE: A MODEL OF AND THERAPY OF INFLAMMATORY VASCULAR DYSFUNCTION

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03072342
• Other study ID #: 13/0044
• Status: Completed
• Phase: N/A
• Start date: April 16, 2013
• Est. completion date: March 30, 2020

Study information

• Verified date: February 2020
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 190
• Est. completion date: March 30, 2020
• Est. primary completion date: March 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intimal Medial Thickness of Internal Carotid Artery
• Periodontitis

Intervention

Procedure:
• Intensive Periodontal Treatment

• Control Periodontal Treatment

Locations

Country	Name	City	State
United Kingdom	UCL-Eastman Dental Institute	London

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Common Carotid Intima-media Thickness (cIMT)	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.	cIMT will be assessed at Baseline, 12 and 24 months after periodontal treatment
Secondary	Brachial artery Flow-mediated dilatation (FMD)	Assess whether pre-treatment (24hrs before) with remote ischaemic pre-conditioning will prevent acute inflammatory endothelial dysfunction induced by intensive periodontal treatment	FMD will be assessed at baseline, 24 hours and 1 week after periodontal treatment
Secondary	Pulse-wave velocity (PWV)	Assess whether intensive periodontal therapy will cause amelioration of PWV at 12, 18 and 24 months follow up compared to standard periodontal therapy.	PWV will be assessed at baseline, 2, 6, 12, 18 and 24 months following periodontal treatment
Secondary	Brachial artery Flow-mediated dilatation (FMD)	Assess whether intensive periodontal therapy will cause amelioration of FMD at 12, 18 and 24 months follow up compared to standard periodontal therapy.	FMD will be assessed at baseline, 2 , 6 , 12 , 18 and 24 months following periodontal treatment
Secondary	Blood inflammatory markers	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.	Inflammatory mediators profile will be assessed at baseline, 2, 6, 12, 18 and 24 months following periodontal treatment
Secondary	Oxidative stress	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.	Oxidative stress profile will be assessed at baseline, 2, 6, 12, 18 and 24 months following periodontal treatment