PERIODONTITIS AND VASCULAR DYSFUNCTION

Not Applicable

Completed

• Conditions: Periodontitis; Intimal Medial Thickness of Internal Carotid Artery
• Interventions: Procedure: Control Periodontal Treatment; Procedure: Intensive Periodontal Treatment

• Registration Number: NCT03072342
• Lead Sponsor: University College, London

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-16
• Study First Submitted: 2017-03-01
• Study First Submitted QC: 2017-03-01
• Study First Posted: 2017-03-07
• Status Verified: 2020-02
• Primary Completion: 2020-03-30
• Study Completion: 2020-03-30
• Last Update Submitted: 2021-01-22
• Last Update Posted: 2021-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 190

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Periodontal Treatment (CPT)	Control Periodontal Treatment	-
Intensive Periodontal Treatment (IPT)	Intensive Periodontal Treatment	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Brachial artery Flow-mediated dilatation (FMD)	FMD will be assessed at baseline, 2 , 6 , 12 , 18 and 24 months following periodontal treatment	Assess whether intensive periodontal therapy will cause amelioration of FMD at 12, 18 and 24 months follow up compared to standard periodontal therapy.
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.
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.
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.

Trial Locations

Locations (1)

UCL-Eastman Dental Institute; 🇬🇧 London, United Kingdom