Periodontitis Vascular Dysfunctio

Phase 2

Completed

Conditions: Topic: Oral and Gastrointestinal
Subtopic: Oral and Gastrointestinal (all Subtopics)
Disease: Oral & Dental
Digestive System
Periodontosis

Registration Number: ISRCTN39062047

Lead Sponsor: niversity College London (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 284

Inclusion Criteria

1. Subject must be > 18 years
2. Subject must have moderate to severe PD (at least 30 periodontal pockets >4mm with Bleeding on Probing)
3. Subject must have voluntarily signed the informed consent

Exclusion Criteria

1. Female subject is pregnant or lactating or of childbearing and not using acceptable methods of birth control
2. Subject 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. Subject knowingly has HIV or Hepatitis
4. Subject has limited mental capacity or language skills such that simple instructions cannot be followed or information regarding adverse events cannot be provided
5. Subjects on chronic antibiotic therapy or who require antibiotic coverage for periodontal procedures
6. Subjects had a course of periodontal therapy in the preceding 6 month

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measure as of 18/04/2017:<br>Common carotid intima media thickness (c-IMT) is measured using an ultrasound at baseline, 12 and 24 months.<br><br>Previous primary outcome measures:<br>C-IMT; Timepoint(s): 12 Months, 24 Months

Secondary Outcome Measures

Name	Time	Method
Current secondary outcome measures:<br>1. Brachial artery flow-mediated dilatation (FMD) is measured using a blood pressure cuff at baseline, 24 hours and 1 week after periodontal treatment.<br>2. Pulse-wave velocity is assessed at baseline, two, six, 12, 18 and 24 months after peridontal treatment<br>3. Blood inflammatory markers are measured using blood tests at baseline, two, six, 12, 18 and 24 months after peridontal treatment<br>4. Oxidative stressis assessed at baseline, two, six, 12, 18 and 24 months after peridontal treatment<br>5. Masticatory function is assessed at two time-points.<br><br>Previous secondary outcome meaures:<br>1. Biomarkers; Timepoint(s): Every 6 months for 24 months<br>2. Clinical Periodontal Measures; Timepoint(s): Every 12 months<br>3. FMD; Timepoint(s): Every 6 months up to 24 months<br>4. PVW; Timepoint(s): Every 6 months up to 24 months