PeriodontitisNCT03072342
PERIODONTITIS AND VASCULAR DYSFUNCTION
A study testing Intensive Periodontal Treatment in people with Periodontitis and Intimal Medial Thickness of Internal Carotid Artery, run by University College, London at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Periodontitis, Intimal Medial Thickness of Internal Carotid Artery
- What is being tested?
- Intensive Periodontal Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 190 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Apr 2013to 30 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be ≥ 18 years-old.
- Participants must have moderate to severe periodontitis (at least 30 periodontal pockets > 4mm with Bleeding on Probing) and radiographic signs of bone loss.
- Participants must have voluntarily signed the informed consent.
Who cannot join
- Female participant is pregnant or lactating or of childbearing and not using acceptable methods of birth control.
- 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.
- Participant knowingly has HIV or Hepatitis.
- Participant has limited mental capacity or language skills such that simple instructions cannot be followed or information regarding adverse events cannot be provided.
- Participant on chronic antibiotic therapy or who require antibiotic coverage for periodontal procedures.
- Participant had a course of periodontal therapy in the preceding 6 month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: INTENSIVE TREATMENT FOR PERIODONTAL DISEASE: A MODEL OF AND THERAPY OF INFLAMMATORY VASCULAR DYSFUNCTION
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.
- Being tested
- Intensive Periodontal Treatment, Control Periodontal Treatment
- Medical subject headings
- Periodontitis, Carotid Intimal Medial Thickness 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Periodontal TreatmentProcedure or surgery
Control Periodontal TreatmentProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Intensive Periodontal Treatment (IPT) | Active comparator | Not described Receives: Procedure: Intensive Periodontal Treatment |
| Control Periodontal Treatment (CPT) | Placebo comparator | Not described Receives: Procedure: Control Periodontal Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: cIMT will be assessed at Baseline, 12 and 24 months after periodontal treatment
Secondary outcomes (5)
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
Measured: FMD will be assessed at baseline, 24 hours and 1 week after periodontal treatment
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.
Measured: PWV will be assessed at baseline, 2, 6, 12, 18 and 24 months following periodontal treatment
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.
Measured: FMD will be assessed at baseline, 2 , 6 , 12 , 18 and 24 months following periodontal treatment
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.
Measured: Inflammatory mediators profile will be assessed at baseline, 2, 6, 12, 18 and 24 months following periodontal treatment
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.
Measured: Oxidative stress profile will be assessed at baseline, 2, 6, 12, 18 and 24 months following periodontal treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2017
- Study start16 Apr 2013
- Primary completion30 Mar 2020
- Study completion30 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 190 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Deanfield, MD, Study chair, UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03072342
- Sponsor's protocol ID
- 13/0044
- Status last verified
- Feb 2020
- First submitted
- 1 Mar 2017
- Last updated
- 25 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Orlandi M, Masi S, Bhowruth D, Leira Y, Georgiopoulos G, Yellon D, Hingorani A, Chiesa ST, Hausenloy DJ, Deanfield J, D'Aiuto F. Remote Ischemic Preconditioning Protects Against Endothelial Dysfunction in a Human Model of Systemic Inflammation: A Randomized Clinical Trial. Arterioscler Thromb Vasc Biol. 2021 Aug;41(8):e417-e426. doi: 10.1161/ATVBAHA.121.316388. Epub 2021 Jun 10.
PubMed 34107730
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INTENSIVE TREATMENT FOR PERIODONTAL DISEASE: A MODEL OF AND THERAPY OF INFLAMMATORY VASCULAR DYSFUNCTION
- ClinicalTrials.gov ID
- NCT03072342
- Acronym / sponsor ID
- 13/0044
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 190 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- 16 Apr 2013 (actual)
- Primary completion
- 30 Mar 2020 (actual)
- Study completion
- 30 Mar 2020 (actual)
- First posted
- 7 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Periodontal Treatment (IPT) | Active comparator | Procedure: Intensive Periodontal Treatment |
| Control Periodontal Treatment (CPT) | Placebo comparator | Procedure: Control Periodontal Treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must be ≥ 18 years-old.
- Participants must have moderate to severe periodontitis (at least 30 periodontal pockets > 4mm with Bleeding on Probing) and radiographic signs of bone loss.
- Participants must have voluntarily signed the informed consent.
Key exclusion criteria (6 listed)
- Female participant is pregnant or lactating or of childbearing and not using acceptable methods of birth control.
- 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.
- Participant knowingly has HIV or Hepatitis.
- Participant has limited mental capacity or language skills such that simple instructions cannot be followed or information regarding adverse events cannot be provided.
- Participant on chronic antibiotic therapy or who require antibiotic coverage for periodontal procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive Periodontal Treatment | Procedure or surgery | Intensive Periodontal Treatment (IPT) |
| Control Periodontal Treatment | Procedure or surgery | Control Periodontal Treatment (CPT) |
Primary outcome
Common Carotid Intima-media Thickness (cIMT)
Time frame: 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.
5 secondary outcomes
Brachial artery Flow-mediated dilatation (FMD)
Time frame: FMD will be assessed at baseline, 24 hours and 1 week after periodontal treatment
Pulse-wave velocity (PWV)
Time frame: PWV will be assessed at baseline, 2, 6, 12, 18 and 24 months following periodontal treatment
Brachial artery Flow-mediated dilatation (FMD)
Time frame: FMD will be assessed at baseline, 2 , 6 , 12 , 18 and 24 months following periodontal treatment
Blood inflammatory markers
Time frame: Inflammatory mediators profile will be assessed at baseline, 2, 6, 12, 18 and 24 months following periodontal treatment
Oxidative stress
Time frame: Oxidative stress profile will be assessed at baseline, 2, 6, 12, 18 and 24 months following periodontal treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
- Derived from this study: PubMed 34107730Orlandi M, Masi S, Bhowruth D, Leira Y, Georgiopoulos G, Yellon D, Hingorani A, Chiesa ST, Hausenloy DJ, Deanfield J, D'Aiuto F. Remote Ischemic Preconditioning Protects Against Endothelial Dysfunction in a Human Model of Systemic Inflammation: A Randomized Clinical Trial. Arterioscler Thromb Vasc Biol. 2021 Aug;41(8):e417-e426. doi: 10.1161/ATVBAHA.121.316388. Epub 2021 Jun 10.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Deanfield, MD study chair
UCL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive Periodontal Treatment in people with Periodontitis and Intimal Medial Thickness of Internal Carotid Artery, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Common Carotid Intima-media Thickness (cIMT) (time frame: cIMT will be assessed at Baseline, 12 and 24 months after periodontal treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03072342, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2021.