NCT02977351

Brief Summary

Determine the relationship between the systemic indications of atherosclerosis by means of the change in the ratio of periodontopathogenic microorganisms following periodontal treatment of individuals who have been diagnosed with chronic periodontitis-atherosclerosis and for individuals who have been diagnosed with systemically healthy-chronic periodontitis.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2014

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 15, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 30, 2016

Completed
Last Updated

November 30, 2016

Status Verified

November 1, 2016

Enrollment Period

1 year

First QC Date

November 15, 2016

Last Update Submit

November 29, 2016

Conditions

AtherosclerosisChronic Periodontitis

Keywords

Periodontopathogenic microorganismsNon-surgical periodontal treatment

Outcome Measures

Primary Outcomes (1)

  • Periodontopathogenic microorganism levels

    1 year

Study Arms (2)

Atherosclerosis

EXPERIMENTAL

Patients with atherosclerosis and chronic periodontitis

Procedure: Non-surgical periodontal treatment

Systemically healthy

ACTIVE COMPARATOR

Patients with Systemically healthy and chronic periodontitis.

Procedure: Non-surgical periodontal treatment

Interventions

Non-surgical periodontal treatmentPROCEDURE
AtherosclerosisSystemically healthy

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • had no systemic disease,
  • had not used any antibiotics
  • had not used medications with an impact on the immune system,
  • had not received any periodontal and/or medical treatment within the last 6 months.

You may not qualify if:

  • smokers of cigarettes or other tobacco products,
  • pregnant or breastfeeding,
  • non-stable cardiovascular condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

AtherosclerosisChronic Periodontitis

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 15, 2016

First Posted

November 30, 2016

Study Start

January 1, 2014

Primary Completion

January 1, 2015

Study Completion

January 1, 2016

Last Updated

November 30, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share