NCT00681564

Brief Summary

The purpose of this study is to determine the effect of periodontal therapy on endothelial function and other biomarkers of cardiovascular disease

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started May 2008

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

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

May 1, 2008

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 21, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

April 1, 2014

Completed
Last Updated

April 17, 2014

Status Verified

March 1, 2014

Enrollment Period

2.8 years

First QC Date

May 19, 2008

Results QC Date

November 26, 2013

Last Update Submit

March 31, 2014

Conditions

Periodontitis

Keywords

PeriodontitisOral healthCardiovascular disease

Outcome Measures

Primary Outcomes (1)

  • Brachial Artery Flow-mediated Dilation

    All the assessments of vascular function were performed in the morning, in a temperature controlled room, with participants required to fast for at least 8 hours. Flow-mediated, endothelium dependent vasodilatation of the brachial artery (FMD) was measured using the technique described by Celermajer et al. using the guidelines reported by Coretti et al. FMD was calculated as the percentage of change in the diameter of brachial artery measured 45-60 s after cuff release in relation to the baseline measure (FMD%).

    Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy

Secondary Outcomes (11)

  • High-sensitivity C-Reactive Protein

    Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy

  • Total Cholesterol

    Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy

  • White Blood Cell Count

    Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy

  • Subgingival Microbiota

    12 weeks post-periodontal therapy

  • LDL Cholesterol

    Baseline; 24 hours post periodontal therapy; 12 weeks post periodontal therapy

  • +6 more secondary outcomes

Study Arms (2)

One-Stage Full-Mouth Disinfection

EXPERIMENTAL

Scaling and root planing, four quadrants in one session Tongue brushing with a 1% chlorhexidine gel (1 minute) Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes) Subgingival chlorhexidine (1%) irrigation in all pockets Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention Basic oral hygiene instructions Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)

Procedure: One-Stage Full-Mouth Disinfection

Periodontal care

ACTIVE COMPARATOR

Basic oral hygiene instructions Supragingival plaque removal

Procedure: Periodontal care

Interventions

One-Stage Full-Mouth DisinfectionPROCEDURE

* Scaling and root planing, four quadrants in one session * Tongue brushing with a 1% chlorhexidine gel (1 minute) * Mouth rinsing with a 0.2% chlorhexidine solution for (2 minutes) * Subgingival chlorhexidine (1%) irrigation in all pockets * Twice daily rinsing with clorhexidine (1 minute) during fourteen days after the periodontal intervention * Basic oral hygiene instructions * Dental extractions will be performed at the end of patient followup (only in cases of teeth that could not be saved)

One-Stage Full-Mouth Disinfection
Periodontal carePROCEDURE

* Basic oral hygiene instructions * Supragingival plaque removal

Periodontal care

Eligibility Criteria

Age25 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects must be 25 years of age or older
  • Three or more periodontal pockets with a probing depth (PD) \> 5mm
  • Have at least 20 natural teeth
  • Provide informed consent and willingness to cooperate with the study protocol

You may not qualify if:

  • History of antibiotic use in the previous three months
  • Pregnant or lactating females
  • Treatment with antihypertensive, antilipemic, antiarrhythmic, and other cardiovascular drugs
  • Systemic diseases such as diabetes, HIV/AIDS, liver disease, chronic renal failure, tuberculosis, and autoimmune diseases
  • Previous history of cardiovascular disease: Acute myocardial infarct, stable angina, unstable angina, heart failure, atrial fibrillation, atrioventricular block, peripheral vascular disease, cerebrovascular accident
  • Patients who received periodontal treatment within the last 3 months
  • Patients who require antibiotic prophylaxis before examination or treatment
  • Patients with mental retardation and dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Red de Salud de Ladera E.S.E. Servicio de Odontología

Cali, Valle del Cauca Department, Colombia

Location

Universidad del Valle, Facultad de Salud, Escuela de Odontología

Cali, Valle del Cauca Department, Colombia

Location

Related Publications (2)

  • Ramirez JH, Parra B, Gutierrez S, Arce RM, Jaramillo A, Ariza Y, Contreras A. Biomarkers of cardiovascular disease are increased in untreated chronic periodontitis: a case control study. Aust Dent J. 2014 Mar;59(1):29-36. doi: 10.1111/adj.12139. Epub 2014 Feb 4.

    PMID: 24495202RESULT

  • Ramirez JH, Arce RM, Contreras A. Periodontal treatment effects on endothelial function and cardiovascular disease biomarkers in subjects with chronic periodontitis: protocol for a randomized clinical trial. Trials. 2011 Feb 16;12:46. doi: 10.1186/1745-6215-12-46.

    PMID: 21324167DERIVED

MeSH Terms

Conditions

PeriodontitisCardiovascular Diseases

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Limitations and Caveats

1\. Patient recruitment take more time that previously expected, 2. Longer time than expected for the standardization for laboratory techniques, 3. Changes of the study personnel during patient recruitment and laboratory analysis of biological samples

Results Point of Contact

Title
Jorge Hernán Ramírez and Adolfo Contreras (adolfo@yahoo.com).
Organization
Universidad del Valle
jorge.h.ramirez00@gmail.com
5723753778

Study Officials

  • Adolfo Contreras, DDS, MS, PhD

    Universidad del Valle

    PRINCIPAL INVESTIGATOR

  • Jorge H Ramirez, MD, MS

    Universidad del Valle

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

May 19, 2008

First Posted

May 21, 2008

Study Start

May 1, 2008

Primary Completion

March 1, 2011

Study Completion

January 1, 2012

Last Updated

April 17, 2014

Results First Posted

April 1, 2014

Record last verified: 2014-03

Locations

CO(2)