NCT01046435

Brief Summary

The purpose of this study is to determine if treating periodontal infections (gum disease) will reduce markers of systemic inflammation in patients at risk of cardiovascular diseases.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
186

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

March 1, 2007

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 12, 2010

Completed
Last Updated

March 25, 2010

Status Verified

May 1, 2006

Enrollment Period

2 years

First QC Date

January 11, 2010

Last Update Submit

March 24, 2010

Conditions

Periodontal DiseaseCardiovascular DiseaseType 2 DiabetesObesityMetabolic Syndrome

Keywords

periodontitiscardiovascular diseasediabetes

Outcome Measures

Primary Outcomes (1)

  • Serum levels of C-reactive protein, fibrinogen,erythrosedimentation rate and white blood cell count

    0, 3, 6, 9 and 12 months after therapy

Secondary Outcomes (1)

  • Clinical periodontal parameters: probing depth, bleeding on probing, clinical attachment level

    0, 3, 6, 9 and 12 months after therapy

Study Arms (2)

Supragingival scaling plus placebo

PLACEBO COMPARATOR

Plaque control instructions, supra gingival scaling and two placebos

Procedure: metronidazole and amoxicillinProcedure: Two placebos

Root planing plus antibiotics

EXPERIMENTAL

Plaque control instructions, subgingival scaling,root planing, metronidazole 250 mg and amoxicillin 500 mg. three times a day for 7 days

Procedure: metronidazole and amoxicillinProcedure: Two placebos

Interventions

metronidazole and amoxicillinPROCEDURE

Metronidazole 250 mg three times a day per 7 days

Also known as: Non-surgical periodontal therapy
Root planing plus antibioticsSupragingival scaling plus placebo
Two placebosPROCEDURE

Two placebos 3 times a day for 7 days

Also known as: Community periodontal treatment
Root planing plus antibioticsSupragingival scaling plus placebo

Eligibility Criteria

Age35 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinically diagnosis of marginal periodontitis
  • No history of periodontal treatment
  • At least 14 natural teeth present
  • Dyslipidemia
  • And at least one of the following factors:
  • obesity
  • diabetes
  • smoking, hypertension

You may not qualify if:

  • Rheumatoid arthritis
  • Any type of cancer in the previous 2 years
  • Pregnancy and lactation
  • Indication of the use of antibiotic for invasive procedures
  • Use of antibiotics in previous three months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dra Eloisa Díaz Health Center, Metropolitan Northen Health Service

Santiago, Santiago Metropolitan, Chile

Location

Related Links

MeSH Terms

Conditions

Periodontal DiseasesCardiovascular DiseasesDiabetes Mellitus, Type 2ObesityMetabolic SyndromePeriodontitisDiabetes Mellitus

Interventions

MetronidazoleAmoxicillinPeriodontal Index

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsInsulin ResistanceHyperinsulinism

Intervention Hierarchy (Ancestors)

NitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsAmpicillinPenicillin GPenicillinsbeta-LactamsLactamsAmidesSulfur CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingDental Health SurveysHealth SurveysSurveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesDentistryPeriodonticsHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public HealthPublic Health Dentistry

Study Officials

  • Nestor J. Lopez, DDS

    University of Chile

    PRINCIPAL INVESTIGATOR

  • Antonio Quintero, DDS

    University of Chile

    PRINCIPAL INVESTIGATOR

  • Carola Ibieta, DDS

    University of Chile

    STUDY CHAIR

  • Carlos Y Valenzuela, DMS, PhD

    University of Chile

    STUDY CHAIR

  • Lilian Jara, MsB, PhD

    University of Chile

    STUDY CHAIR

  • Marcelo Llancaqueo, DMS

    University of Chile

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 11, 2010

First Posted

January 12, 2010

Study Start

March 1, 2007

Primary Completion

March 1, 2009

Study Completion

March 1, 2009

Last Updated

March 25, 2010

Record last verified: 2006-05

Locations

CL(1)