NCT01906450

Brief Summary

Human periodontitis is a group of highly prevalent oral inflammatory diseases and infections with relatively easy treatment and preventive features. The present study is aimed to determine if treating human individuals with chronic periodontitis, along with the use of antibiotics, reduces cardiovascular risk marker (HsPCR) and also intends to identify if severity of periodontitis could be associated with a raise of systemic inflammatory biomarkers on baseline.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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, 2013

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 24, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

July 24, 2013

Status Verified

July 1, 2013

Enrollment Period

4 months

First QC Date

May 23, 2013

Last Update Submit

July 19, 2013

Conditions

Chronic Periodontitis

Outcome Measures

Primary Outcomes (1)

  • EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER HIGH SENSITIVE C-REACTIVE PROTEIN.

    High sensitive C reactive protein - hs-PCR levels evaluate the effect of periodontal therapy alone or with azithromycin on levels of high sensitivity C-reactive protein (hs CRP) in patients with chronic periodontitis

    3 months

Secondary Outcomes (3)

  • STUDY ON THE EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER LIPIDIC PROFILE

    3 months

  • STUDY ON THE EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER GLYCEMIA LEVELS

    3 months

  • STUDY ON THE EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER BLOOD BIOCHEMISTRY

    3 MONTHS

Other Outcomes (1)

  • STUDY ON THE EFFECTS OF PERIODONTAL TREATMENT ALONG WITH THE USE OF ANTIBIOTICS OVER PERIODONTAL PARAMETERS

    3 months

Study Arms (3)

Scaling and root planing plus Azithromycin

EXPERIMENTAL

Single session of scaling and root planning. Azithromycin tablets 500mg, 1 tablet every 24 hours for 5 days

Drug: Scaling and root planing plus Azithromycin

Scaling and root planing plus placebo

PLACEBO COMPARATOR

Single session of scaling and root planning placebo tablets 500mg, 1 tablet every 24 hours for 3 days

Drug: Scaling and root planing plus placebo

baselline screening only

NO INTERVENTION

Dental prophylaxis is offered

Interventions

Scaling and root planing plus AzithromycinDRUG

Single session of scaling and root planning using ultrasonic device. Azithromycin tablets 500mg, 1 tablet every 24 hours for 5 days

Scaling and root planing plus Azithromycin
Scaling and root planing plus placeboDRUG

Single session of scaling and root planning placebo tablets 500mg, 1 tablet every 24 hours for 3 days

Scaling and root planing plus placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • must be of legal age (≥ 18 years old)
  • voluntary participation and signed information consent
  • confirmed systemically healthy individual
  • at least 15 teeth present in mouth

You may not qualify if:

  • pregnant women
  • smokers
  • HIV positive or AIDS
  • Allergic reactions to macrolides and specifically to azithromycin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidad Del Valle

Cali, Colombia

Location

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Tooth ExfoliationRoot PlaningAzithromycin

Condition Hierarchy (Ancestors)

PeriodontitisPeriodontal DiseasesMouth DiseasesStomatognathic DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dental Physiological PhenomenaDigestive System and Oral Physiological PhenomenaDental ScalingDental ProphylaxisPeriodonticsDentistrySubgingival CurettagePreventive DentistryErythromycinMacrolidesPolyketidesLactonesOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
periodontist Cert. DDS

Study Record Dates

First Submitted

May 23, 2013

First Posted

July 24, 2013

Study Start

May 1, 2013

Primary Completion

September 1, 2013

Study Completion

January 1, 2014

Last Updated

July 24, 2013

Record last verified: 2013-07

Locations

CO(1)