NCT01405365

Brief Summary

The purpose of this study is to investigate the effect that obesity may have on the nonsurgical treatment (with and without the adjunct use of metronidazole) of destructive periodontal diseases (chronic periodontitis).

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
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2009

Longer than P75 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

August 1, 2009

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

August 23, 2010

Completed
11 months until next milestone

First Posted

Study publicly available on registry

July 29, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

July 29, 2011

Status Verified

August 1, 2010

Enrollment Period

2.3 years

First QC Date

August 23, 2010

Last Update Submit

July 28, 2011

Conditions

PeriodontitisPeriodontal DiseasesObesity

Keywords

PeriodontitisPeriodontal diseasesObesityMetronidazolePrognosisProbing depthPeriodontal attachment loss

Outcome Measures

Primary Outcomes (1)

  • Probing depth

    Defined as the distance from the free gingival margin to the bottom of the pocket/sulcus.

    12 months

Secondary Outcomes (1)

  • Attachment level

    12 months

Study Arms (2)

Metronidazole

EXPERIMENTAL
Drug: MetronidazoleProcedure: Scaling and root planning

Placebo

PLACEBO COMPARATOR
Drug: PlaceboProcedure: Scaling and root planning

Interventions

Scaling and root planningPROCEDURE

Scaling and root planning performed with curettes and ultrasonic scalers under local anesthesia

Also known as: Nonsurgical periodontal therapy
MetronidazolePlacebo
MetronidazoleDRUG

Metronidazole 400mg TID for 10 days

Also known as: Flagyl
Metronidazole
PlaceboDRUG

Placebo pill TID for 10 days

Also known as: Inactive Substance, Inactive Drug
Placebo

Eligibility Criteria

Age35 Years - 55 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Normal weight or obese (according to BMI)
  • nonsmokers or former smokers (3 or more years)
  • no systemic diseases that may affect periodontal treatment (diabetes, osteoporosis, steroid use)
  • have 10 teeth present
  • have at least 2 teeth with probing depth 6+mm and attachment loss 4+mm

You may not qualify if:

  • Pregnancy
  • Development of diabetes or other conditions that may impair periodontal healing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

RECRUITING

MeSH Terms

Conditions

PeriodontitisPeriodontal DiseasesObesityPeriodontal Attachment Loss

Interventions

MetronidazoleTooth Exfoliation

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPeriodontal Atrophy

Intervention Hierarchy (Ancestors)

NitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsDental Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Officials

  • Cassiano K Rosing, DDS, PhD

    Federal University of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

  • Cristiano Susin, DDS, PhD

    Medical College of Georgia School of Dentistry

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Eduardo J Gaio, DDS

CONTACT

55 51 9252 4577dudagaio@hotmail.com

Juliano Cavagni, DDS

CONTACT

55 54 8111 9440jcavagni@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 23, 2010

First Posted

July 29, 2011

Study Start

August 1, 2009

Primary Completion

December 1, 2011

Study Completion

December 1, 2012

Last Updated

July 29, 2011

Record last verified: 2010-08

Locations

BR(1)