NCT00066001

Brief Summary

The purpose of this study is to determine the clinical and microbiological effects of systemically administered metronidazole alone or in combination with professional plaque removal on periodontally diseased patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
154

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Dec 2002

Longer than P75 for phase_2

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

August 1, 2003

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 5, 2003

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

November 9, 2010

Status Verified

November 1, 2010

Enrollment Period

5 years

First QC Date

August 1, 2003

Last Update Submit

November 8, 2010

Conditions

PeriodontitisPeriodontal Diseases

Outcome Measures

Primary Outcomes (1)

  • Change in mean attachment level

    Baseline, 3, 6 12 18 and 24 months

Study Arms (1)

1, 2, 3, 4

PLACEBO COMPARATOR

The 4 arms of the study are based on the treatment groups: 1. scaling and root planing alone (SRP); 2. SRP plus repeated professional supragingival plaque removal; 3. SRP + systemically administered metronidazole; 4. SRP + repeated professional supragingival plaque removal + systemically administered metronidazole.

Drug: metronidazole

Interventions

metronidazoleDRUG

antibiotic that is particularly effective against Gram negative bacterial species

1, 2, 3, 4

Eligibility Criteria

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

You may qualify if:

  • \> 35 years of age
  • \> 20 teeth
  • \> 5% sites (approx. 8 sites) with pocket depth \> 4 mm and / or 5% sites with attachment level \> 4 mm

You may not qualify if:

  • \> 50% of sites with pocket depth or attachment level \> 4 mm
  • Pregnancy or lactation
  • Periodontal or antibiotic therapy in the previous 12 months
  • Any systemic condition which might influence the course of periodontal disease or treatment (e.g. diabetes, AIDS)
  • Any systemic condition which requires antibiotic coverage for routine periodontal procedures (e.g. heart conditions, joint replacements etc.)
  • Any known allergy to metronidazole

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Periodontology, The Forsyth Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

PeriodontitisPeriodontal Diseases

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

NitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Ann Haffajee

    Boston, MA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 1, 2003

First Posted

August 5, 2003

Study Start

December 1, 2002

Primary Completion

December 1, 2007

Study Completion

December 1, 2009

Last Updated

November 9, 2010

Record last verified: 2010-11

Locations

US(1)