NCT01938183

Brief Summary

Hypothesis: metronidazole gel applied topically after periodontal debridement in smokers volunteers could improve clinical parameters when compared to metronidazole tablets + periodontal debridement. Method: 30 smokers with chronic periodontitis were randomly assigned into 3 groups: periodontal debridement combined with 3 g placebo gel; periodontal debridement combined with daily topical application of 3 g metronidazole benzoate gel (15%); and periodontal debridement combined with a daily single dose of 750 mg metronidazole. Clinical parameters evaluated were visible plaque, gingival bleeding, probing pocket depth and relative attachment level.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2006

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 30, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 10, 2013

Completed
Last Updated

September 10, 2013

Status Verified

September 1, 2013

Enrollment Period

3.3 years

First QC Date

August 30, 2013

Last Update Submit

September 4, 2013

Conditions

Chronic Periodontitis

Keywords

chronic periodontitismetronidazole

Outcome Measures

Primary Outcomes (1)

  • Changes in PPD

    Probing pocket depth (PPD) measured from the bottom of the periodontal pocket to the gingival margin were considering four tooth surfaces: mesial, distal, buccal and lingual. Measurements were performed by a calibrated clinician.

    Change from baseline to 6 months

Secondary Outcomes (4)

  • Changes in microbiological biofilm composition

    Change from baseline to 6 months

  • Changes in VPI

    Change from baseline to 6 months

  • Changes in GBI

    Change from baseline to 6 months

  • Changes in RAL

    Change from baseline to 6 months

Other Outcomes (1)

  • Drug use compliance

    After 8 days of periodontal treatment

Study Arms (3)

Full-mouth PD+placebo gel

PLACEBO COMPARATOR

Full-mouth periodontal debridement using an ultrasonic device in a single session for approximately 1 hour + trays with 3 g of placebo gel (semi-solid suspension containing carbopol), overnight, during seven days.

Procedure: Full-mouth periodontal debridementDrug: placebo gel

Full-mouth PD+Metronidazole tablet

ACTIVE COMPARATOR

Full-mouth periodontal debridement using an ultrasonic device in a single session for approximately 1 hour + single oral dose of 750 mg tablets/day at night, during seven days.

Procedure: Full-mouth periodontal debridementDrug: Metronidazole tablet

Full-mouth PD+Metronidazole benzoate gel

ACTIVE COMPARATOR

Full-mouth periodontal debridement using an ultrasonic device in a single session for approximately 1 hour + trays with 3 g of 15% Mtz benzoate gel (semi-solid suspension containing carbopol), overnight, during seven days.

Procedure: Full-mouth periodontal debridementDrug: Metronidazole benzoate gel

Interventions

Full-mouth periodontal debridementPROCEDURE

full-mouth periodontal debridement using an ultrasonic device in a single session for approximately 1 hour

Also known as: PD
Full-mouth PD+Metronidazole benzoate gelFull-mouth PD+Metronidazole tabletFull-mouth PD+placebo gel
Metronidazole tabletDRUG

750 mg metronidazole tablets

Also known as: MTZ tablet
Full-mouth PD+Metronidazole tablet
placebo gelDRUG

semi-solid suspension containing carbopol

Full-mouth PD+placebo gel
Metronidazole benzoate gelDRUG

15% Mtz benzoate in semi-solid suspension containing carbopol (gel)

Also known as: MTZ GEL
Full-mouth PD+Metronidazole benzoate gel

Eligibility Criteria

Age21 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of chronic periodontitis
  • presence of at least 6 periodontal pockets with a clinical attachment loss of ≥5 mm
  • bleeding on probing (BOP)
  • radiographic bone loss
  • probing pocket depth higher or equal to 5 mm in at least six teeth
  • at least 20 teeth in mouth (third molars excluded)
  • an established smoking habit (at least 10 cigarettes per day for the past 4 years)

You may not qualify if:

  • periapical alterations in qualifying teeth
  • medical disorders requiring prophylactic antibiotic therapy or interfering with the treatment
  • periodontal treatment in the past 6 months
  • use of drugs known to affect periodontal status (antibiotic, anti-inflammatory, anticonvulsant, immunosuppressant and calcium channel blocker) within the past 6 months
  • orthodontic therapy
  • pregnancy and lactation
  • allergy to metronidazole
  • any systemic diseases (e.g.: diabetes and immunological disorders)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Piracicaba Dental School

Piracicaba, São Paulo, 13414903, Brazil

Location

Related Publications (3)

  • Lorentz TC, Cota LO, Cortelli JR, Vargas AM, Costa FO. Prospective study of complier individuals under periodontal maintenance therapy: analysis of clinical periodontal parameters, risk predictors and the progression of periodontitis. J Clin Periodontol. 2009 Jan;36(1):58-67. doi: 10.1111/j.1600-051X.2008.01342.x. Epub 2008 Oct 30.

    PMID: 19017035BACKGROUND

  • Carvalho LH, D'Avila GB, Leao A, Goncalves C, Haffajee AD, Socransky SS, Feres M. Scaling and root planing, systemic metronidazole and professional plaque removal in the treatment of chronic periodontitis in a Brazilian population II--microbiological results. J Clin Periodontol. 2005 Apr;32(4):406-11. doi: 10.1111/j.1600-051X.2005.00720.x.

    PMID: 15811059BACKGROUND

  • Moeintaghavi A, Talebi-ardakani MR, Haerian-ardakani A, Zandi H, Taghipour S, Fallahzadeh H, Pakzad A, Fahami N. Adjunctive effects of systemic amoxicillin and metronidazole with scaling and root planing: a randomized, placebo controlled clinical trial. J Contemp Dent Pract. 2007 Jul 1;8(5):51-9.

    PMID: 17618330BACKGROUND

MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Metronidazole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

NitroimidazolesNitro CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Cristiane C Bergamaschi, PhD

    University of Campinas, Brazil

    PRINCIPAL INVESTIGATOR

  • Francisco C Groppo, PhD

    University of Campinas, Brazil

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

August 30, 2013

First Posted

September 10, 2013

Study Start

November 1, 2006

Primary Completion

March 1, 2010

Study Completion

December 1, 2011

Last Updated

September 10, 2013

Record last verified: 2013-09

Locations

BR(1)