Full-mouth Periodontal Debridement and Metronidazole Gel in Patients With Chronic Periodontitis

September 4, 2013 updated by: Francisco Groppo, University of Campinas, Brazil

Full-mouth Periodontal Debridement With or Without Adjunctive Metronidazole Gel in Smoking Patients With Chronic Periodontitis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background. The benefit of adjunctive metronidazole on periodontal procedure in smokers with chronic periodontitis (CP) is uncertain. The authors compared the effect of metronidazole (Mtz) on full-mouth periodontal debridement (PD= 1 hour of ultrasonic calculus/plaque removal) in smokers with CP.

Methods. This pilot study involved 30 Individuals (having at least six teeth with a clinical attachment loss of ≥ 5 mm and probing pocket depth (PPD) of ≥5 mm) that were randomly assigned into three groups (n=10): 1) PD plus 3 g of placebo gel daily topical application 2) PD plus daily topical application of 3 g of 15% Mtz benzoate gel; and 3) PD plus a daily single dose of 750 mg Mtz (Flagyl®). Clinical parameters visible plaque index (VPI), gingival bleeding index (GBI), relative attachment level (RAL) and PPD; and the quantitative analysis (real-time PCR) of Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis and Tannerella forsythia were assessed baseline, 1, 3 and 6 months after PD.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Piracicaba, SP, Brazil, 13414903
        • Piracicaba Dental School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Full-mouth PD+placebo gel
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 debridement
full-mouth periodontal debridement using an ultrasonic device in a single session for approximately 1 hour
Other Names:
  • PD
Drug: placebo gel
semi-solid suspension containing carbopol
ACTIVE_COMPARATOR: Full-mouth PD+Metronidazole tablet
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 debridement
full-mouth periodontal debridement using an ultrasonic device in a single session for approximately 1 hour
Other Names:
  • PD
Drug: Metronidazole tablet
750 mg metronidazole tablets
Other Names:
  • MTZ tablet
ACTIVE_COMPARATOR: Full-mouth PD+Metronidazole benzoate gel
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 debridement
full-mouth periodontal debridement using an ultrasonic device in a single session for approximately 1 hour
Other Names:
  • PD
Drug: Metronidazole benzoate gel
15% Mtz benzoate in semi-solid suspension containing carbopol (gel)
Other Names:
  • MTZ GEL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in PPD
Time Frame: Change from baseline to 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in microbiological biofilm composition
Time Frame: Change from baseline to 6 months
Subgingival biofilm samples were collected from five pockets of each patient, present 5-6mm at the baseline period in a single root tooth.
Change from baseline to 6 months
Changes in VPI
Time Frame: Change from baseline to 6 months
Visible plaque index (VPI) measured on four tooth surfaces: mesial, distal, buccal and lingual. Measurements were performed by a calibrated clinician.
Change from baseline to 6 months
Changes in GBI
Time Frame: Change from baseline to 6 months
Gingival bleeding index (GBI) measured on four tooth surfaces: mesial, distal, buccal and lingual. Measurements were performed by a calibrated clinician.
Change from baseline to 6 months
Changes in RAL
Time Frame: Change from baseline to 6 months
Relative attachment level (RAL) measured from the stent to the bottom of periodontal pocket. Measurements were performed by a calibrated clinician.
Change from baseline to 6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Drug use compliance
Time Frame: After 8 days of periodontal treatment
Drug use compliance was measured by salivary drug concentration on the eighth day after periodontal debridement.
After 8 days of periodontal treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Campinas, Brazil

Collaborators

Faculty Sao Leopoldo Mandic Campinas

Investigators

  • Principal Investigator: Cristiane C Bergamaschi, PhD, University of Campinas, Brazil
  • Study Chair: Francisco C Groppo, PhD, University of Campinas, Brazil

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (ACTUAL)

March 1, 2010

Study Completion (ACTUAL)

December 1, 2011

Study Registration Dates

First Submitted

August 30, 2013

First Submitted That Met QC Criteria

September 4, 2013

First Posted (ESTIMATE)

September 10, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

September 10, 2013

Last Update Submitted That Met QC Criteria

September 4, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MTZ085-2006

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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