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

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ClinicalTrials.gov Identifier: NCT01938183
Recruitment Status : Completed
First Posted : September 10, 2013
Last Update Posted : September 10, 2013
Sponsor:
Collaborator:
Faculty Sao Leopoldo Mandic Campinas
Information provided by (Responsible Party):
Francisco Groppo, University of Campinas, Brazil

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.

Condition or disease Intervention/treatment Phase
Chronic Periodontitis Procedure: Full-mouth periodontal debridement Drug: Metronidazole tablet Drug: placebo gel Drug: Metronidazole benzoate gel Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Full-mouth Periodontal Debridement With or Without Adjunctive Metronidazole Gel in Smoking Patients With Chronic Periodontitis
Study Start Date : November 2006
Actual Primary Completion Date : March 2010
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


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 Name: 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 Name: PD

Drug: Metronidazole tablet
750 mg metronidazole tablets
Other Name: 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 Name: PD

Drug: Metronidazole benzoate gel
15% Mtz benzoate in semi-solid suspension containing carbopol (gel)
Other Name: MTZ GEL




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01938183


Locations
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Brazil
Piracicaba Dental School
Piracicaba, SP, Brazil, 13414903
Sponsors and Collaborators
University of Campinas, Brazil
Faculty Sao Leopoldo Mandic Campinas
Investigators
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Principal Investigator: Cristiane C Bergamaschi, PhD University of Campinas, Brazil
Study Chair: Francisco C Groppo, PhD University of Campinas, Brazil

Publications:
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Responsible Party: Francisco Groppo, Full Professor, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT01938183     History of Changes
Other Study ID Numbers: MTZ085-2006
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: September 10, 2013
Last Verified: September 2013

Keywords provided by Francisco Groppo, University of Campinas, Brazil:
chronic periodontitis
metronidazole

Additional relevant MeSH terms:
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Periodontitis
Chronic Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Metronidazole
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents