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Completed

NCT Number: NCT01938183

Full-mouth Periodontal Debridement and Metronidazole Gel in 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.

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Key information

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Piracicaba Dental School

Piracicaba, São Paulo, 13414903, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Full-mouth periodontal debridement

Procedure

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

Other names: PD

Metronidazole Tablet

Drug

750 mg metronidazole tablets

Other names: MTZ tablet

Placebo Gel

Drug

semi-solid suspension containing carbopol

Metronidazole benzoate gel

Drug

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

Other names: MTZ GEL

Primary outcomes

  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 outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Campinas, Brazil

Other

Collaborators

  • Faculty Sao Leopoldo Mandic Campinas

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2010
Study completion
2011
First posted
Sep 10, 2013
Registry last updated
Sep 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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