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Chronic PeriodontitisPhase 2NCT01938183

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

A Phase 2 study testing Full-mouth periodontal debridement, Metronidazole tablet and Metronidazole benzoate gel in people with Chronic Periodontitis, run by University of Campinas, Brazil at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Hypothesis: metronidazole gel applied topically after periodontal debridement in smokers volunteers could improve clinical parameters when compared to metronidazole tablets + periodontal debridement. Read more about this study

Who is it for?
Ages 21 to 70 years
Conditions the study is for
Chronic Periodontitis
What is being tested?
Full-mouth periodontal debridement, Metronidazole tablet and Metronidazole benzoate gel
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteBrazil
Study dates
Nov 2006to Dec 2011
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Piracicaba Dental School

    Piracicaba, São Paulo, 13414903

Other trials in Brazil

About this study

Official title: 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.

Read the 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.

Being tested
Full-mouth periodontal debridement, Metronidazole tablet, placebo gel, Metronidazole benzoate gel
Keywords
chronic periodontitis, metronidazole
Medical subject headings
Chronic Periodontitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Full-mouth periodontal debridementProcedure or surgery

    Also called PD

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

  • Metronidazole tabletDrug

    Also called MTZ tablet

    750 mg metronidazole tablets

  • placebo gelDrug

    semi-solid suspension containing carbopol

  • Metronidazole benzoate gelDrug

    Also called MTZ GEL

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

Study groups in NCT01938183
Study groupRoleWhat they receive
Full-mouth PD+placebo gelPlacebo comparatorFull-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.
Receives: Procedure: Full-mouth periodontal debridement; Drug: placebo gel
Full-mouth PD+Metronidazole tabletActive comparatorFull-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.
Receives: Procedure: Full-mouth periodontal debridement; Drug: Metronidazole tablet
Full-mouth PD+Metronidazole benzoate gelActive comparatorFull-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.
Receives: Procedure: Full-mouth periodontal debridement; Drug: Metronidazole benzoate gel

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Change from baseline to 6 months

Secondary outcomes (4)

  1. Changes in microbiological biofilm composition

    Subgingival biofilm samples were collected from five pockets of each patient, present 5-6mm at the baseline period in a single root tooth.

    Measured: Change from baseline to 6 months

  2. Changes in VPI

    Visible plaque index (VPI) measured on four tooth surfaces: mesial, distal, buccal and lingual. Measurements were performed by a calibrated clinician.

    Measured: Change from baseline to 6 months

  3. Changes in GBI

    Gingival bleeding index (GBI) measured on four tooth surfaces: mesial, distal, buccal and lingual. Measurements were performed by a calibrated clinician.

    Measured: Change from baseline to 6 months

  4. Changes in RAL

    Relative attachment level (RAL) measured from the stent to the bottom of periodontal pocket. Measurements were performed by a calibrated clinician.

    Measured: Change from baseline to 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Sep 2013 (estimated)
  2. Study startNov 2006
  3. Primary completionMar 2010
  4. Study completionDec 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01938183
Sponsor's protocol ID
MTZ085-2006
Status last verified
Sep 2013
First submitted
30 Aug 2013
Last updated
10 Sep 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 19017035

  • 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.

    PubMed 15811059

  • 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.

    PubMed 17618330

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Full-mouth periodontal debridement, Metronidazole tablet and Metronidazole benzoate gel in people with Chronic Periodontitis, run by University of Campinas, Brazil at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in PPD (time frame: Change from baseline to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01938183, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2013.

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