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Chronic PeriodontitisPhase 4NCT02735395

Dose and Duration of Metronidazole and Amoxicillin for Treatment of Chronic Periodontitis

A Phase 4 study testing Scaling and root planing (SRP), Metronidazole 250 (7 days) and Metronidazole 400 (7 days) in people with Chronic Periodontitis, run by University of Guarulhos at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study was to compare the clinical and microbiological outcomes of different dosages of metronidazole (MTZ) and of the duration of the systemic administration of MTZ and amoxicillin as adjunct to scaling and root planing (SRP) in the treatment of generalized chronic periodontitis (GChP). Read more about this study

Who is it for?
Ages 30 years and older
Conditions the study is for
Chronic Periodontitis
What is being tested?
Scaling and root planing (SRP), Metronidazole 250 (7 days) and Metronidazole 400 (7 days)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
110 participants
Where
1 siteBrazil
Study dates
Jul 2011to Dec 2020
Phase
Phase 4
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 30 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥30 years of age;
  • at least 15 teeth (excluding third molars and teeth with advanced decay indicated for extraction)
  • a minimum of 6 teeth with at least one site each with probing depth (PD) and clinical * attachment level (CAL) ≥5 mm;
  • at least 30% of the sites with PD and CAL ≥4 mm and bleeding on probing (BOP).

Who cannot join

  • pregnancy
  • breastfeeding
  • current smoking and former smoking within the past 5 years;
  • systemic diseases that could affect the progression of periodontitis (e.g. diabetes, immunological disorders, osteoporosis);
  • scaling and root planing an in the previous 12 months;
  • antibiotic therapy in the previous 6 months;
Show all 9Show fewer
  • long-term intake of anti-inflammatory medications;
  • need for antibiotic pre-medication for routine dental therapy;
  • allergy to metronidazole and/or amoxicillin.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Guarulhos University

    Guarulhos, São Paulo, 07023-070

Other trials in Brazil

About this study

Official title: Impact of Different Dosages and Time of Administration of Metronidazole and Amoxicillin in the Treatment of Generalized Chronic Periodontitis: A Randomized Clinical Trial

The aim of this study was to compare the clinical and microbiological outcomes of different dosages of metronidazole (MTZ) and of the duration of the systemic administration of MTZ and amoxicillin as adjunct to scaling and root planing (SRP) in the treatment of generalized chronic periodontitis (GChP).

Read the detailed description

Randomized clinical trials and systematic reviews have shown that the use of the combination of metronidazole (MTZ) and amoxicillin (AMX) significantly improves the benefits of the SRP in the treatment of subjects with periodontitis. However, the optimal dosage and interval of administration of these antibiotics are still unclear. Therefore, the aim of this study was to compare the clinical and microbiological outcomes of different dosages and duration of the systemic administration of the combination of MTZ and AMX as adjunct to scaling and root planing (SRP) in the treatment of generalized chronic periodontitis (GChP). One hundred ten subjects will be randomly assigned to receive SRP plus placebo, or SRP combined with 250 mg or 400 mg of MTZ, plus AMX (500 mg) TID, for either 7 or 14 days. Subjects will be clinically and microbiologically monitored up to 1 year post-therapy.

Being tested
Scaling and root planing (SRP), Metronidazole 250 (7 days), Metronidazole 400 (7 days), Metronidazole 250 (14 days), Metronidazole 400 (14 days)
Keywords
Periodontal Diseases, Metronidazole, Amoxicillin, Chronic periodontitis, Root Planing
Medical subject headings
Chronic Periodontitis, Periodontal Diseases

What participants receive

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

  • Scaling and root planing (SRP)Procedure or surgery

    SRP performed in four to six appointments lasting approximately 1 h each, using manual curettes (Hu-Friedy, Chicago, IL, USA) and ultrasonic device (Cavitron Select SPC, Dentsply professional, York, PA, USA) under local anesthesia. The deep sites will be scaled throughout the first week and treatment of the entire oral cavity will be completed in 14 days.

  • Metronidazole 250 (7 days)Drug

    Subjects will intake Metronidazole 250 mg. for 7 days, starting immediately after the first session of Scaling and Root Planing.

  • Metronidazole 400 (7 days)Drug

    Subjects will intake Metronidazole 400 mg. for 7 days, starting immediately after the first session of Scaling and Root Planing.

  • Metronidazole 250 (14 days)Drug

    Subjects will intake Metronidazole 250 mg. for 14 days, starting immediately after the first session of Scaling and Root Planing.

  • Metronidazole 400 (14 days)Drug

    Subjects will intake Metronidazole 400 mg. for 14 days, starting immediately after the first session of Scaling and Root Planing.

  • AmoxicillinDrug

    Subjects will intake Amoxicillin 500 mg. for 14 days, starting immediately after and the first session of Scaling and Root Planing.

  • Placebo 250 (7 days)Other

    Subjects will intake placebo of Metronidazole 250 mg. for 7 days, starting immediately after to intake Metronidazole 250 mg.

  • Placebo 400 (7 days)Other

    Subjects will intake placebo of Metronidazole 400 mg. for 7 days, starting immediately after to intake Metronidazole 400 mg.

  • Placebo 400 (14 days)Other

    Subjects will intake placebo of Metronidazole 400 mg. for 14 days, starting immediately after the first session of Scaling and Root Planing.

  • Placebo 500Other

    Subjects will intake placebo of Amoxicillin 500 mg. for 14 days, starting immediately after the first session of Scaling and Root Planing.

Study groups in NCT02735395
Study groupRoleWhat they receive
ControlPlacebo comparatorScaling and root planing (SRP) + two placebo pills thrice a day (TID) for 14 days (control group)
Receives: Procedure: Scaling and root planing (SRP); Other: Placebo 400 (14 days); Other: Placebo 500
MTZ 250 (7 days)Active comparatorSRP + MTZ (250mg/TID) + AMX, for 7 days and placebos for another 7 days
Receives: Procedure: Scaling and root planing (SRP); Drug: Metronidazole 250 (7 days); Drug: Amoxicillin; Other: Placebo 250 (7 days)
MTZ 400 (7 days)Active comparatorSRP + MTZ (400mg/TID) + AMX, for 7 days and placebos for another 7 days
Receives: Procedure: Scaling and root planing (SRP); Drug: Metronidazole 400 (7 days); Drug: Amoxicillin; Other: Placebo 400 (7 days)
MTZ 250 (14 days)Active comparatorSRP +MTZ (250mg/TID) + AMX for 14 days
Receives: Procedure: Scaling and root planing (SRP); Drug: Metronidazole 250 (14 days); Drug: Amoxicillin
MTZ 400 (14 days)Active comparatorSRP +MTZ (400mg/TID) + AMX for 14 days
Receives: Procedure: Scaling and root planing (SRP); Drug: Metronidazole 400 (14 days); Drug: Amoxicillin

What is being measured

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

  1. Percentage of subjects reaching ≤ 4 periodontal sites with probing depth (PD) ≥ 5 mm at 12 months

    Measured: 12 months

Secondary outcomes (19)

  1. Number of sites with PD ≥ 5 mm

    Measured: Baseline, 3, 6 and 12 months

  2. Number of sites with PD ≥ 6 mm

    Measured: Baseline, 3, 6 and 12 months

  3. Number of sites with PD ≥ 7 mm

    Measured: Baseline, 3, 6 and 12 months

  4. Reduction in the number of sites with PD ≥ 5 mm

    Measured: Baseline, 3, 6 and 12 months

  5. Reduction in the number of sites with PD ≥ 6 mm

    Measured: Baseline, 3, 6 and 12 months

  6. Reduction in the number of sites with PD ≥ 7 mm

    Measured: Baseline, 3, 6 and 12 months

  7. Full-mouth PD

    Measured: Baseline, 3, 6 and 12 months

  8. Full-mouth clinical attachment level

    Measured: Baseline, 3, 6 and 12 months

  9. Percentage of sites with bleeding on probing

    Measured: Baseline, 3, 6 and 12 months

  10. Percentage of sites with plaque accumulation

    Measured: Baseline, 3, 6 and 12 months

  11. Percentage of sites with marginal bleeding

    Measured: Baseline, 3, 6 and 12 months

  12. Occurrence of headache obtained through a questionnaire of adverse effects

    Measured: 14 days after the beginning of treatments

  13. Occurrence of vomiting obtained through a questionnaire of adverse effects

    Measured: 14 days after the beginning of treatments

  14. Occurrence of diarrhea obtained through a questionnaire of adverse effects

    Measured: 14 days after the beginning of treatments

  15. Occurrence of metallic taste obtained through a questionnaire of adverse effects

    Measured: 14 days after the beginning of treatments

  16. Occurrence of nausea obtained through a questionnaire of adverse effects

    Measured: 14 days after the beginning of treatments

  17. Occurrence of irritability obtained through a questionnaire of adverse effects

    Measured: 14 days after the beginning of treatments

  18. Proportions of periodontal pathogenic bacterial species

    Measured: Baseline, 3, 6 and 12 months

  19. Counts of periodontal pathogenic bacterial species

    Measured: Baseline, 3, 6 and 12 months

Timeline

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

  1. First posted12 Apr 2016 (estimated)
  2. Study startJul 2011
  3. Primary completionMay 2014
  4. Study completionDec 2020 (estimated)

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02735395
Sponsor's protocol ID
SISNEP/513
Status last verified
Jan 2020
First submitted
22 Mar 2016
Last updated
13 Jan 2020
Results posted
No
Data monitoring committee
No

Publications

  • Aimetti M, Romano F, Guzzi N, Carnevale G. Full-mouth disinfection and systemic antimicrobial therapy in generalized aggressive periodontitis: a randomized, placebo-controlled trial. J Clin Periodontol. 2012 Mar;39(3):284-94. doi: 10.1111/j.1600-051X.2011.01795.x. Epub 2012 Jan 4.

    PubMed 22220822

  • Carvalho LH, D'Avila GB, Leao A, 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. I. clinical results. J Clin Periodontol. 2004 Dec;31(12):1070-6. doi: 10.1111/j.1600-051X.2004.00605.x.

    PubMed 15560807

  • Cionca N, Giannopoulou C, Ugolotti G, Mombelli A. Amoxicillin and metronidazole as an adjunct to full-mouth scaling and root planing of chronic periodontitis. J Periodontol. 2009 Mar;80(3):364-71. doi: 10.1902/jop.2009.080540.

    PubMed 19254119

  • Feres M, Figueiredo LC, Soares GM, Faveri M. Systemic antibiotics in the treatment of periodontitis. Periodontol 2000. 2015 Feb;67(1):131-86. doi: 10.1111/prd.12075.

    PubMed 25494600

  • Feres M, Soares GM, Mendes JA, Silva MP, Faveri M, Teles R, Socransky SS, Figueiredo LC. Metronidazole alone or with amoxicillin as adjuncts to non-surgical treatment of chronic periodontitis: a 1-year double-blinded, placebo-controlled, randomized clinical trial. J Clin Periodontol. 2012 Dec;39(12):1149-58. doi: 10.1111/jcpe.12004. Epub 2012 Sep 27.

    PubMed 23016867

  • Guerrero A, Griffiths GS, Nibali L, Suvan J, Moles DR, Laurell L, Tonetti MS. Adjunctive benefits of systemic amoxicillin and metronidazole in non-surgical treatment of generalized aggressive periodontitis: a randomized placebo-controlled clinical trial. J Clin Periodontol. 2005 Oct;32(10):1096-107. doi: 10.1111/j.1600-051X.2005.00814.x.

    PubMed 16174275

  • Mestnik MJ, Feres M, Figueiredo LC, Soares G, Teles RP, Fermiano D, Duarte PM, Faveri M. The effects of adjunctive metronidazole plus amoxicillin in the treatment of generalized aggressive periodontitis: a 1-year double-blinded, placebo-controlled, randomized clinical trial. J Clin Periodontol. 2012 Oct;39(10):955-61. doi: 10.1111/j.1600-051X.2012.01932.x. Epub 2012 Aug 6.

    PubMed 22882646

  • Mestnik MJ, Feres M, Figueiredo LC, Duarte PM, Lira EA, Faveri M. Short-term benefits of the adjunctive use of metronidazole plus amoxicillin in the microbial profile and in the clinical parameters of subjects with generalized aggressive periodontitis. J Clin Periodontol. 2010 Apr;37(4):353-65. doi: 10.1111/j.1600-051X.2010.01538.x.

    PubMed 20447259

  • Miranda TS, Feres M, Perez-Chaparro PJ, Faveri M, Figueiredo LC, Tamashiro NS, Bastos MF, Duarte PM. Metronidazole and amoxicillin as adjuncts to scaling and root planing for the treatment of type 2 diabetic subjects with periodontitis: 1-year outcomes of a randomized placebo-controlled clinical trial. J Clin Periodontol. 2014 Sep;41(9):890-9. doi: 10.1111/jcpe.12282. Epub 2014 Jul 17.

    PubMed 24930639

  • Rabelo CC, Feres M, Goncalves C, Figueiredo LC, Faveri M, Tu YK, Chambrone L. Systemic antibiotics in the treatment of aggressive periodontitis. A systematic review and a Bayesian Network meta-analysis. J Clin Periodontol. 2015 Jul;42(7):647-57. doi: 10.1111/jcpe.12427.

    PubMed 26087839

  • Sgolastra F, Gatto R, Petrucci A, Monaco A. Effectiveness of systemic amoxicillin/metronidazole as adjunctive therapy to scaling and root planing in the treatment of chronic periodontitis: a systematic review and meta-analysis. J Periodontol. 2012 Oct;83(10):1257-69. doi: 10.1902/jop.2012.110625. Epub 2012 Feb 14.

    PubMed 22220767

  • Sgolastra F, Petrucci A, Gatto R, Monaco A. Effectiveness of systemic amoxicillin/metronidazole as an adjunctive therapy to full-mouth scaling and root planing in the treatment of aggressive periodontitis: a systematic review and meta-analysis. J Periodontol. 2012 Jun;83(6):731-43. doi: 10.1902/jop.2011.110432. Epub 2011 Nov 3.

    PubMed 22050545

  • Silva MP, Feres M, Sirotto TA, Soares GM, Mendes JA, Faveri M, Figueiredo LC. Clinical and microbiological benefits of metronidazole alone or with amoxicillin as adjuncts in the treatment of chronic periodontitis: a randomized placebo-controlled clinical trial. J Clin Periodontol. 2011 Sep;38(9):828-37. doi: 10.1111/j.1600-051X.2011.01763.x. Epub 2011 Jul 15.

    PubMed 21762197

  • Zandbergen D, Slot DE, Niederman R, Van der Weijden FA. The concomitant administration of systemic amoxicillin and metronidazole compared to scaling and root planing alone in treating periodontitis: =a systematic review=. BMC Oral Health. 2016 Feb 29;16:27. doi: 10.1186/s12903-015-0123-6.

    PubMed 26928597

  • Zandbergen D, Slot DE, Cobb CM, Van der Weijden FA. The clinical effect of scaling and root planing and the concomitant administration of systemic amoxicillin and metronidazole: a systematic review. J Periodontol. 2013 Mar;84(3):332-51. doi: 10.1902/jop.2012.120040. Epub 2012 May 21.

    PubMed 22612369

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Scaling and root planing (SRP), Metronidazole 250 (7 days) and Metronidazole 400 (7 days) in people with Chronic Periodontitis, run by University of Guarulhos 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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 13 Jan 2020. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

Results are not available in the source record.

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?

Percentage of subjects reaching ≤ 4 periodontal sites with probing depth (PD) ≥ 5 mm at 12 months (time frame: 12 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 NCT02735395, which also lists 18 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 13 Jan 2020.

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