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PeriodontitisPhase 4NCT02135952

Metronidazole and Amoxicillin for the Treatment of Type 2 Diabetic Subjects With Periodontitis

A Phase 4 study testing SRP and MTZ+AMX in people with 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Diabetes mellitus (DM) is a widely prevalent disease associated with several major systemic and oral complications, such as periodontitis. The use of adjunctive local and/or systemic antimicrobials has been proposed to improve the clinical and glycemic outcomes of the scaling and root planing (SRP) in diabetic… Read more about this study

Who is it for?
Ages 35 years and older
Conditions the study is for
Periodontitis
What is being tested?
SRP and MTZ+AMX
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
58 participants
Where
1 siteBrazil
Study dates
Sep 2011to Oct 2014
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 35 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 35 years of age
  • Diagnosis of type 2 DM for ≥ 5 years
  • DM treatment with diet and insulin supplementation or oral hypoglycemic agents
  • Glycated hemoglobin (HbA1c) levels ≥ 6.5% ≤ 11%
  • At least 15 teeth
  • More than 30% of the sites with probing depth (PD) and clinical attachment level (CAL) ≥ 4 mm
  • Minimum of six teeth with at least one site with PD and CAL ≥ 5 mm and bleeding on probing (BoP) at baseline.

Who cannot join

  • Pregnancy
  • Lactation
  • Current smoking
  • Smoking within the past 5 years
  • Scaling and root planing (SRP) in the previous 12 months
  • Antimicrobial therapies during the previous 6 months
Show all 16Show fewer
  • Medical conditions requiring prophylactic antibiotic coverage
  • Continuous use of mouthrinses containing antimicrobials in the preceding 3 months
  • Systemic conditions (except DM) that could affect the progression of periodontitis (e.g. immunological disorders, osteoporosis)
  • Long-term administration of anti-inflammatory
  • Long-term administration of immunosuppressive medications
  • Allergy to metronidazole and/or amoxicillin
  • Presence of periapical pathology
  • Use of orthodontic appliances
  • Presence of extensive prosthetic rehabilitation
  • Major complications of DM (i.e. cardiovascular and peripheral vascular diseases [ulcers, gangrene and amputation], neuropathy and nephropathy)

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • University of Guarulhos

    Guarulhos, São Paulo, 07023-070

Other trials in Brazil

About this study

Official title: Metronidazole and Amoxicillin as Adjuncts to Scaling and Root Planing for the Treatment of Type 2 Diabetic Subjects With Periodontitis: a Randomized Placebo-controlled Clinical Trial

Diabetes mellitus (DM) is a widely prevalent disease associated with several major systemic and oral complications, such as periodontitis. The use of adjunctive local and/or systemic antimicrobials has been proposed to improve the clinical and glycemic outcomes of the scaling and root planing (SRP) in diabetic subjects. The combination of metronidazole (MTZ) and amoxicillin (AMX) has been largely recognized as an effective therapy for improving the clinical and microbiological outcomes of SRP in the treatment of with chronic periodontitis (ChP). However, no previous clinical trials to date have evaluated the effects of this antibiotic combination in the treatment of diabetic subjects with periodontitis. Therefore, the aim of this randomized clinical trial (RCT) will be to evaluate the clinical and microbiological effects of the use of MTZ+AMX as adjuncts to SRP for the treatment of type 2 diabetic subjects with generalized ChP.

Conditions
Periodontitis
Being tested
SRP, Placebo, MTZ+AMX
Keywords
Periodontitis, Diabetes
Medical subject headings
Periodontitis, Diabetes Mellitus

What participants receive

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

  • SRPProcedure or surgery

    SRP in four to six appointments lasting approximately 1 h each, using manual curettes and ultrasonic device under local anesthesia.

  • PlaceboOther

    Administration of placebo for 14 days started immediately after the first session of SRP.

  • MTZ+AMXDrug

    Administration of antibiotics (metronidazole and amoxicillin) for 14 days started immediately after the first session of SRP.

Study groups in NCT02135952
Study groupRoleWhat they receive
SRP+MTZ+AMXActive comparatorScaling and root planing (SRP) + metronidazole (MTZ; 400 mg thrice a day [TID] for 14 days) + amoxicillin (AMX; 500 mg TID for 14 days)
Receives: Procedure: SRP; Drug: MTZ+AMX
SRP+placeboPlacebo comparatorScaling and root planing + placebo
Receives: Procedure: SRP; Other: Placebo

What is being measured

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

  1. Changes in number of sites with probing depth (PD) ≥5 mm post-treatment

    Measured: From baseline to 12 months

Secondary outcomes (13)

  1. PD and clinical attachment level (CAL) changes at initially moderate sites

    Measured: From baseline to 12 months and from baseline to 24 months

  2. PD and CAL changes at initially deep sites

    Measured: From baseline to 12 months and from baseline to 24 months

  3. Changes in number of sites with PD ≥5mm

    Measured: From baseline to 12 months and from baseline to 24 months

  4. Full-mouth PD and CAL

    Measured: Baseline, 3, 6, 12 and 24 months

  5. Full-mouth percentages of sites with plaque

    Measured: Baseline, 3, 6, 12 and 24 months

  6. Full-mouth percentages of sites with marginal bleeding

    Measured: Baseline, 3, 6, 12 and 24 months

  7. Full-mouth percentages of sites with bleeding on probing

    Measured: Baseline, 3, 6, 12 and 24 months

  8. Full-mouth percentages of sites with suppuration

    Measured: Baseline, 3, 6, 12 and 24 months

  9. Full-mouth percentages of sites with PD ≥5mm

    Measured: Baseline, 3, 6,12 and 24 months

  10. Serum levels of glycated hemoglobin (HbA1c)

    Measured: Baseline, 3, 6, 12 and 24 months

  11. Serum levels of fasting plasma glucose FPG

    Measured: Baseline, 3, 6, 12 and 24 months

  12. Levels of periodontal pathogenic bacterial species

    Measured: Baseline, 3, 6, 12 and 24 months

  13. Occurrence of adverse events

    Measured: 14 days

Timeline

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

  1. First posted12 May 2014 (estimated)
  2. Study startSep 2011
  3. Primary completionOct 2014 (estimated)
  4. Study completionOct 2014 (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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02135952
Sponsor's protocol ID
SISNEP/697
Other IDs
2013/01072-5
Status last verified
May 2014
First submitted
5 May 2014
Last updated
12 May 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Amid R, Tabeie MB, Kadkhodazadeh M, Mehdizadeh AR, Youssefi N. Local concentration of systemic amoxicillin and metronidazole in healthy and inflamed gingiva: a comparative in vivo study. Drug Metabol Drug Interact. 2012 May 10;27(2):113-8. doi: 10.1515/dmdi-2012-0003.

    PubMed 22706234

  • Borgnakke WS, Ylostalo PV, Taylor GW, Genco RJ. Effect of periodontal disease on diabetes: systematic review of epidemiologic observational evidence. J Clin Periodontol. 2013 Apr;40 Suppl 14:S135-52. doi: 10.1111/jcpe.12080.

    PubMed 23627324

  • 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

  • Cionca N, Giannopoulou C, Ugolotti G, Mombelli A. Microbiologic testing and outcomes of full-mouth scaling and root planing with or without amoxicillin/metronidazole in chronic periodontitis. J Periodontol. 2010 Jan;81(1):15-23. doi: 10.1902/jop.2009.090390.

    PubMed 20059413

  • Feres M. Antibiotics in the treatment of periodontal diseases: microbiological basis and clinical applications. Ann R Australas Coll Dent Surg. 2008 Jun;19:37-44.

    PubMed 19728628

  • 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

  • Grossi SG, Skrepcinski FB, DeCaro T, Robertson DC, Ho AW, Dunford RG, Genco RJ. Treatment of periodontal disease in diabetics reduces glycated hemoglobin. J Periodontol. 1997 Aug;68(8):713-9. doi: 10.1902/jop.1997.68.8.713.

    PubMed 9287060

  • Jimenez M, Hu FB, Marino M, Li Y, Joshipura KJ. Type 2 diabetes mellitus and 20 year incidence of periodontitis and tooth loss. Diabetes Res Clin Pract. 2012 Dec;98(3):494-500. doi: 10.1016/j.diabres.2012.09.039. Epub 2012 Oct 3.

    PubMed 23040240

  • Lang NP, Tonetti MS. Periodontal risk assessment (PRA) for patients in supportive periodontal therapy (SPT). Oral Health Prev Dent. 2003;1(1):7-16.

    PubMed 15643744

  • 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, 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

  • Tamashiro NS, Duarte PM, Miranda TS, Maciel SS, Figueiredo LC, Faveri M, Feres M. Amoxicillin Plus Metronidazole Therapy for Patients with Periodontitis and Type 2 Diabetes: A 2-year Randomized Controlled Trial. J Dent Res. 2016 Jul;95(7):829-36. doi: 10.1177/0022034516639274. Epub 2016 Mar 24.

    PubMed 27013640

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing SRP and MTZ+AMX in people with 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 7 inclusion and 16 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 12 May 2014. 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?

Changes in number of sites with probing depth (PD) ≥5 mm post-treatment (time frame: From baseline to 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 NCT02135952, which also lists 12 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 12 May 2014.

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