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

Periodontitis Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02135952
• Other study ID #: SISNEP/697
• Secondary ID: 2013/01072-5
• Status: Active, not recruiting
• Phase: Phase 4
• First received: May 5, 2014
• Last updated: May 6, 2014
• Start date: September 2011
• Est. completion date: October 2014

Study information

• Verified date: May 2014
• Source: University of Guarulhos
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical 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 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 58
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

Inclusion Criteria:

• = 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.

Exclusion Criteria:

• 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

• 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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Periodontitis

Intervention

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

Other:
• Placebo
Administration of placebo for 14 days started immediately after the first session of SRP.

Drug:
• MTZ+AMX
Administration of antibiotics (metronidazole and amoxicillin) for 14 days started immediately after the first session of SRP.

Locations

Country	Name	City	State
Brazil	University of Guarulhos	Guarulhos	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Guarulhos

Country where clinical trial is conducted

Brazil, 

References & Publications (11)

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. — View Citation

Borgnakke WS, Ylöstalo 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. — View Citation

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 . — View Citation

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. Review. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in number of sites with probing depth (PD) =5 mm post-treatment		From baseline to 12 months	Yes
Secondary	PD and clinical attachment level (CAL) changes at initially moderate sites		From baseline to 12 months and from baseline to 24 months	Yes
Secondary	PD and CAL changes at initially deep sites		From baseline to 12 months and from baseline to 24 months	Yes
Secondary	Changes in number of sites with PD =5mm		From baseline to 12 months and from baseline to 24 months	Yes
Secondary	Full-mouth PD and CAL		Baseline, 3, 6, 12 and 24 months	Yes
Secondary	Full-mouth percentages of sites with plaque		Baseline, 3, 6, 12 and 24 months	Yes
Secondary	Full-mouth percentages of sites with marginal bleeding		Baseline, 3, 6, 12 and 24 months	Yes
Secondary	Full-mouth percentages of sites with bleeding on probing		Baseline, 3, 6, 12 and 24 months	Yes
Secondary	Full-mouth percentages of sites with suppuration		Baseline, 3, 6, 12 and 24 months	Yes
Secondary	Full-mouth percentages of sites with PD =5mm		Baseline, 3, 6,12 and 24 months	Yes
Secondary	Serum levels of glycated hemoglobin (HbA1c)		Baseline, 3, 6, 12 and 24 months	Yes
Secondary	Serum levels of fasting plasma glucose FPG		Baseline, 3, 6, 12 and 24 months	Yes
Secondary	Levels of periodontal pathogenic bacterial species		Baseline, 3, 6, 12 and 24 months	Yes
Secondary	Occurrence of adverse events		14 days	Yes