Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2026-01-28 @ 10:43 AM
Study NCT ID:
NCT02735395
Status:
UNKNOWN
Last Update Posted:
2020-01-13
First Post:
2016-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dose and Duration of Metronidazole and Amoxicillin for Treatment of Chronic Periodontitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055113', 'term': 'Chronic Periodontitis'}, {'id': 'D010510', 'term': 'Periodontal Diseases'}], 'ancestors': [{'id': 'D010518', 'term': 'Periodontitis'}, {'id': 'D009059', 'term': 'Mouth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014080', 'term': 'Tooth Exfoliation'}, {'id': 'D016745', 'term': 'Root Planing'}, {'id': 'D000658', 'term': 'Amoxicillin'}], 'ancestors': [{'id': 'D009063', 'term': 'Dental Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}, {'id': 'D012534', 'term': 'Dental Scaling'}, {'id': 'D003777', 'term': 'Dental Prophylaxis'}, {'id': 'D010517', 'term': 'Periodontics'}, {'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D013357', 'term': 'Subgingival Curettage'}, {'id': 'D011313', 'term': 'Preventive Dentistry'}, {'id': 'D000667', 'term': 'Ampicillin'}, {'id': 'D010400', 'term': 'Penicillin G'}, {'id': 'D010406', 'term': 'Penicillins'}, {'id': 'D047090', 'term': 'beta-Lactams'}, {'id': 'D007769', 'term': 'Lactams'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-08', 'studyFirstSubmitDate': '2016-03-22', 'studyFirstSubmitQcDate': '2016-04-06', 'lastUpdatePostDateStruct': {'date': '2020-01-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-04-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of subjects reaching ≤ 4 periodontal sites with probing depth (PD) ≥ 5 mm at 12 months', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Number of sites with PD ≥ 5 mm', 'timeFrame': 'Baseline, 3, 6 and 12 months'}, {'measure': 'Number of sites with PD ≥ 6 mm', 'timeFrame': 'Baseline, 3, 6 and 12 months'}, {'measure': 'Number of sites with PD ≥ 7 mm', 'timeFrame': 'Baseline, 3, 6 and 12 months'}, {'measure': 'Reduction in the number of sites with PD ≥ 5 mm', 'timeFrame': 'Baseline, 3, 6 and 12 months'}, {'measure': 'Reduction in the number of sites with PD ≥ 6 mm', 'timeFrame': 'Baseline, 3, 6 and 12 months'}, {'measure': 'Reduction in the number of sites with PD ≥ 7 mm', 'timeFrame': 'Baseline, 3, 6 and 12 months'}, {'measure': 'Full-mouth PD', 'timeFrame': 'Baseline, 3, 6 and 12 months'}, {'measure': 'Full-mouth clinical attachment level', 'timeFrame': 'Baseline, 3, 6 and 12 months'}, {'measure': 'Percentage of sites with bleeding on probing', 'timeFrame': 'Baseline, 3, 6 and 12 months'}, {'measure': 'Percentage of sites with plaque accumulation', 'timeFrame': 'Baseline, 3, 6 and 12 months'}, {'measure': 'Percentage of sites with marginal bleeding', 'timeFrame': 'Baseline, 3, 6 and 12 months'}, {'measure': 'Occurrence of headache obtained through a questionnaire of adverse effects', 'timeFrame': '14 days after the beginning of treatments'}, {'measure': 'Occurrence of vomiting obtained through a questionnaire of adverse effects', 'timeFrame': '14 days after the beginning of treatments'}, {'measure': 'Occurrence of diarrhea obtained through a questionnaire of adverse effects', 'timeFrame': '14 days after the beginning of treatments'}, {'measure': 'Occurrence of metallic taste obtained through a questionnaire of adverse effects', 'timeFrame': '14 days after the beginning of treatments'}, {'measure': 'Occurrence of nausea obtained through a questionnaire of adverse effects', 'timeFrame': '14 days after the beginning of treatments'}, {'measure': 'Occurrence of irritability obtained through a questionnaire of adverse effects', 'timeFrame': '14 days after the beginning of treatments'}, {'measure': 'Proportions of periodontal pathogenic bacterial species', 'timeFrame': 'Baseline, 3, 6 and 12 months'}, {'measure': 'Counts of periodontal pathogenic bacterial species', 'timeFrame': 'Baseline, 3, 6 and 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Periodontal Diseases', 'Metronidazole', 'Amoxicillin', 'Chronic periodontitis', 'Root Planing'], 'conditions': ['Chronic Periodontitis']}, 'referencesModule': {'references': [{'pmid': '22220822', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '15560807', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '19254119', 'type': 'BACKGROUND', '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.'}, {'pmid': '25494600', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23016867', 'type': 'BACKGROUND', '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.'}, {'pmid': '16174275', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22882646', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '20447259', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24930639', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '26087839', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22220767', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22050545', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '21762197', 'type': 'BACKGROUND', '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.'}, {'pmid': '26928597', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22612369', 'type': 'BACKGROUND', '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.'}, {'pmid': '24834504', 'type': 'BACKGROUND', 'citation': 'Soares GM, Mendes JA, Silva MP, Faveri M, Teles R, Socransky SS, Wang X, Figueiredo LC, Feres M. Metronidazole alone or with amoxicillin as adjuncts to non-surgical treatment of chronic periodontitis: a secondary analysis of microbiological results from a randomized clinical trial. J Clin Periodontol. 2014 Apr;41(4):366-76. doi: 10.1111/jcpe.12217.'}, {'pmid': '33197289', 'type': 'DERIVED', 'citation': 'Khattri S, Kumbargere Nagraj S, Arora A, Eachempati P, Kusum CK, Bhat KG, Johnson TM, Lodi G. Adjunctive systemic antimicrobials for the non-surgical treatment of periodontitis. Cochrane Database Syst Rev. 2020 Nov 16;11(11):CD012568. doi: 10.1002/14651858.CD012568.pub2.'}, {'pmid': '28303587', 'type': 'DERIVED', 'citation': 'Borges I, Faveri M, Figueiredo LC, Duarte PM, Retamal-Valdes B, Montenegro SCL, Feres M. Different antibiotic protocols in the treatment of severe chronic periodontitis: A 1-year randomized trial. J Clin Periodontol. 2017 Aug;44(8):822-832. doi: 10.1111/jcpe.12721. Epub 2017 Jul 26.'}]}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥30 years of age;\n* at least 15 teeth (excluding third molars and teeth with advanced decay indicated for extraction)\n* a minimum of 6 teeth with at least one site each with probing depth (PD) and clinical \\* attachment level (CAL) ≥5 mm;\n* at least 30% of the sites with PD and CAL ≥4 mm and bleeding on probing (BOP).\n\nExclusion Criteria:\n\n* pregnancy\n* breastfeeding\n* current smoking and former smoking within the past 5 years;\n* systemic diseases that could affect the progression of periodontitis (e.g. diabetes, immunological disorders, osteoporosis);\n* scaling and root planing an in the previous 12 months;\n* antibiotic therapy in the previous 6 months;\n* long-term intake of anti-inflammatory medications;\n* need for antibiotic pre-medication for routine dental therapy;\n* allergy to metronidazole and/or amoxicillin.'}, 'identificationModule': {'nctId': 'NCT02735395', 'briefTitle': 'Dose and Duration of Metronidazole and Amoxicillin for Treatment of Chronic Periodontitis', 'organization': {'class': 'OTHER', 'fullName': 'University of Guarulhos'}, 'officialTitle': 'Impact of Different Dosages and Time of Administration of Metronidazole and Amoxicillin in the Treatment of Generalized Chronic Periodontitis: A Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'SISNEP/513'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Scaling and root planing (SRP) + two placebo pills thrice a day (TID) for 14 days (control group)', 'interventionNames': ['Procedure: Scaling and root planing (SRP)', 'Other: Placebo 400 (14 days)', 'Other: Placebo 500']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MTZ 250 (7 days)', 'description': 'SRP + MTZ (250mg/TID) + AMX, for 7 days and placebos for another 7 days', 'interventionNames': ['Procedure: Scaling and root planing (SRP)', 'Drug: Metronidazole 250 (7 days)', 'Drug: Amoxicillin', 'Other: Placebo 250 (7 days)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MTZ 400 (7 days)', 'description': 'SRP + MTZ (400mg/TID) + AMX, for 7 days and placebos for another 7 days', 'interventionNames': ['Procedure: Scaling and root planing (SRP)', 'Drug: Metronidazole 400 (7 days)', 'Drug: Amoxicillin', 'Other: Placebo 400 (7 days)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MTZ 250 (14 days)', 'description': 'SRP +MTZ (250mg/TID) + AMX for 14 days', 'interventionNames': ['Procedure: Scaling and root planing (SRP)', 'Drug: Metronidazole 250 (14 days)', 'Drug: Amoxicillin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MTZ 400 (14 days)', 'description': 'SRP +MTZ (400mg/TID) + AMX for 14 days', 'interventionNames': ['Procedure: Scaling and root planing (SRP)', 'Drug: Metronidazole 400 (14 days)', 'Drug: Amoxicillin']}], 'interventions': [{'name': 'Scaling and root planing (SRP)', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Control', 'MTZ 250 (14 days)', 'MTZ 250 (7 days)', 'MTZ 400 (14 days)', 'MTZ 400 (7 days)']}, {'name': 'Metronidazole 250 (7 days)', 'type': 'DRUG', 'description': 'Subjects will intake Metronidazole 250 mg. for 7 days, starting immediately after the first session of Scaling and Root Planing.', 'armGroupLabels': ['MTZ 250 (7 days)']}, {'name': 'Metronidazole 400 (7 days)', 'type': 'DRUG', 'description': 'Subjects will intake Metronidazole 400 mg. for 7 days, starting immediately after the first session of Scaling and Root Planing.', 'armGroupLabels': ['MTZ 400 (7 days)']}, {'name': 'Metronidazole 250 (14 days)', 'type': 'DRUG', 'description': 'Subjects will intake Metronidazole 250 mg. for 14 days, starting immediately after the first session of Scaling and Root Planing.', 'armGroupLabels': ['MTZ 250 (14 days)']}, {'name': 'Metronidazole 400 (14 days)', 'type': 'DRUG', 'description': 'Subjects will intake Metronidazole 400 mg. for 14 days, starting immediately after the first session of Scaling and Root Planing.', 'armGroupLabels': ['MTZ 400 (14 days)']}, {'name': 'Amoxicillin', 'type': 'DRUG', 'description': 'Subjects will intake Amoxicillin 500 mg. for 14 days, starting immediately after and the first session of Scaling and Root Planing.', 'armGroupLabels': ['MTZ 250 (14 days)', 'MTZ 250 (7 days)', 'MTZ 400 (14 days)', 'MTZ 400 (7 days)']}, {'name': 'Placebo 250 (7 days)', 'type': 'OTHER', 'description': 'Subjects will intake placebo of Metronidazole 250 mg. for 7 days, starting immediately after to intake Metronidazole 250 mg.', 'armGroupLabels': ['MTZ 250 (7 days)']}, {'name': 'Placebo 400 (7 days)', 'type': 'OTHER', 'description': 'Subjects will intake placebo of Metronidazole 400 mg. for 7 days, starting immediately after to intake Metronidazole 400 mg.', 'armGroupLabels': ['MTZ 400 (7 days)']}, {'name': 'Placebo 400 (14 days)', 'type': 'OTHER', 'description': 'Subjects will intake placebo of Metronidazole 400 mg. for 14 days, starting immediately after the first session of Scaling and Root Planing.', 'armGroupLabels': ['Control']}, {'name': 'Placebo 500', 'type': 'OTHER', 'description': 'Subjects will intake placebo of Amoxicillin 500 mg. for 14 days, starting immediately after the first session of Scaling and Root Planing.', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07023-070', 'city': 'Guarulhos', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Guarulhos University', 'geoPoint': {'lat': -23.46278, 'lon': -46.53333}}], 'overallOfficials': [{'name': 'Magda Feres, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Guarulhos University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Guarulhos', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'DDS, MSc, PhD Student', 'investigatorFullName': 'Belén Retamal-Valdes', 'investigatorAffiliation': 'University of Guarulhos'}}}}