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This randomized clinical trial aimed to compare the clinical and microbiological effects of different times of administration of metronidazole (MTZ) and amoxicillin (AMX) in the treatment of periodontitis.
Scaling and root planing (SRP) is the most used periodontal therapy for periodontal treatment. Despite leading, in most cases, to an improvement in periodontal clinical parameters, SRP is often insufficient to profoundly modify the pathogenic bacterial profile to a profile related to periodontal health, especially in cases of more advanced and generalized diseases. Thus, other therapies supporting SRP, such as systemic antibiotics, have been proposed with the aim of enhancing the clinical and microbiological effects of this form of therapy. Studies have shown excellent clinical and microbiological results using the association of systemic antibiotics, especially the association of metronidazole (MTZ) and amoxicillin (AMX) in the treatment of severe periodontitis. However, some essential issues associated with the use of these antibiotics remain to be established. Therefore, the aim of this randomized clinical trial was to compare the clinical and microbiological effects of different times of administration of metronidazole (MTZ) and amoxicillin (AMX) in the treatment of periodontitis. Seventy-two subjects with severe periodontitis were selected and randomized into two groups (n = 36 / group) - Test 1 (T1): SRP in 14 days, associated with the concomitant use of AMX (500mg, 3x / day) and MTZ (400mg 3x / day) for 14 days; and Test 2 (T2): SRP in 14 days, associated with the use of AMX and MTZ immediately after the end of the SRP in the following 14 days. All volunteers received clinical and microbiological evaluation at baseline, 3, 6 and 12 months post-SRP. Subgingival biofilm samples were collected by subject and analyzed for counts and proportions of 40 bacterial species by checkerboard DNA-DNA hybridization. Differences in clinical and microbiological parameters between groups and over time were evaluated using the ANOVA, ANCOVA, Chi-square and Tukey tests. Microbiological analyzes were performed using adjustments for multiple comparisons. Statistical significance was set at 5%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test 1 | Experimental | Scaling and root planing + Metronidazole (400 mg/thrice a day,TID) and Amoxicillin (500 mg/ TID) for 14 days, starting with the first SRP session |
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| Test 2 | Experimental | Scaling and root planing (SRP) + Metronidazole (400 mg/thrice a day,TID) and Amoxicillin (500 mg/ TID) immediately after the end of the SRP in the following 14 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Scaling and root planing | Procedure | SRP will be 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects reaching ≤ 4 periodontal sites with probing depth (PD) ≥ 5 mm. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of sites with PD ≥ 5 mm. | Baseline, 3, 6 and 12 months. | |
| Number of sites with PD ≥ 6 mm. | Baseline, 3, 6 and 12 months. | |
| Number of sites with PD ≥ 7 mm. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marcelo Faveri, Professor | University of Guarulhos | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Guarulhos | Guarulhos | São Paulo | 07023-070 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29926490 | Background | Papapanou PN, Sanz M, Buduneli N, Dietrich T, Feres M, Fine DH, Flemmig TF, Garcia R, Giannobile WV, Graziani F, Greenwell H, Herrera D, Kao RT, Kebschull M, Kinane DF, Kirkwood KL, Kocher T, Kornman KS, Kumar PS, Loos BG, Machtei E, Meng H, Mombelli A, Needleman I, Offenbacher S, Seymour GJ, Teles R, Tonetti MS. Periodontitis: Consensus report of workgroup 2 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S162-S170. doi: 10.1111/jcpe.12946. | |
| 32224549 |
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| ID | Term |
|---|---|
| D010518 | Periodontitis |
| ID | Term |
|---|---|
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D014080 | Tooth Exfoliation |
| D016745 | Root Planing |
| ID | Term |
|---|---|
| D009063 | Dental Physiological Phenomena |
| D055688 | Digestive System and Oral Physiological Phenomena |
| D012534 | Dental Scaling |
| D003777 | Dental Prophylaxis |
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|
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| Placebos during SRP | Drug | Amoxicillin and metronidazole placebos thrice a day for 14 days, beginning with the first SRP session. |
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| Placebos after SRP | Drug | Amoxicillin and metronidazole placebos thrice a day for 14 days, beginning after the last SRP session. |
|
| Metronidazole during SRP | Drug | Metronidazole 400 mg, thrice a day for 14 days, beginning with the first SRP session. |
|
| Amoxicillin during SRP | Drug | Amoxicillin 500 mg, thrice a day for 14 days, beginning with the first SRP session. |
|
| Metronidazole after SRP | Drug | Metronidazole 400 mg, thrice a day for 14 days, beginning after the last SRP session. |
|
| Amoxicillin after SRP | Drug | Amoxicillin 500 mg, thrice a day for 14 days, beginning after the last SRP session. |
|
| Baseline, 3, 6 and 12 months. |
| Reduction in the number of sites with PD ≥ 5 mm. | Baseline, 3, 6 and 12 months. |
| Reduction in the number of sites with PD ≥ 6 mm. | Baseline, 3, 6 and 12 months. |
| Reduction in the number of sites with PD ≥ 7 mm. | Baseline, 3, 6 and 12 months. |
| Mean PD changes in sites with initial PD between 4-6 mm | Baseline - 12 months. |
| Mean PD changes in sites with initial PD ≥ 7 mm. | Baseline - 12 months. |
| Mean CAL changes in sites with initial CAL between 4-6 mm , | Baseline - 12 months. |
| Mean CAL changes in sites with initial CAL ≥ 7 mm. | Baseline - 12 months. |
| Full-mouth PD. | Baseline, 3, 6 and 12 months. |
| Full-mouth clinical attachment level. | Baseline, 3, 6 and 12 months. |
| Percentage of sites with bleeding on probing. | Baseline, 3, 6 and 12 months. |
| Percentage of sites with plaque accumulation. | Baseline, 3, 6 and 12 months. |
| Percentage of sites with marginal bleeding. | Baseline, 3, 6 and 12 months. |
| Occurrence of headache obtained through a questionnaire of adverse effects. | 14 days after taking antibiotic. |
| Occurrence of vomiting obtained through a questionnaire of adverse effects. | 14 days after taking antibiotic. |
| Occurrence of diarrhea obtained through a questionnaire of adverse effects. | 14 days after taking antibiotic. |
| Occurrence of metallic taste obtained through a questionnaire of adverse effects. | 14 days after taking antibiotic. |
| Occurrence of nausea obtained through a questionnaire of adverse effects. | 14 days after taking antibiotic. |
| Occurrence of irritability obtained through a questionnaire of adverse effects. | 14 days after taking antibiotic. |
| Proportions of periodontal pathogenic bacterial species. | Baseline, 3, 6 and 12 months. |
| Counts of periodontal pathogenic bacterial species. | Baseline, 3, 6 and 12 months. |
| Background |
| Feres M, Retamal-Valdes B, Faveri M, Duarte P, Shibli J, Soares GMS, Miranda T, Teles F, Goodson M, Hasturk H, Van Dyke T, Ehmke B, Eickholz P, Schlagenhauf U, Meyle J, Koch R, Kocher T, Hoffmann T, Kim TS, Kaner D, Figueiredo LC, Doyle H. Proposal of a Clinical Endpoint for Periodontal Trials: The Treat-to-Target Approach. J Int Acad Periodontol. 2020 Apr 1;22(2):41-53. |
| 25494600 | Result | 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. |
| 23016867 | Result | 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. |
| 24834504 | Result | 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. |
| 24913531 | Result | Faveri M, Figueiredo LC, Feres M. Treatment of chronic periodontitis may be improved by the adjunctive use of systemic metronidazole. J Evid Based Dent Pract. 2014 Jun;14(2):70-2. doi: 10.1016/j.jebdp.2014.04.025. Epub 2014 Apr 12. No abstract available. |
| 25764587 | Result | Feres M, Faveri M, Figueiredo LC, Teles R, Flemmig T, Williams R, Lang NP. Group B. Initiator paper. Non-surgical periodontal therapy: mechanical debridement, antimicrobial agents and other modalities. J Int Acad Periodontol. 2015 Jan;17(1 Suppl):21-30. No abstract available. |
| 28303587 | Result | 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. |
| 31994207 | Result | Teughels W, Feres M, Oud V, Martin C, Matesanz P, Herrera D. Adjunctive effect of systemic antimicrobials in periodontitis therapy: A systematic review and meta-analysis. J Clin Periodontol. 2020 Jul;47 Suppl 22:257-281. doi: 10.1111/jcpe.13264. |
| 32844406 | Result | Feres M, Retamal-Valdes B, Fermiano D, Faveri M, Figueiredo LC, Mayer MPA, Lee JJ, Bittinger K, Teles F. Microbiome changes in young periodontitis patients treated with adjunctive metronidazole and amoxicillin. J Periodontol. 2021 Apr;92(4):467-478. doi: 10.1002/JPER.20-0128. Epub 2020 Oct 12. |
| D010517 | Periodontics |
| D003813 | Dentistry |
| D013357 | Subgingival Curettage |
| D011313 | Preventive Dentistry |