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| ID | Type | Description | Link |
|---|---|---|---|
| CBEIH-SIU 08-44-203 |
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| Name | Class |
|---|---|
| Universidad de Antioquia | OTHER |
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The purpose of this study is to assess the clinical and microbiological effectiveness of the moxifloxacin compared with the combination ciprofloxacin - metronidazole, when used as adjunctive therapy to scaling and root planning for the treatment of advanced chronic periodontitis.
Periodontitis is an endemic inflammatory disease caused by a mixed bacterial biofilm infection that is followed by destruction of tooth supporting tissues. Standard of care consists of lifelong mechanical removal of the biofilm. However, outcome is variable. According to recent EFP and AAP reviews, adjunctive antimicrobial therapy may be beneficial.However, bearing in mind that Colombia has reported the frequent presence of Enterobacteriaceae (Klebsiella and Enterobacter) in subgingival plaque of patients with chronic periodontitis, the response to treatment may be different.The enteric have shown resistance to amoxicillin, amoxicillin / clavulanate, metronidazole and tetracycline in studies conducted in the United States, Norway, Brazil and Colombia.Although the combination ciprofloxacin metronidazole has been recommended in the dental literature are not known publications that demonstrate its effectiveness against periodontopathogens and enteric present in subgingival plaque of subjects with chronic periodontitis.On the other hand, some in vitro studies have demonstrated the effectiveness of moxifloxacin against periodontopathogens, but was not aware of any clinical trials or in vitro studies on antibiotic resistance and susceptibility to enteric isolated subgingival plaque of patients with chronic periodontitis in which employs moxifloxacin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moxifloxacin | Experimental | Scaling and root planing plus 400 mg moxifloxacin once daily for 7 days. |
|
| Ciprofloxacin plus metronidazole | Active Comparator | Scaling and root planing plus ciprofloxacin 1000 mg once daily for 7 days and metronidazole 500 mg twice daily for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| moxifloxacin | Drug | 400 mg moxifloxacin once daily for 7 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Probing Depth | six months period (two measurements) |
| Measure | Description | Time Frame |
|---|---|---|
| Subjective perception of treatment outcome, attachment gain,bleeding on probing, and full mouth plaque score. | six months | |
| Microbial colonization dynamic | six months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carlos M Ardila, DDS Cand PhD | Grupo Epidemiologia Universidad de Antioquia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculta Nacional de Salud Publica Universidad de Antioquia | MedellÃn | Antioquia | 057-4 | Colombia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20151809 | Result | Ardila CM, Fernandez N, Guzman IC. Antimicrobial susceptibility of moxifloxacin against gram-negative enteric rods from colombian patients with chronic periodontitis. J Periodontol. 2010 Feb;81(2):292-9. doi: 10.1902/jop.2009.090464. | |
| 20383102 | Result | Ardila CM, Lopez MA, Guzman IC. High resistance against clindamycin, metronidazole and amoxicillin in Porphyromonas gingivalis and Aggregatibacter actinomycetemcomitans isolates of periodontal disease. Med Oral Patol Oral Cir Bucal. 2010 Nov 1;15(6):e947-51. |
| Label | URL |
|---|---|
| Clinical trial of moxifloxacin in chronic periodontitis | View source |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 25, 2014 | |
| Reset | May 22, 2014 | |
| Release | Aug 4, 2014 | |
| Reset | Aug 20, 2014 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 25, 2014 | May 22, 2014 | |||
| Aug 4, 2014 |
| ID | Term |
|---|---|
| D055113 | Chronic Periodontitis |
| ID | Term |
|---|---|
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D000077266 | Moxifloxacin |
| D002939 | Ciprofloxacin |
| D008795 | Metronidazole |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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| Ciprofloxacin plus metronidazole | Drug | Ciprofloxacin 1000 mg once daily for 7 days; Metronidazole 500 mg twice daily for 7 days |
|
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| 33197289 | Derived | 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. |
| Aug 20, 2014 |
| D002908 |
| Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009593 | Nitroimidazoles |
| D009574 | Nitro Compounds |
| D009930 | Organic Chemicals |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |