Sponsor study identifier
interventional
64
1 country
1
Study Start
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2012
Actual (reported)Study Completion
Not reported
Date not reportedRandomized controlled clinical trials have demonstrated that the use of amoxicillin (AMX) and metronidazole (MTZ) as adjuncts to mechanical therapy improves the clinical and microbiological outcomes of scaling and root planing (SRP) in non-smokers and smokers with ChP. However, the effects of this antibiotic protocol have not been directly compared in non-smokers and smokers. Therefore, the aim of this study will be to compare the clinical and microbiological effects of the adjunctive use of MTZ+AMX to SRP in smokers and non-smokers subjects with chronic periodontitis (ChP). It was hypothesized that non-smokers would benefit better from this combination of therapies than the smokers.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
December 2012
Actual (reported)April 15, 2013
Actual (reported)April 23, 2013
Actual (reported)Mean clinical attachment level change post- scaling and root planing in sites with initial probing depth ≥ 7 mm
At 3, 6 and 12 months post-therapy.
Number of subjects with low, moderate and high risk for disease progression.
At 3, 6 and 12 months post-therapy
Mean full-mouth clinical attachment level.
Baseline and at 3, 6 and 12 months post-therapy
Mean full-mouth probing depth.
Baseline and at 3, 6 and 12 months post-therapy.
Mean clinical attachment level change post-scaling and root planing in sites with initial probing depth between 4-6 mm
At 3, 6 and 12 months post-therapy
Mean probing depth reduction post-scaling and root planing in sites with initial probing depth between 4-6 mm
At 3, 6 and 12 months post-therapy.
Metronidazole plus Amoxicillin
Metronidazole plus Amoxicillin
All subjects will receive scaling and root planing combined with systemic metronidazole (400 mg) and amoxicillin (500 mg). Both antibiotics were administered T.I.D. for 14 days.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Metronidazole plus Amoxicillin
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordUniversity of Guarulhos
Guarulhos, São Paulo/ SP, 07023-070, Brazil
Marcelo Faveri, DDS, PhD.
University of Guarulhos
Magda Feres, DDS, PhD.
University of Guarulhos
Luciene C Figueiredo, DDS, PhD.
University of Guarulhos
64 participants (actual enrollment reported by the registry).
First Submitted
April 15, 2013
First Posted
April 23, 2013
Study Start
July 2011
Date type not reportedThis date has not been verified as actual or estimated.
Role of Herbal Immunomodulators in the Treatment of Chronic Periodontitis
Contact the study team to confirm eligibility.
Primary Completion
December 2012
Actual (reported)Last Updated
April 23, 2013
Record last verified: 2013-04
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Source: ClinicalTrials.gov.
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