Changes in Resistome After Dental Extraction and Amoxicillin.
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|ClinicalTrials.gov Identifier: NCT02830347|
Recruitment Status : Unknown
Verified July 2016 by Dr Michael G. Botelho, The University of Hong Kong.
Recruitment status was: Active, not recruiting
First Posted : July 12, 2016
Last Update Posted : October 27, 2017
The aim of this study is to evaluate the nature of the change in oral and gut bacterial resistance profiles after antibiotic therapy for a surgical procedure in two groups. The intervention group will receive a course of amoxicillin and analgesics after surgical extraction and have bacterial samples taken from saliva, tongue coatings and stool samples at four appointments over a period of six months. This will be compared to the control group which receive only analgesics after the surgical extraction.
An examination of the development and sustainability of antibiotic resistance in the oral and gut microbiome of healthy cohorts will be followed up for 6 months, after surgical extraction of impacted teeth.
Change in proportion of antibiotic resistant bacterial components will be studied using Metagenomic DNA sequencing and quantification of resistant genes .
|Condition or disease||Intervention/treatment|
|Impacted Third Molar Tooth||Drug: Amoxicillin Procedure: Extraction|
|Study Type :||Observational|
|Estimated Enrollment :||16 participants|
|Official Title:||Evaluation of the Changes in Oral and Gut Bacterial Resistance Caused by Short Term Antibiotic Treatment Following a Surgical Dental Procedure - A Prospective Clinical Study.|
|Study Start Date :||June 2015|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||March 2018|
No randomization is performed. Patients who are prescribed antibiotics by the clinician performing the tooth extraction ( based on case complexity and intra operative judgement) are recruited into this group.The principal investigator is not involved in the decision to prescribe antibiotics or not.
Other Name: Aroxin
Extraction of third molars
Patients who do not receive antibiotics after extractions are recruited into this group.
Extraction of third molars
- Quantification of antibiotic resistance genes by Resistance genes output at each timepoint from HUmanN 1.0 .Validation by QPCR values for Blatem and erm genes at each timepoint. [ Time Frame: Baseline,One week,One month,Six months ]
Resistome analysis Changes in the (relative) concentration of total resistance genes (the resistome) in the metagenomic DNA sequences will be analyzed as follows: Antibiotic resistance genes will be downloaded from the Antibiotic Resistance Genes Database (20). The downloaded dataset (ardbAnno1.0), containing 7828 entries, will be made non-redundant first and UBLAST from USEARCH v7.0.1090 (20) will be used to map the reads to the (ARDB) proteins (E-value threshold 10, post-filtered to include hits with a maximum E-value of 1E-10 inclusive).
The results will be processed with HUMAN (21) to assign weights to the proteins. These weights were then normalized by dividing by the total number of filtered (non-human) reads, and summarized per antibiotic resistance type in the resistome. Next, fold changes will calculated for all resistance types with a baseline weight larger than 1E-8.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02830347
|Oral Rehabilitation, Faculty of Dentistry, The University of Hong Kong|
|Hong Kong, China|
|Principal Investigator:||Michael G Botelho, BDS MSc PhD||The University of Hong Kong|