Changes in Resistome After Dental Extraction and Amoxicillin.

NCT02830347 | Unknown DMC

• 1 other identifier: Version 1.1 (22.4.15)
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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 .

Conditions

Impacted Third Molar Tooth

Keywords

antibiotic resistance; oral microbiome

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  Baseline,One week,One month,Six months

Study Arms (2)

Amoxicillin

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.

Drug: Amoxicillin; Procedure: Extraction

No Amoxicillin

Patients who do not receive antibiotics after extractions are recruited into this group.

Procedure: Extraction

Interventions

Amoxicillin DRUG

Extraction

Also known as: Aroxin

Amoxicillin

Extraction PROCEDURE

Extraction of third molars

Amoxicillin; No Amoxicillin

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be recruited from the waiting list from the Prince Philip Dental Hospital, Subjects scheduled for third molar extraction will be recruited based on the inclusion and exclusion criteria, provided they give a written informed consent for the acquisition of Saliva, tongue coatings and stool samples at the specified time points, after the study design and objectives have been explained in detail by the investigator. The prescription of antibiotics will be based on clinical judgment based on case complexity and the extent of the surgical trauma intra-operative Group 1- Surgical extraction with antibiotics-Amoxicillin 250 mg three times daily for 5 days and analgesics for pain relief. Group 2- Surgical extraction without antibiotics- Only analgesics for pain relief

You may qualify if:

• Men and women aged between 18 and 45 years
• Subjects who are scheduled to have a surgical tooth extraction.
• Subjects who have signed an informed consent after being informed of the study design, objectives and, risks/benefits
• No history of use of antibiotics up to three months prior to participation in the study.
• No medical condition that prevents the surgical procedure or antibiotic therapy.
• No history of hypersensitivity to beta lactams.
• No contraindication to amoxicillin therapy.
• Subjects are not pregnant or currently breast feeding.
• No known or suspected immunodeficiency.

You may not qualify if:

• History of antibiotic use within 3 months from baseline evaluation.
• Any medical condition that prevents the surgical procedure or antibiotic therapy.
• History of hypersensitivity to beta lactams
• Contraindication for amoxicillin therapy
• Pregnant or breast feeding women.
• Subjects with known or suspected immunodeficiency.
• Caries active subjects defined as subjects with active caries involving more than 3 teeth.
• Subjects diagnosed with chronic periodontitis.
• Subjects regularly using an antibacterial mouth rinse or planning to use one after the extraction.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Oral Rehabilitation, Faculty of Dentistry, The University of Hong Kong

Hong Kong, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva Toungue coatings Stool samples

MeSH Terms

Interventions

Amoxicillin

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Michael G Botelho, BDS MSc PhD

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: July 6, 2016
• First Posted: July 12, 2016
• Study Start: June 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: October 27, 2017

Record last verified: 2016-07

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)