Impacted Third Molar Tooth Clinical Trial
Official title:
The Impact of Amoxicillin Use on the Stability of the Oral Microbiome in Systemically Healthy Cohorts Undergoing Tooth Extractions - A Prospective Clinical Study
Verified date | January 2017 |
Source | The University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This is a prospective, longitudinal, observational, cohort study investigating young adults
undergoing surgical extraction of a wisdom tooth with and without antibiotics
post-operatively. The prescription of antibiotics will be based on clinical judgment based on
case complexity, trauma and length of procedure. No randomization will be performed. Saliva
will be collected at seven observational time points ( Baseline, one week ,two weeks, three
weeks , one month,three months and six months.) and Supragingival plaque samples will be
collected at four observational time points ( Baseline , one week , one month, and 3 months)
.A control group of 15 subjects who do not undergo dental extractions or antibiotic treatment
will be recruited after obtaining informed consent and will be followed up for the same seven
time points..Routine standard care will be observed. No new medications are triedThe samples
will be analysed for identification of bacterial genes using 16 S r RNA gene sequecing and
QPCR for change in the antibiotic resistance genes overtime. Kindly note that in the current
study the participants are patients who are already scheduled to undergo tooth extractions
with or without antibiotic treatment based on clinical judgement by the clinician performing
the extraction. ( These patients are on the waiting list for third molar extractions in the
dental hospital concerned.)
The participants will receive the intervention( Third molar extraction with /without
antibiotics) in the same manner and intensity even if they are not enrolled for the study.
Status | Active, not recruiting |
Enrollment | 67 |
Est. completion date | June 2018 |
Est. primary completion date | March 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 45 Years |
Eligibility |
Inclusion Criteria: 1. Men and women aged between 18 and 45 years 2. Subjects who are scheduled to have a surgical tooth extraction. 3. Subjects who have signed an informed consent after being informed of the study design, objectives and, risks/benefits 4. No history of use of antibiotics up to three months prior to participation in the study. 5. No medical condition that prevents the surgical procedure or antibiotic therapy. 6. No history of hypersensitivity to beta lactams. 7. No contraindication to amoxicillin therapy. 8. Subjects are not pregnant or currently breast feeding. 9. No known or suspected immunodeficiency. 9 EXCLUSION CRITERIA 1. History of antibiotic use within 3 months from baseline evaluation. 2. Any medical condition that prevents the surgical procedure or antibiotic therapy. 3. History of hypersensitivity to beta lactams 4. Contraindication for amoxicillin therapy 5. Pregnant or breast feeding women. 6. Subjects with known or suspected immunodeficiency. 7. Caries active subjects defined as subjects with active caries involving more than 3 teeth. 8. Subjects diagnosed with chronic periodontitis. 9. Subjects regularly using an antibacterial mouth rinse or planning to use one after the extraction. |
Country | Name | City | State |
---|---|---|---|
China | Oral Rehabilitation, Faculty of Dentistry, The University of Hong Kong | Hong Kong | Guangdong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Microbiome shift | Baseline - Six months | ||
Secondary | Antibiotic resistance genes count | Baseline - One Month | ||
Secondary | levels of c reactive protein | Baseline - One Month |
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