Impact of Antibiotic Treatment and Extraction on the Oral Micro Biome

NCT02951676 | Unknown DMC

• 1 other identifier: UW 15-482
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Impacted Third Molar Tooth

Outcome Measures

Primary Outcomes (1)

• Microbiome shift

  Baseline - Six months

Secondary Outcomes (2)

• Antibiotic resistance genes count

  Baseline - One Month

• levels of c reactive protein

  Baseline - One Month

Study Arms (3)

EA - Extraction with antibiotics

Patients undergoing third molar extraction with antibiotic treatment. Amoxicillin 250 mg , three times daily for five days.

Procedure: Extraction

E - Extraction without antibiotics

Patients undergoing third molar extraction with antibiotic treatment.

Procedure: Extraction

Control

Age and sex matched controls who are not undergoing extractions or antibiotic treatment

Interventions

Extraction PROCEDURE

Extraction of impacted third molar teeth

E - Extraction without antibiotics; EA - Extraction with antibiotics

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 on the waiting list of third molar extractions at the Prince Philip Dental Hospital, Hong Kong

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. 5. No medical condition that prevents the surgical procedure or antibiotic therapy.
• \. 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.

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, Guangdong, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Saliva Supragingival plaque

Study Officials

• Michael G Botelho, BDS,MsC,PhD

  Faculty of Dentistry, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: October 30, 2016
• First Posted: November 1, 2016
• Study Start: December 1, 2015
• Primary Completion: March 1, 2018
• Study Completion: June 1, 2018
• Last Updated: October 26, 2017

Record last verified: 2017-01

Locations

CN (1)