How effective are antibiotics in preventing postoperative complications in patients after tooth extraction surgery?

ISRCTN ISRCTN26679089
DOI https://doi.org/10.1186/ISRCTN26679089
Secondary identifying numbers 0000-0001-5194-8131
Submission date
16/12/2018
Registration date
18/12/2018
Last edited
19/12/2018
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Despite evidence that antibiotics abuse is related to unknown pathogen infection, antibiotics are badly overused in China, as common people can easily buy antibiotics in pharmacy stores, even without prescriptions from doctors. The necessity and feasibility of antibiotics treatment after tooth extraction surgery, among the most common surgical operations, remain unclear. In order to ensure that the efficacy of antibiotics treatment in preventing postoperative complications in patients after tooth extraction surgery. We prescribe antibiotics for patients after tooth extraction. Then we invite then to have an examination about the wound to assess the degree of pain, swelling, opening degree and alveolitis. This study aims to recruit 200 blood donors to compare different intervals between patients with tooth extraction. The goal is to find the optimum interval for which it is safe for patients with tooth extraction.

Who can participate?
Adults over the age of 17 who have pericoronitis in the distal aspect of a third molar and are willing to have the tooth extracted at Nanjing University of Science and Technology Hospital.

What does the study involve?
Participants are asked to join this study while they are at Hospital of Nanjing University of Science and Technology in China. Participants must be over the age of 17 and have infection in the last molars. Participants are randomly allocated to one of two groups. Those in the first group as asked to took amoxicillin 0.5g/ and metronidazole 0.2g one hour postoperatively (three times every day) after tooth extraction. Those in the second group are asked to took a placebo with the same shape and dose on the same times. The study lasts for 7 days. Participants are asked to go back to check the wound in tooth extraction.

What are the possible benefits and risks of participating?
There will be no immediate direct benefit to those taking part. By taking part in this study there are no risks of physical injury or harm.

Where is the study run from?
The INTERVAL study is being run by the Nanjing University of Science and Technology and takes place in Hospital of Nanjing University of Science and Technology.

When is the study starting and how long is it expected to run for?
June 2015 to December 2017

Who is funding the study?
Wuxi Young Medical Talents (China) (No. QNRC095)

Who is the main contact?
1. Dr Lihua Yu
lihuayu178@163.com
2. Dr Xincai Zhou
75084565@qq.com
3.Dr Donglei Wu
wu1582224766@163.com

Contact information

Dr Lihua Yu
Scientific

Department of Stomatology, Hospital of Nanjing University of Science and Technology, Nanjing Jiangsu, 210049, China. Email: lihuayu178@163.com
Nanjing
210094
China

ORCiD logoORCID ID 0000-0001-5194-8131

Study information

Study designSingle-centre prospective, randomized, double-blind controlled study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typePrevention
Participant information sheet Not available in web format,please use contact details to request a partciapnt information sheet
Scientific titleEfficacy of antibiotics treatment in preventing postoperative complications in patients after tooth extraction surgery: a prospective, randomized, double-blind controlled study
Study objectivesUsing antibiotics after tooth extraction surgery does not provide additional benefits to Chinese population.
Ethics approval(s)The Institutional Review Board of Nanjing University of Science and Technology, 22/06/2015.
Health condition(s) or problem(s) studiedPericoronitis
InterventionPatients in the treatment group took amoxicillin 0.5g/ and metronidazole 0.2g one hour postoperatively (three times every day) for three days after tooth extraction. Patients in the placebo group took a placebo with the same shape and dose on the same times. Pain, swelling, mouth opening degree, and Alveolitis events were assessed at 7th days after tooth extraction.

Bilateral molars in each group was were randomly assigned to two groups using a randomization software (version 1.0; Random Allocation Software, Isfahan, Iran)
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Amoxicillin and metronidazole
Primary outcome measure1. Pain was measured using a visual analogue score (VAS) at 7th days after tooth extraction.
2. Swelling was measured as the difference between the distance (mm) between the lower earlobe and the mesomentum on the extraction side at 7th days after tooth extraction.
3. Mouth opening degree was measured as the distance between upper and lower incisors at 7th days after tooth extraction.
Secondary outcome measuresAlveolitis event was diagnosed by a dry appearance of the exposed bone in the socket after trauma.
Overall study start date01/03/2015
Completion date31/01/2018

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants200
Key inclusion criteriaCurrent inclusion criteria:
1. Have pericoronitis in the distal aspect of a third molar and pericoronitis-related lymphadenopathy.
2. Have indication for extraction of the third molars due to recurrent infections (at least two times) occurred at certain intervals.
3. Had tooth in the vertical position.
4. Had operculum covering 1/2–2/3 of the outer surface of the tooth.

Previous inclusion criteria:
1. Have pericoronitis in the distal aspect of the mandibular third molars and pericoronitis-related lymphadenopathy.
2. Have indication for extraction of the third molars due to recurrent infections (at least two times) occurred at certain intervals.
3. Had tooth in the vertical position.
4. Had operculum covering 1/2–2/3 of the outer surface of the tooth.
Key exclusion criteria1. Have a systemic disease
2. Pregnant women or women having suspicion of pregnancy
3. Lactating women
4. Received bisphosphonate at any time
5. Received antibiotic or anti-inflammatory drugs within the last month
Date of first enrolment01/07/2015
Date of final enrolment31/12/2017

Locations

Countries of recruitment

  • China

Study participating centre

Hospital of Nanjing University of Science and Technology
No.200 Xiaolingwei Street, Xuanwu District
Nanjing
210094
China

Sponsor information

Hospital of Nanjing University of Science and Technology
Hospital/treatment centre

Hospital of Nanjing University of Science and Technology, 200 xiaoling wei street, xuanwu district,Nanjing Jiangsu, 210049, China.
Nanjing
210094
China

ROR logo "ROR" https://ror.org/00xp9wg62

Funders

Funder type

Other

Wuxi Young Medical Talents (China) (No. QNRC095).

No information available

Results and Publications

Intention to publish date30/09/2019
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planPlanned publication in a high-impact peer-reviewed journal.
IPD sharing planThe data sharing plans for the current study are unknown and will be made available at a later date.

Editorial Notes

19/12/2018: The participant inclusion criteria have been changed, with the plain English summary updated to reflect this change.
18/12/2018: Internal review.