Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Dr Lihua Yu
ORCID ID
http://orcid.org/0000-0001-5194-8131
Contact details
Department of Stomatology
Hospital of Nanjing University of Science and Technology
Nanjing Jiangsu
210049
China. Email: lihuayu178@163.com
Nanjing
210094
China
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
0000-0001-5194-8131
Study information
Scientific title
Efficacy of antibiotics treatment in preventing postoperative complications in patients after tooth extraction surgery: a prospective, randomized, double-blind controlled study
Acronym
Study hypothesis
Using antibiotics after tooth extraction surgery does not provide additional benefits to Chinese population.
Ethics approval
The Institutional Review Board of Nanjing University of Science and Technology, 22/06/2015.
Study design
Single-centre prospective, randomized, double-blind controlled study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Not available in web format,please use contact details to request a partciapnt information sheet
Condition
Pericoronitis
Intervention
Patients 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 type
Drug
Phase
Not Applicable
Drug names
Amoxicillin and metronidazole
Primary outcome measure
1. 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 measures
Alveolitis event was diagnosed by a dry appearance of the exposed bone in the socket after trauma.
Overall trial start date
01/03/2015
Overall trial end date
31/01/2018
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Current 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
200
Participant exclusion criteria
1. 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
Recruitment start date
01/07/2015
Recruitment end date
31/12/2017
Locations
Countries of recruitment
China
Trial participating centre
Hospital of Nanjing University of Science and Technology
No.200 Xiaolingwei Street, Xuanwu District
Nanjing
210094
China
Sponsor information
Funders
Funder type
Other
Funder name
Wuxi Young Medical Talents (China) (No. QNRC095).
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal.
IPD sharing statement: the data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
30/09/2019
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list