Condition category
Oral Health
Date applied
16/12/2018
Date assigned
18/12/2018
Last edited
19/12/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

Organisation

Hospital of Nanjing University of Science and Technology

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

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.