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Trial registered on ANZCTR


Registration number
ACTRN12619000149167
Ethics application status
Approved
Date submitted
13/12/2018
Date registered
1/02/2019
Date last updated
1/02/2019
Date data sharing statement initially provided
1/02/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Antibiotic efficacy when extracting lower third molars
Scientific title
Preoperative and postoperative antibiotic prophylaxis efficacy against placebo when extracting impacted mandibular third molars
Secondary ID [1] 296781 0
Nil known
Universal Trial Number (UTN)
U1111-1224-8832
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Third molar extraction 310795 0
Condition category
Condition code
Oral and Gastrointestinal 309465 309465 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of preoperative and postoperative antibiotic prophylaxis for the extraction of retained mandibular third molar. Patients will be divided in three groups.
-Group 1: it will be formed by thirty patients. They will be given one tablet of amoxicillin 750 mg each 8 hours. Patients will start the treatment two days before the extraction and will continue it until five days later.
-Group 2: it will be formed by thirty patients. This group will take a placebo two days before the extraction and will take the same amoxicillin 750 mg treatment each 8 hours 5 days later.
-Group 3: it will be formed by thirty patients too. They will be administrated placebo each 8 hours. Patients will start the treatment two days before the extraction and will continue it until five days later.
The extractions will be made by students of the Master of Oral Surgery and Implantology in the University of Granada.
For monitoring the intervention, the principal investigator will require drug tablet return 7 days after the extraction.
The antibiotic and placebo tablets will have the same size and color. In this way, all patients (Group 1, 2 or 3) will start taking medication (placebo or antibiotic according to the group) two days before the tooth extraction and continue 5 days after
Intervention code [1] 313149 0
Treatment: Drugs
Comparator / control treatment
Methylcellulose tablet
Control group
Placebo

Outcomes
Primary outcome [1] 308430 0
Presence of infection in patients who have taken antibiotic and those who have not, for the extraction of a third molar.
The presence of infection will be assessed according to diagnostic criteria, which are pus in the extraction area, fever higher than 38 ºC after 48 hours or persistent inflammation 7 days later.
Timepoint [1] 308430 0
At 7 days after intervention
Secondary outcome [1] 354938 0
Difference of pain in the extraction area between groups, assessed using a Visual Analogue Scale (VAS)
Timepoint [1] 354938 0
At baseline, at 1 hour, at 2 hours, at 24 hours, at 2 days, at 3 days and at 7 days after intervention
Secondary outcome [2] 354939 0
Difference of inflammation in the extraction area between groups, assessed using a Visual Analogue Scale (VAS) and a Gabka and Matsumara Scale
Timepoint [2] 354939 0
At baseline, at 1 hour, at 2 hours, at 24 hours, ar 2 days, at 3 days and at 7 days after intervention
Secondary outcome [3] 354940 0
Use of rescue analgesics between groups.
The rescue analgesic will be paracetamol 1 gr, 1 tablet every 8 hours.
The patient will be prescribed Ibuprofen 600 mg, 1 tablet every 8 hours as a routine analgesic after extraction. If the patient needs to take rescue analgesic after extraction, we will mark YES on the data collection sheet.
Timepoint [3] 354940 0
At 7 days after intervention

Eligibility
Key inclusion criteria
Volunteer patients of the Master of Oral Surgery and Implantology demanding an extraction of a third lower molar
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnant or breastfeeding period.
-Patients with some systemic pathology. Only patients ASA I (classification of the American Society of Anesthesiology) will be included in the study.
- Previous medical allergies to any drugs used in this study
- Patients have taken antibiotics one week before the surgery

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered containers with the treatment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table from a statistic book
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample was determined with a confidence level of 95% and a power of 90%. We calculated a total sample of 90 patients (30 in each treatment group)
Statistical analysis will be carried out using the SPSS v 21.0 program (SPSS Inc., Chicago, IL). Analysis of qualitative variables will be carried out through frequency tables, contingency tables, along with bar graphs. Analysis of quantitative variables will be carried out through a statistical summary that includes coefficients of centralization and dispersion (arithmetic mean, median, standard deviation, minimum and maximum). The normality of variables will be verified by the Shapiro-Wilk test. The comparison between treatments for quantitative variables will be carried out using the Kruskall-Wallis or ANOVA test, and multiple comparisons between treatments using the Games-Howell test. In all the tests performed, the level of significance, a, will be set at a = 0.05.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
7/05/2018
Date of last participant enrolment
Anticipated
22/03/2019
Actual
Date of last data collection
Anticipated
5/04/2019
Actual
Sample size
Target
90
Accrual to date
21
Final
Recruitment outside Australia
Country [1] 21125 0
Spain
State/province [1] 21125 0
Granada

Funding & Sponsors
Funding source category [1] 301357 0
University
Name [1] 301357 0
Master of Oral Surgery and Implantology. Faculty of Dentistry, University of Granada
Country [1] 301357 0
Spain
Primary sponsor type
Individual
Name
María del Mar Mariscal Cazalla
Address
Colegio Máximo s/n. Campus Universitario de Cartuja. 18071. Granada, Spain
Country
Spain
Secondary sponsor category [1] 301027 0
None
Name [1] 301027 0
Address [1] 301027 0
Country [1] 301027 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302099 0
Comité de ética en investigación de la Universidad de Granada
Ethics committee address [1] 302099 0
VICERECTORADO DE INVESTIGACION Y TRANSFERENCIA. Calle Gran Vía de Colon. Nº 48, 2 planta. 18071, Granada
Ethics committee country [1] 302099 0
Spain
Date submitted for ethics approval [1] 302099 0
Approval date [1] 302099 0
02/05/2018
Ethics approval number [1] 302099 0
533/CEIH/2018

Summary
Brief summary
Due to the current increase of bacterial resistance to antibiotics, our main objective is to assess whether the use of an antibiotic for the extraction of a retained mandibular third molar is really useful in reducing the risk of infection.
In this study we will compare the infection, inflammation and pain in patients who have taken different antibiotic treatments and patients who have not taken any antibiotics.
Our study hypothesis is that in healthy patients won't be necessary any antibiotic treatment for the extraction of a third molar without infection, so that we can reduce the consumption of antibiotics and the presence of bacterial resistances.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 89106 0
Miss Maria del Mar Mariscal Cazalla
Address 89106 0
Faculty of dentistry. Colegio Máximo, Campus Universitario de Cartuja C.P. 18071 (Granada). Spain
Country 89106 0
Spain
Phone 89106 0
+34 678924560 (for Granada, Spain)
Fax 89106 0
Email 89106 0
[email protected]
Contact person for public queries
Name 89107 0
Maria del Mar Mariscal Cazalla
Address 89107 0
Faculty of dentistry. Colegio Máximo, Campus Universitario de Cartuja C.P. 18071 (Granada). Spain
Country 89107 0
Spain
Phone 89107 0
+34 678924560 (for Granada, Spain)
Fax 89107 0
Email 89107 0
[email protected]
Contact person for scientific queries
Name 89108 0
Maria del Mar Mariscal Cazalla
Address 89108 0
Faculty of dentistry. Colegio Máximo, Campus Universitario de Cartuja C.P. 18071 (Granada). Spain
Country 89108 0
Spain
Phone 89108 0
+34 678924560 (for Granada, Spain)
Fax 89108 0
Email 89108 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All of the individual participant data collected during the trial
When will data be available (start and end dates)?
Immediately following publication, no end date
Available to whom?
Only researchers that contact with principal investigator and who provide a methodologically sound proposal
Available for what types of analyses?
For IPD meta-analyses and systematic revisions
How or where can data be obtained?
Access subject to approvals by Principal Investigator when researchers contact with principal investigator by email


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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