Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001498381
Ethics application status
Approved
Date submitted
26/07/2017
Date registered
24/10/2017
Date last updated
16/02/2022
Date data sharing statement initially provided
16/02/2022
Date results information initially provided
16/02/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Use of antibiotic prophylaxis in the prevention of postoperative infection of third impacted mandibular molars
Scientific title
Antibiotic Prophylaxis in the prevention of infectious complications in mandibular impacted third molars extraction: A randomized clinical trial
Secondary ID [1] 292522 0
None
Universal Trial Number (UTN)
U1111-1115-1535
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Postoperative surgical wound infection in helathy people 304166 0
'Impacted third molars 304270 0
Condition category
Condition code
Oral and Gastrointestinal 303494 303494 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Infection 303617 303617 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
2 gr. Amoxicillin one hour before the surgery . Oral tablet
Intervention code [1] 298706 0
Treatment: Drugs
Intervention code [2] 298802 0
Prevention
Comparator / control treatment
Placebo: Microcellulose
Control group
Placebo

Outcomes
Primary outcome [1] 302871 0
Alveolar osteitis: “postoperative pain inside and around the extraction site, which increases in severity at any time between the first and third day after the extraction, accompanied by a partial or total disintegrated blood clot within the alveolar socket with or without halitosis. The assessment is performed by clinical examination.
Timepoint [1] 302871 0
48 hrs
7 days
30 days
Primary outcome [2] 302972 0
Surgical Site infection. The presence of surgical site infection was considered when the patient present at least one of the following characteristics:
A. Purulent drainage by surgical wound or abscess.
B. Isolation of pathogenic microorganisms in liquid or tissue culture at the surgical site.
C. Spontaneous dehiscence at the incision site in patients who exhibit at least one of the following signs of symptoms: 1) fever (> 38 ° C) 2) spontaneous pain on palpation 3 localized swelling, facial erythema or local heat.
E. Severe pain after 7th day accompanied by intraoral inflammation (moderate or severe) and/or intraoral erythema (moderate or severe) for no other justifiable reason which improves with antibiotic treatment
Timepoint [2] 302972 0
48 hrs
7 days
30 days
Primary outcome [3] 302973 0
Rescue Medication: An additional dose of analgesic used to control persistent pain that not replace or delay the next dose of analgesic indicated in the first instance.
Lysine clonexinate (tablets) 125 mg when pain is superior than 4 VAS

Rescue medication will assessed as dichotomous outcome
Timepoint [3] 302973 0
Rescue analgesia were indicated by patients reporting pain greater than 4 on the visual analog scale. 24 hours and 48 hours after surgery
Secondary outcome [1] 337272 0
Adverse reactions related to the use of amoxicillin:
Allergic reaction: Presence of urticaria and/or angiodema
Anaphylaxis: Throat or tongue swelling and / or Respiratory symptoms
Gastrointestinal Reaction: Nausea, Vomiting, Abdominal Pain, Diarrhea
The assessment is performed by clinical examinations
Timepoint [1] 337272 0
1 month

Eligibility
Key inclusion criteria
Healthy patients between 15 to 35 years old: Clinically and radiographically presence at least of one impacted mandibular third molar,
Minimum age
15 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnancy.
Allergy to penicillin and its derivatives.
Allergy to nonsteroidal anti-inflammatory drugs.
Patients with gastric ulcer.
Patients who have undergone any type of antibiotic treatment at least 30 days before surgery.
Patients with pericoronaritis episode up to 7 days before the intervention.
Patients with psychiatric illness.
Immunocompromised
Patients with addiction to narcotic drugs or illicit substances

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
allocation involved contacting the holder of the allocation schedule who was "off-site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted blocks
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical test: chi-square.

The results will be expressed as risk estimators: Absolute risk reduction. - Relative risk. Number needed to treat.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/05/2016
Date of last participant enrolment
Anticipated
6/11/2017
Actual
21/11/2017
Date of last data collection
Anticipated
8/12/2017
Actual
22/12/2017
Sample size
Target
120
Accrual to date
Final
120
Recruitment outside Australia
Country [1] 9087 0
Chile
State/province [1] 9087 0
Santiago

Funding & Sponsors
Funding source category [1] 297105 0
University
Name [1] 297105 0
Facultad de Odontología Universidad de Chile
Country [1] 297105 0
Chile
Primary sponsor type
University
Name
Facultad de Odontología. Universidad de Chile
Address
Sergio Livingstone P 943. Independencia, postcode 8380492 Santiago
Country
Chile
Secondary sponsor category [1] 296114 0
Hospital
Name [1] 296114 0
Hospital Clínico San Borja Arriaran
Address [1] 296114 0
Santa Rosa 1234, Santiago Centro
postcode 8360160
Country [1] 296114 0
Chile
Secondary sponsor category [2] 296115 0
University
Name [2] 296115 0
Facultad de Odontología. Universidad Complutense de Madrid
Address [2] 296115 0
Pza. Ramón y Cajal, s/n, 28040 Madrid
Country [2] 296115 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298282 0
Comite etico cientifico del Servicio de Salud Metropolitano Central
Ethics committee address [1] 298282 0
Victoria Subercaseaux 381. Postcode 8320143.
Santiago
Ethics committee country [1] 298282 0
Chile
Date submitted for ethics approval [1] 298282 0
14/03/2016
Approval date [1] 298282 0
26/04/2016
Ethics approval number [1] 298282 0
27/16

Summary
Brief summary
Third molar surgery is the most frequent procedure in oral and maxillofacial surgery. Surgical wound infection is the most prevalent complication.
Determine if the use of 2 gr. of Amoxicillin as AP reduces the proportion of postoperative infectious complications in the impacted third molar extraction compared to placebo.
To determine the proportion of postoperative infectious complications of the experimental group (2 gr Amoxicillin) and control group (placebo) derived from the exodoncia of impacted mandibular third molars.
To compare the proportion of postoperative infectious complications of the experimental group versus the control group.
To compare the proportion of rescue medication requirement associated with postoperative pain between the experimental group versus the control group.
Describe any adverse reactions resulting from the use of 2 gr. Amoxicillin as AP.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31222 0
Dr Nicolas Yanine Montaner
Address 31222 0
Facultad de Odontologia. Universidad de Chile
Sergio Livingstone P 943, Independencia 8380492
Santiago
Country 31222 0
Chile
Phone 31222 0
+56990653100
Fax 31222 0
Email 31222 0
nyanine@u.uchile.cl
Contact person for public queries
Name 14469 0
Prof Julio Villanueva Maffei
Address 14469 0
Facultad de Odontología Universidad de Chile
Sergio Livingstone P 943, Independencia 8380492
Santiago
Country 14469 0
Chile
Phone 14469 0
+56998273373
Fax 14469 0
Email 14469 0
javm@uchile.cl
Contact person for scientific queries
Name 5397 0
Dr Nicolas Yanine Montaner
Address 5397 0
Facultad de Odontología Universidad de Chile
Sergio Livingstone P 943, Independencia 8380492
Santiago
Country 5397 0
Chile
Phone 5397 0
+56990653100
Fax 5397 0
Email 5397 0
nyanine@u.uchile.cl

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.