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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ANZCTR
Last refreshed on: 21 February 2022
Main ID:  ACTRN12617001498381
Date of registration: 24/10/2017
Prospective Registration: No
Primary sponsor: Facultad de Odontología. Universidad de Chile
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
Date of first enrolment: 02/05/2016
Target sample size: 120
Recruitment status: Completed
URL:  https://anzctr.org.au/ACTRN12617001498381.aspx
Study type:  Interventional
Study design:  Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy;  
Phase:  Phase 4
Countries of recruitment
Chile
Contacts
Name: Prof Julio Villanueva Maffei   
Address:  Facultad de Odontología Universidad de Chile Sergio Livingstone P 943, Independencia 8380492 Santiago Chile
Telephone: +56998273373
Email: javm@uchile.cl
Affiliation: 
Name: Dr Nicolas Yanine Montaner   
Address:  Facultad de Odontología Universidad de Chile Sergio Livingstone P 943, Independencia 8380492 Santiago Chile
Telephone: +56990653100
Email: nyanine@u.uchile.cl
Affiliation: 
Key inclusion & exclusion criteria
Inclusion criteria: Healthy patients between 15 to 35 years old: Clinically and radiographically presence at least of one impacted mandibular third molar,

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


Age minimum: 15 Years
Age maximum: 35 Years
Gender: Both males and females
Health Condition(s) or Problem(s) studied
Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Infection - Other infectious diseases
Postoperative surgical wound infection in helathy people;'Impacted third molars;
Postoperative surgical wound infection in helathy people
'Impacted third molars
Intervention(s)
2 gr. Amoxicillin one hour before the surgery . Oral tablet
Primary Outcome(s)
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.[48 hrs
7 days
30 days
]
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[Rescue analgesia were indicated by patients reporting pain greater than 4 on the visual analog scale. 24 hours and 48 hours after surgery
]
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

[48 hrs
7 days
30 days
]
Secondary Outcome(s)
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
[1 month]
Secondary ID(s)
None
Source(s) of Monetary Support
Facultad de Odontología Universidad de Chile
Secondary Sponsor(s)
Hospital Clínico San Borja Arriaran
Facultad de Odontología. Universidad Complutense de Madrid
Ethics review
Status: Approved
Approval date: 26/04/2016
Contact:
Comite etico cientifico del Servicio de Salud Metropolitano Central
Results
Results available: Yes
Date Posted: 16/02/2022
Date Completed: 22/12/2017
URL:
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