Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001414505
Ethics application status
Approved
Date submitted
1/10/2024
Date registered
29/11/2024
Date last updated
29/11/2024
Date data sharing statement initially provided
29/11/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Evaluating the effect of amoxicillin dosage and timing of administration on postoperative complications after retained lower third molar extraction: A double-blind randomized controlled clinical trial
Scientific title
Evaluating the effect of amoxicillin dosage and timing of administration on postoperative complications after retained lower third molar extraction: A double-blind randomized controlled clinical trial
Secondary ID [1] 313083 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
pain and inflammation in the extraction of included third molars 335588 0
Condition category
Condition code
Oral and Gastrointestinal 331896 331896 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
Arm 1: Amoxicillin 2 g 1 hour before surgery.
Arm 2: amoxicillin 500 mg administered postoperatively.
Arm 3: Amoxicillin 750 mg administered postoperatively.

Mode of administration Oral

The tab is administer by the dentist
Intervention code [1] 329640 0
Treatment: Drugs
Comparator / control treatment
Placebo glucose capsule
Control group
Placebo

Outcomes
Primary outcome [1] 339512 0
Pain
Timepoint [1] 339512 0
Daily from immediately post-procedure to 7 days post-procedure,
Primary outcome [2] 339513 0
Trismus
Timepoint [2] 339513 0
Daily from immediately post-procedure to 7 days post-procedure
Secondary outcome [1] 440259 0
Inflamation
Timepoint [1] 440259 0
Daily from immediately post-procedure to 7 days post-procedure

Eligibility
Key inclusion criteria
Retained third lower molars
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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)
sealed opaque envelopes
numbered containers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/12/2024
Actual
Date of last participant enrolment
Anticipated
13/05/2025
Actual
Date of last data collection
Anticipated
16/05/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 26593 0
Spain
State/province [1] 26593 0
Granada

Funding & Sponsors
Funding source category [1] 317527 0
University
Name [1] 317527 0
Universidad de Granada. Facultad de Odontología
Country [1] 317527 0
Spain
Primary sponsor type
University
Name
Universidad de Granada
Address
Country
Spain
Secondary sponsor category [1] 319829 0
None
Name [1] 319829 0
Address [1] 319829 0
Country [1] 319829 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316239 0
Comite etica universidad de granada
Ethics committee address [1] 316239 0
Ethics committee country [1] 316239 0
Spain
Date submitted for ethics approval [1] 316239 0
21/07/2020
Approval date [1] 316239 0
04/08/2020
Ethics approval number [1] 316239 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137250 0
Dr Pablo Valverde Martínez
Address 137250 0
Universidad de Granada - Street Horno de Haza 13, 1a. Granada, Granada 18002
Country 137250 0
Spain
Phone 137250 0
+34 622827642
Fax 137250 0
Email 137250 0
pablovmartinez@correo.ugr.es
Contact person for public queries
Name 137251 0
Pablo Valverde Martínez
Address 137251 0
Universidad de Granada - Street Horno de Haza 13, 1a. Granada, Granada. 18002
Country 137251 0
Spain
Phone 137251 0
+34 622827642
Fax 137251 0
Email 137251 0
pablovmartinez@correo.ugr.es
Contact person for scientific queries
Name 137252 0
Pablo Valverde Martínez
Address 137252 0
Universidad de Granada - Street Horno de Haza 13, 1a. Granada, Granada. 18002
Country 137252 0
Spain
Phone 137252 0
+34 622827642
Fax 137252 0
Email 137252 0
pablovmartinez@correo.ugr.es

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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.