Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624001151527
Ethics application status
Approved
Date submitted
23/07/2024
Date registered
23/09/2024
Date last updated
23/09/2024
Date data sharing statement initially provided
23/09/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of antibiotic prophylaxis in dental implant surgery for adult patients: Randomized controlled clinical trial.
Scientific title
Effects of antibiotic prophylaxis on rates of early implant failure in dental implant surgery for adult patients: Randomized controlled clinical trial.
Secondary ID [1] 312552 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Edentulous 334445 0
Dental Implant Failure 334446 0
Condition category
Condition code
Surgery 331068 331068 0 0
Other surgery
Oral and Gastrointestinal 331364 331364 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
Our objective is to evaluate the effect of a single dose of 2 g of oral amoxicillin administered 1h before placement of single or multiple implants placed in a single surgical field in healthy adults versus placebo. Patient adherence is controlled by direct observation.
Intervention code [1] 329066 0
Treatment: Drugs
Intervention code [2] 329067 0
Treatment: Surgery
Comparator / control treatment
Single dose of 2g of placebo (cellulose capsule) administered 1 h before placement of single or multiple implants
Control group
Placebo

Outcomes
Primary outcome [1] 338890 0
Early implant failure
Timepoint [1] 338890 0
Baseline, 7 days, 14 days, 30 days, 90 days
Secondary outcome [1] 437820 0
Presence of postoperatory infection
Timepoint [1] 437820 0
Baseline, days 1-7, 14 days, 30 days, 90 days post-surgery.
Secondary outcome [2] 437821 0
Implant stability quotient (ISQ) values for primary and secondary implant stability
Timepoint [2] 437821 0
baseline (surgery day) and 90 days post-surgery

Eligibility
Key inclusion criteria
Patients 18 years and over
• Subjects treated periodontally, if necessary, prior to placement
of implants
• Presence of sufficient bone and soft tissue that does not imply augmentation surgery in the moment of implant placement
• Implants placed in a single surgical field
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who, due to their medical condition, require antibiotic prophylaxis
postoperative (risk of endocarditis)
• Patients undergoing head and neck radiotherapy less than 2 years ago
• Diabetics (controlled and uncontrolled)
• Allergic to penicillin
• Patients treated with antiresorptive drugs
• Pregnant or breastfeeding
• Immunocompromised
• Patients who are taking antibiotics for other reasons
• Implants that require simultaneous bone regeneration
• Implants in which immediate loading is carried out
• Immediate implants

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)
sealed opaque envelopes
numbered containers
allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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
The sample size was estimated in accordance with Wittes guidelines (Wittes J. Sample size calculations for randomized controlled trials. Epidemiol Rev. 2002;24(1):39–53.) Values published by Edibam et al. (Edibam NR, Lorenzo-Pouso AI, Caponio VCA. Self-reported allergy to penicillin and clindamycin administration may be risk factors for dental implant failure: A systematic review, meta-analysis and delabeling protocol. Clin Oral Implants Res. 2023 Jul;34(7):651–61) were used to calculate the sample size for a statistical power of 90% with 95% confidence interval. A sample size of 90 patients was estimated and increased by 10% to 100 patients to cover possible losses, i.e., 50 per group.
The statistical analysis: SPSS v 29.0 (IBM SPSS, Armonk, NY) will be used for the statistical analysis. Arithmetic means with standard deviations will be calculated for quantitative variables, checking the normality of variable distribution with the Shapiro-Wilk test. Qualitative variables will be expressed as relative frequency (%) and relative risk and in contingency tables. Comparisons will be performed using the Mann-Whitney U test or Student’s t-test, as appropriate. Associations between qualitative variables will be examined with the Fisher test (for 2x2 tables) or chi-square test. a = 0.05 is considered significant.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2024
Actual
Date of last participant enrolment
Anticipated
30/04/2025
Actual
Date of last data collection
Anticipated
31/07/2025
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 26451 0
Spain
State/province [1] 26451 0
Granada

Funding & Sponsors
Funding source category [1] 316979 0
University
Name [1] 316979 0
Master in Oral Surgery and Implantology, University of Granada
Country [1] 316979 0
Spain
Primary sponsor type
University
Name
Master in Oral Surgery and Implantology, University of Granada
Address
Country
Spain
Secondary sponsor category [1] 319270 0
None
Name [1] 319270 0
Address [1] 319270 0
Country [1] 319270 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315733 0
Research Ethics Committee of the University of Granada
Ethics committee address [1] 315733 0
Ethics committee country [1] 315733 0
Spain
Date submitted for ethics approval [1] 315733 0
12/02/2024
Approval date [1] 315733 0
14/02/2024
Ethics approval number [1] 315733 0
4034/CEIH/2024

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

Contacts
Principal investigator
Name 135638 0
A/Prof Maria Victoria Olmedo Gaya
Address 135638 0
Faculty of Dentistry, University of Granada, Colegio Máximo de Cartuja s/n, Granada 18071, Spain
Country 135638 0
Spain
Phone 135638 0
+34 620900135
Fax 135638 0
Email 135638 0
[email protected]
Contact person for public queries
Name 135639 0
Fernando Bravo
Address 135639 0
Faculty of Dentistry, University of Granada, Colegio Máximo de Cartuja s/n, Granada 18071, Spain
Country 135639 0
Spain
Phone 135639 0
+34 680553131
Fax 135639 0
Email 135639 0
[email protected]
Contact person for scientific queries
Name 135640 0
Fernando Bravo
Address 135640 0
Faculty of Dentistry, University of Granada, Colegio Máximo de Cartuja s/n, Granada 18071, Spain
Country 135640 0
Spain
Phone 135640 0
+34 680553131
Fax 135640 0
Email 135640 0
[email protected]

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


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.