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Trial registered on ANZCTR


Registration number
ACTRN12624000324516
Ethics application status
Approved
Date submitted
14/09/2023
Date registered
25/03/2024
Date last updated
25/03/2024
Date data sharing statement initially provided
25/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Influence of Clindamicyn and Amoxicillin in early dental implant failure
Scientific title
Influence of preoperative clindamicyn and amoxicillin in reducing early dental implant failure. A randomised controlled clinical trial.
Secondary ID [1] 310598 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
early dental implant failure 331475 0
Condition category
Condition code
Oral and Gastrointestinal 328203 328203 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Surgery 330015 330015 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Prophylactic use of Clindamycin 600mg or Amoxicillin 2g 1hour prior dental implant surgery.
In both cases the mode of administration by oral tablets.
In order to monitor the patient adherence, they will return the drug tablet after the administration.
Intervention code [1] 327008 0
Prevention
Intervention code [2] 328255 0
Treatment: Drugs
Comparator / control treatment
The control treatment is the prophylactic use of 2g of Amoxicillin 1hour prior the implant surgery.
The mode of administration by oral tablets.
In order to monitor the patient adherence they will return the drug tablet after the administration.
Control group
Active

Outcomes
Primary outcome [1] 336079 0
Early dental implant failure.
The diagnosis will be assessed using intraoral x-rays by the presence of peri-implant radiolucency or manual mobility.
Timepoint [1] 336079 0
3 months after dental implant surgery
Secondary outcome [1] 426773 0
osseointegration using Implant stability quotient (ISQ scale) by resonance frequency analysis
Timepoint [1] 426773 0
3 months after dental implant surgery
Secondary outcome [2] 426774 0
Pain using VAS scale
Timepoint [2] 426774 0
7 days after dental implant surgery
Secondary outcome [3] 426775 0
Swelling using VAS scale
Timepoint [3] 426775 0
7 days after dental implant surgery

Eligibility
Key inclusion criteria
Susceptible healthy patients for dental implants in molars and premolars at least 18 years old.
Periodontal controlled patients
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inmunocompromised patients
Diabetes patients
Areas in which a bone or soft tissue regeneration is needed
Post extraction dental implants
Inmediate loading dental implants
allergy to any drugs used in the trial
Decompensated systemic pathologies (cardiac, respiratory,
endocrine, metabolic, hepatic, haematological, the risk of
bacterial endocarditis, or immunosuppression)oking patients
Smokers
history or use of bisphosphonates, anticoagulants, or antiplatelet agents
Patients with amannesis reports that they have had been irradiated in the cervical and
maxillofacial territory, were pregnant, suspected of being pregnant or
breastfeeding, or with a history of antibiotic-associated ulcerous colitis.

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)
numbered containers
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
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
18/06/2024
Actual
Date of last participant enrolment
Anticipated
25/06/2024
Actual
Date of last data collection
Anticipated
24/09/2024
Actual
Sample size
Target
82
Accrual to date
Final
Recruitment outside Australia
Country [1] 25769 0
Spain
State/province [1] 25769 0
Granada

Funding & Sponsors
Funding source category [1] 314812 0
University
Name [1] 314812 0
University of Granada
Country [1] 314812 0
Spain
Primary sponsor type
Individual
Name
Diego Pradillo Gallego
Address
University of Granada/Colegio Máximo s/n, Campus Universitario de Cartuja/ 18071/ Granada/Spain
Country
Spain
Secondary sponsor category [1] 316801 0
Other Collaborative groups
Name [1] 316801 0
BIO 277
Address [1] 316801 0
University of Granada/Colegio Máximo s/n, Campus Universitario de Cartuja/ 18071/ Granada/Spain
Country [1] 316801 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313817 0
Comité de Ética en Investigación Humana (CEIH) de la Universidad de Granada
Ethics committee address [1] 313817 0
Avda. del Hospicio, s/n C.P. 18010 Granada
Ethics committee country [1] 313817 0
Spain
Date submitted for ethics approval [1] 313817 0
16/12/2019
Approval date [1] 313817 0
13/01/2020
Ethics approval number [1] 313817 0

Summary
Brief summary
The purpose of the study is to compare the use of preoperative Clindamycin 600mg in non allergic penicillin patients in comparison with 2g Amoxicillin 1h before dental implant surgery in relation with early dental implant failure. In penicillin allergic patients there is an increase of early dental implant failure when clindamycin is used in comparison with non allergic when amoxicillin is used. There is only one clinical trial comparing Clindamycin versus placebo. All the previous studies use a postoperative antibiotic regimen with clindamycin that may affect increasing early dental implant failure.
Trial website
Trial related presentations / publications
Please note that it is no longer possible to add trial related presentations/publications in this field.
Public notes

Contacts
Principal investigator
Name 129438 0
Mr DIEGO PRADILLO GALLEGO
Address 129438 0
University of Granada/ Colegio Máximo s/n /Campus Universitario de Cartuja/ 18071/ Granada/Spain
Country 129438 0
Spain
Phone 129438 0
+34 630833526
Fax 129438 0
Email 129438 0
[email protected]
Contact person for public queries
Name 129439 0
DIEGO PRADILLO GALLEGO
Address 129439 0
University of Granada/ Colegio Máximo s/n /Campus Universitario de Cartuja/ 18071/ Granada/Spain
Country 129439 0
Spain
Phone 129439 0
+34 630833526
Fax 129439 0
Email 129439 0
[email protected]
Contact person for scientific queries
Name 129440 0
DIEGO PRADILLO GALLEGO
Address 129440 0
University of Granada/ Colegio Máximo s/n /Campus Universitario de Cartuja/ 18071/ Granada/Spain
Country 129440 0
Spain
Phone 129440 0
+34 630833526
Fax 129440 0
Email 129440 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?
individual participant data underlying published results only
When will data be available (start and end dates)?
immediately following publication, no end date
Available to whom?
only researchers who provide a methodologically sound proposal
Available for what types of analyses?
any purpose
How or where can data be obtained?
access subject to approvals by Principal Investigator ([email protected])


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.