Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000617268
Ethics application status
Approved
Date submitted
8/07/2009
Date registered
27/07/2009
Date last updated
27/07/2009
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of systemic antibiotics on clinical and patient-centered outcomes of implant therapy- a randomised controlled clinical trial
Scientific title
The effect of systemic peri-operative antibiotic coverage on clinical and patient-centered outcomes in systemically healthy adults undergoing dental implant therapy
Universal Trial Number (UTN)
Trial acronym
Antibiotics and patient centred outcomes in implant surgery
Linked study record

Health condition
Health condition(s) or problem(s) studied:
surgical placement of dental implants 4556 0
Condition category
Condition code
Oral and Gastrointestinal 4835 4835 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
Antibiotics during implant surgery as follows:

Pre-operative antibiotics oral tablets of 2 g amoxicillin 1 hour prior to standard implant placement test group 1

Post-operative antibiotics oral tablets of 2 g amoxicillin following implant placement test group 2,

Pre-operative antibiotics oral tablets of 2 g amoxicillin 1 hour prior to standard implant placement and 500 mg thrice daily on days 2 through 3 after standard implant placement for test group 3.

The control group will be given a placebo tablet
Intervention code [1] 4310 0
Treatment: Drugs
Comparator / control treatment
placebo oral tablet (sugar pill) of 2g 1 hour prior to standard implant placement without any antibiotics.
Control group
Placebo

Outcomes
Primary outcome [1] 5706 0
patient centered outcomes
Timepoint [1] 5706 0
Visual analogue scores (VAS) on pain, swelling, bruising and bleeding will be completed by the patients on day 1,2,3,4,5,6 in the evenings before they go to bed. The Visual analogue scores for day 7 and day 14 will be completed at the chairside, as the patients will visit the clinic for suture removal and re-evaluation.
Primary outcome [2] 238352 0
Presence of surgical complications will be assessed.
Such complications might include:
suppuration,
intra oral swelling
extra oral swelling
intra / extra oral hematoma
incomplete flap closure
absess

The evaluation of such complications will be dichotomous: presence or absence
Timepoint [2] 238352 0
1 week, 2 weeks, 4 weeks and 8 weeks after surgery
Secondary outcome [1] 241621 0
clinical parametres of oral tissue healing conditions
assessed through clinical examination
(healing complications such as swelling, incomplete closure f the surgical flap, post surgical infection, suppuration etc)
Timepoint [1] 241621 0
1 week, 2 weeks, 4 weeks and 8 weeks after surgery

Eligibility
Key inclusion criteria
adult patients who require implant therapy for replacement of missing teeth, but are otherwise systemically healthy
Minimum age
20 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
pregnacy, previous antibiotic use for 6 months, allergy in Penicillin and related antibiotics, smoking.

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)
Patients candidates for receiving oral implants within the Griffith University clinic will be offered the chance to enrol in teh study if they fullfill all inclusion criteria.

allocation concealment will be done by sealed opaque envelopes prepared in the centre of Singapore, where the study administration resides.

The study will be double blind and patients will be assigned to treatment or control group through predetermined lists
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
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
1/09/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
55
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 1883 0
4215
Recruitment outside Australia
Country [1] 1715 0
Singapore
State/province [1] 1715 0
Country [2] 1716 0
Spain
State/province [2] 1716 0

Funding & Sponsors
Funding source category [1] 237294 0
Charities/Societies/Foundations
Name [1] 237294 0
International Team of Implantology (ITI)
Country [1] 237294 0
Switzerland
Primary sponsor type
Charities/Societies/Foundations
Name
International Team of Implantology (ITI)
Address
ITI Centre
Peter Merian-Weg 10
4052 Basel, Switzerland
Country
Switzerland
Secondary sponsor category [1] 236776 0
University
Name [1] 236776 0
Griffith University
Address [1] 236776 0
16-30 High Street
Southport, Gold Coast
QLD 4216
Country [1] 236776 0
Australia
Other collaborator category [1] 752 0
Government body
Name [1] 752 0
National Institute of Health, National Dental Centre
Address [1] 752 0
5 Second Hospital Avenue
Singapore 168938
Country [1] 752 0
Singapore

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239393 0
National Dental Centre Institutional Review Board
Ethics committee address [1] 239393 0
5 Second Hospital Avenue
Singapore 168938
Ethics committee country [1] 239393 0
Singapore
Date submitted for ethics approval [1] 239393 0
16/11/2008
Approval date [1] 239393 0
05/03/2009
Ethics approval number [1] 239393 0
112/2008

Summary
Brief summary
The aims of the study are to determine the effect of various systemic antibiotic prophylaxis regimes on patient-centred outcomes and perceptions, postsurgical complications in patients undergoing standard oral implant therapy. The hypothesis is that the use of both peri-operative and/or post-operative systemic antibiotics does not provide additional benefits, in terms of decreasing postsurgical complications. 336 medically healthy adults who are consecutively admitted to 7 study centres for standard oral implant therapy will be randomly assigned to one of the 4 groups (3 test and 1 control groups). Pre-operative antibiotics of 2 g amoxicillin 1 hour prior to standard implant placement will be prescribed to test group 1 (positive control), post-operative antibiotics of 2 g amoxicillin following implant placement for test group 2, and pre-operative antibiotics of 2 g amoxicillin 1 hour prior to standard implant placement and 500 mg thrice daily on days 2 through 3 after standard implant placement for test group 3. The control group will be given a placebo tablet of 2g 1 hour prior to standard implant placement without any antibiotics. Subjects will be examined clinically by blinded examiners at 1 week, 2 weeks, 4 weeks and 8 weeks from implant installation for post-operative complications. In addition, Visual analogue scores (VAS) on pain, swelling, bruising and bleeding will be obtained from the patients from day 1 through day 7 and 14. The present study will answer an important clinical question with regards to the recommendation of antibiotic usage to prevent post-operative complications (suppuration) with oral implant placement and to recommend a protocol of pre-, peri- or post-operative administration of antibiotics, if required.
Trial website
n/A
Trial related presentations / publications
Do preoperative antibiotics prevent dental implant complications?
Balevi B.
Evid Based Dent. 2008;9(4):109-10

[Dental implant-related infections]
López-Cerero L.
Enferm Infecc Microbiol Clin. 2008 Nov;26(9):589-92.

Early wound healing following one-stage dental implant placement with and without antibiotic prophylaxis: a pilot study.
Khoury SB, Thomas L, Walters JD, Sheridan JF, Leblebicioglu B. J Periodontol. 2008 Oct;79(10):1904-12.

Interventions for replacing missing teeth: antibiotics at dental implant placement to prevent complications.

Esposito M, Grusovin MG, Talati M, Coulthard P, Oliver R, Worthington HV.
Cochrane Database Syst Rev. 2008 Jul 16;(3):CD004152.
Public notes

Contacts
Principal investigator
Name 29451 0
Address 29451 0
Country 29451 0
Phone 29451 0
Fax 29451 0
Email 29451 0
Contact person for public queries
Name 12698 0
Nikos Mattheos
Address 12698 0
16-30 High Street
QLD 4215 Southport
Country 12698 0
Australia
Phone 12698 0
+61 7 5678 0725
Fax 12698 0
Email 12698 0
n.mattheos@griffith.edu.au
Contact person for scientific queries
Name 3626 0
Nikos Mattheos
Address 3626 0
16-30 High Street
QLD 4215 Southport
Country 3626 0
Australia
Phone 3626 0
+61 7 5678 0725
Fax 3626 0
Email 3626 0
n.mattheos@griffith.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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