Background: In the presence of small bone defects, the bone particles produced during the preparation of the dental implant site could be used to cover the exposed implant surface. The oral cavity is not sterile and a large number of experimental studies are available on the bacterial flora inhabiting the healthy oral cavity. Bacterial contamination of the bone debris may be a cause of failure of osseointegrated oral implants. A number of studies have suggested different methods to reduce bacterial contamination of the collected bone, including antibiotic prophylaxis. Nevertheless, the role of antibiotic prophylaxis to reduce bacterial contamination of bone particles is still controversial.
Aim: To evaluate if antibiotic prophylaxis reduces the physiologically occurring bacterial contamination of bone particles collected directly from the burs used for implant site preparation
Design: Interventional, single-centre and double blinded study. Thirty patients are randomly allocated to the Test and Control groups. Antibiotic prophylaxis is given to the Test patients. The Control patients do not take antibiotic prophylaxis at all. All patients will undergo the same surgical procedure (ie, implant site preparation).
Major inclusion criteria: Good general and oral health, need to replace the absence of one tooth with an implant supported prosthesis.
Major exclusion criteria: Medical contraindications to implant therapy, active caries and chronic/aggressive periodontitis.
Intervention: One 1 gr. tablet of amoxicillin + clavulanic acid is given 12 hours and 1 hour before the surgery.
Main outcome measures: Reduction of bacterial contamination of bone particles collected directly from the burs.
General information
Acronym
*
IRCT registration information
IRCT registration number:IRCT2017102537002N1
Registration date:2017-11-14, 1396/08/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-11-14, 1396/08/23
Registrant information
Name
Giuseppe Pizzo
Name of organization / entity
University of Palermo
Country
Italy
Phone
39-091-6552221
Email address
giuseppe.pizzo@unipa.it
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2014-09-01, 1393/06/10
Expected recruitment end date
2015-02-28, 1393/12/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The role of antibiotic prophylaxis in reducing bacterial contamination of autologous bone graft collected from implant site
Public title
Evaluating a protocol of antibiotic prophylaxis to reduce bacterial contamination of the bone particles collected directly from the burs used for preparation of the dental implant site
Purpose
Prevention
Inclusion/Exclusion criteria
The study is conducted in healthy human volunteers.
Inclusion criteria: a need to replace the absence of one tooth with an implant supported prosthesis, no systemic diseases or contraindications to surgical procedures, no pregnancy, no routine drug use, no history of antibiotic therapy for 6 months prior to the study, no allergy to penicillin or related drugs, absence of carious lesions and local active inflammatory conditions or chronic/aggressive periodontits, presence of alveolar ridges of class II or III of Cawood and Howell (1988).
Exclusion criteria: systemic diseases that affect jaws and periodontium; orthodontic appliance; active dental caries; chronic diseases of the oral mucosa; chronic antibiotic usage; antiplaque mouthrinse consumption; drugs consumption which affect saliva flow rate; radiotherapy history.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Although the patients are randomly allocated to the Test and Control groups, the study does not aim to evaluate any effects on health outcomes. The physiologically occurring bacterial contamination of bone particles produced during the preparation of the implant site does not represent a “health outcome” sensu stricto. Moreover, only a minimal part of the study is conducted in a clinical setting (the collection of bone particles during the implant site preparation), while the core of the study is performed in a laboratory setting. The operator performing surgical procedures and collection of bone particles, the laboratory workers assessing the microbiological outcomes, and authors involved in organizing and managing the analysis of data will be blinded to group assignment.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Comitato Etico Palermo 1
Street address
A.O.U. Policlinico Paolo Giaccone, Via del Vespro 129
City
Palermo
Postal code
90127
Approval date
2014-07-21, 1393/04/30
Ethics committee reference number
8/2014
Health conditions studied
1
Description of health condition studied
Bacterial contamination of autologous bone particles collected from dental implant site
ICD-10 code
*
ICD-10 code description
*
Primary outcomes
1
Description
Reduction of bacterial contamination
Timepoint
Following end of treatment (antibiotic prophylaxis), during implant site preparation
Method of measurement
Counts (CFU) and identification of isolated bacteria
Secondary outcomes
empty
Intervention groups
1
Description
TEST Intervention: Antibiotic prophylaxis is prescribed to the Test group patients. One 1 gr. tablet of amoxicillin + clavulanic acid (Augmentin, GlaxoSmithKline, Verona, Italy) is given to the test group patients 12 hours and 1 hour before the surgery. All patients (Test and Control groups) will undergo the same surgical procedure (ie, implant site preparation). After local anesthesia, a full-thickness flap is made and the implant site is prepared with calibrated drills at 600 revolutions per minute, irrigated by cooled saline solution. During each step of the calibrated drills, bone particles on the coils are collected and placed in a 15 ml sterile tube containing 10 ml of prereduced thioglycolate broth. The collected samples are sent to the microbiology laboratory within one hour.
Category
Treatment - Drugs
2
Description
CONTROL Intervention: The Control group patients do not take antibiotic prophylaxis at all (No intervention). All patients (Test and Control groups) will undergo the same surgical procedure (ie, implant site preparation). It is described in the “TEST intervention” field.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Surgical, Oncological and Oral Sciences, University of Palermo
Full name of responsible person
*
Street address
Via del Vespro 129
City
Palermo
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
None
Full name of responsible person
N/A
Street address
N/A
City
N/A
Grant name
Grant code / Reference number
*
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
None
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
University of Palermo
Full name of responsible person
Giuseppe Pizzo
Position
Associate Professor
Other areas of specialty/work
Street address
Via del Vespro 129 (Plesso di Odontostomatologia)
City
Palermo
Province
PA
Postal code
90127
Phone
00390916552221
Fax
00
Email
giuseppe.pizzo@unipa.it
Web page address
*
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of Palermo
Full name of responsible person
Giuseppe Pizzo
Position
Associate Professor
Other areas of specialty/work
Street address
Via del Vespro 129 (Plesso di Odontostomatologia)
City
Palermo
Province
PA
Postal code
90127
Phone
00390916552221
Fax
00
Email
giuseppe.pizzo@unipa.it
Web page address
*
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)