Comparison Between Two Different Antibiotic Regimens for the Placement of Dental Implants
In order to prevent infections and complications, it has been initially established with the dental implant placement protocol that pre- and post-operative antibiotics should be prescribed to the patient receiving dental implants. There have been many antibiotic regimens used in the attempt to minimize the risks of infections and consequently, increasing the survival rate of dental implants placement procedures. However, issues about bacterial resistance have been raised recently concerning the extensive use of antibiotics. The primary objective of this study is to find out whether giving antibiotics before or after implant placement would significantly influence crestal bone loss around dental implants. One study group will receive one dosage of antibiotics before implant placement followed by post-operative intake of antibiotics for 7 days. Another group will receive the antibiotics in one single preoperative dose followed by an identical placebo for 7 days. Questionnaires for pain and interference with daily activities assessment to be filled for the first postoperative week will be distributed to participants. Signs of postoperative morbidity will be recorded at 1 and 3 weeks following the surgery, and both clinical and radiographic data will be collected at 4 months postoperative to assess the implants status. A radiographic follow-up will be done 1 year after the surgery. Peri-implant crevicular fluid levels of 3 known immunological markers for bone loss (MMP-8, sRANKL and OPG) will be measured at 1-, 3- and 16-weeks follow-ups. The findings from this study might allow clinicians to establish the ideal antibiotic regimen with minimal risk exposure to bacterial resistance.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Comparison Between Two Different Antibiotic Regimens for the Placement of Dental Implants: a Randomized Clinical Trial|
- Implants survival rate [ Time Frame: 4 months and 1 year ] [ Designated as safety issue: No ]
Clinical outcomes include: presence or absence of implant mobility, presence or absence of pain, infection, neuropathies, and pus exudate.
Radiographical outcome include the presence or absence of peri-implant radiolucency.
- Patients' pain experience [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Pain medication diary to keep track of the number of analgesics (ibuprofen 600mg) and emergency analgesics (acetaminophen 500mg) taken for the first postoperative week.
Pain intensity measured with a 10-cm VAS questionnaire where a score of 0 will mean "no pain" and 100, "intolerable pain". Also measured using the Numerical Rating Scale (NRS-11), with 0 representing "no pain" and 10 "feels like the most intense pain ever experienced".
- Patients' experience of interference with their daily activities [ Time Frame: 7 days ] [ Designated as safety issue: No ]Measured using a 10-cm daily VAS questionnaire with end points being "none" and "extremely much" (Nolan et al., 2013). Daily activities will include their ability to chew foods they want to eat, to open their mouth wide, talk, sleep, go to school or work, carry on a regular social life and participate in their favorite recreational activities.
- Surgeons' perception of healing [ Time Frame: 7 days ] [ Designated as safety issue: No ]One of the two calibrated examiners (RD, RV) unaware of the antibiotics regimen prescribed will be asked to fill a questionnaire to evaluate swelling, bruising, pus exudate and wound dehiscence as described elsewhere (Nolan et al., 2013). Postoperative swelling will be graded as follows: 0 = No swelling, 1 = Mild swelling, 2 = Moderate swelling, 3 = Severe swelling. Postoperative bruising, suppuration and wound dehiscence will be evaluated using Boolean variables: 0 = None; 1 = Present.
|Study Start Date:||July 2014|
|Estimated Study Completion Date:||September 2017|
|Estimated Primary Completion Date:||September 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Amoxicillin taken 2 g preoperatively
2 g amoxicillin 1h preop then placebo tid x 7 days
Active Comparator: Amoxicillin 2g taken preoperatively and 500mg tid x 7 days
2g amoxicillin 1h preop then tid x 7 days
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01851681
|Contact: Robert Durand, DMD, MSemail@example.com|
|Université de Montréal - Faculty of Dentistry - Dental clinics||Recruiting|
|Montreal, Quebec, Canada, H3T 1J4|
|Contact: Robert Durand, DMD, MS 514-343-7464 firstname.lastname@example.org|
|Contact: Rene Voyer, BS, DMD, MS 514-343-5926 email@example.com|
|Principal Investigator: Robert Durand, DMD, MS|
|Sub-Investigator: Rene Voyer, BS, DMD, MS|
|Sub-Investigator: Nathalie Rei, DMD, MS|
|Sub-Investigator: Pierre Boudrias, DMD, MS|
|Sub-Investigator: Simon Tran, DMD, PhD|
|Principal Investigator:||Robert Durand, DMD, MS||Université de Montréal|