Comparison Between Two Different Antibiotic Regimens for the Placement of Dental Implants
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|ClinicalTrials.gov Identifier: NCT01851681|
Recruitment Status : Completed
First Posted : May 10, 2013
Last Update Posted : May 4, 2017
|Condition or disease||Intervention/treatment||Phase|
|Dental Implants||Drug: Amoxicillin||Phase 1|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Comparison Between Two Different Antibiotic Regimens for the Placement of Dental Implants: a Randomized Clinical Trial|
|Study Start Date :||July 2014|
|Actual Primary Completion Date :||May 1, 2017|
|Actual Study Completion Date :||May 1, 2017|
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
- Implants survival rate [ Time Frame: 4 months and 1 year ]
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 ]
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 ]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 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01851681
|Université de Montréal - Faculty of Dentistry - Dental clinics|
|Montreal, Quebec, Canada, H3T 1J4|
|Principal Investigator:||Robert Durand, DMD, MS||Université de Montréal|