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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
Information provided by (Responsible Party):
Robert Durand, Université de Montréal

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dental Implants Drug: Amoxicillin Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Comparison Between Two Different Antibiotic Regimens for the Placement of Dental Implants: a Randomized Clinical Trial
Study Start Date : July 2014
Primary Completion Date : May 1, 2017
Study Completion Date : May 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Amoxicillin taken 2 g preoperatively
2 g amoxicillin 1h preop then placebo tid x 7 days
Drug: Amoxicillin
Active Comparator: Amoxicillin 2g taken preoperatively and 500mg tid x 7 days
2g amoxicillin 1h preop then tid x 7 days
Drug: Amoxicillin

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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".

  2. 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.

  3. 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.

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subjects more than 34 years old and less than 76 years old.
  • Periodontally healthy remaining dentition or presenting with mild gingivitis with adequate oral hygiene.
  • Presence of a partially edentulous alveolar ridge that is planned to be restored with no more than 2 implants.
  • Presence of a non-infected site.
  • Presence of enough bone and soft tissue for the implant to be placed without additional bone augmentation in a 1-stage approach (with healing abutment).
  • Implants 8mm long or longer.
  • Subjects able and willing to provide written informed consent and comply with study procedures.

Exclusion Criteria:

  • Subjects taking regular analgesics or antidepressants.
  • Smoking 10 cigarettes/cigars or more per day.
  • Drug abuse.
  • Completely edentulous individuals.
  • Pregnant and nursing women.
  • Allergies to amoxicillin and/or non-steroidal anti-inflammatory analgesics.
  • Any systemic or local immunodeficiency.
  • Any blood coagulation impairment.
  • Presence of uncontrolled periodontitis or poor oral hygiene.
  • Presence of any acute oral infection.
  • Presence of uncontrolled diabetes or other systemic diseases.
  • Previous radiation therapy in the head and neck area.
  • Intravenous bisphosphonates.
  • Oral bisphosphonates intake for more than 3 years.
  • Long-term intake of corticosteroids.
  • Need for routine prophylactic antibiotics prior dental surgery.

Information from the National Library of Medicine

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

Canada, Quebec
Université de Montréal - Faculty of Dentistry - Dental clinics
Montreal, Quebec, Canada, H3T 1J4
Sponsors and Collaborators
Université de Montréal
Principal Investigator: Robert Durand, DMD, MS Université de Montréal

Additional Information:

Responsible Party: Robert Durand, Associate professor, Université de Montréal
ClinicalTrials.gov Identifier: NCT01851681     History of Changes
Other Study ID Numbers: 13-060-CERES-P
First Posted: May 10, 2013    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017

Keywords provided by Robert Durand, Université de Montréal:
dental implants
wound healing

Additional relevant MeSH terms:
Anti-Bacterial Agents
Anti-Infective Agents