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Comparison Between Two Different Antibiotic Regimens for the Placement of Dental Implants

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Université de Montréal
Sponsor:
Information provided by (Responsible Party):
Robert Durand, Université de Montréal
ClinicalTrials.gov Identifier:
NCT01851681
First received: May 7, 2013
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Dental Implants
Drug: Amoxicillin
Phase 1

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Université de Montréal:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 50
Study Start Date: July 2014
Estimated Primary Completion Date: September 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01851681

Contacts
Contact: Robert Durand, DMD, MS 514-343-7464 robert.durand@umontreal.ca

Locations
Canada, Quebec
Université de Montréal - Faculty of Dentistry - Dental clinics Recruiting
Montreal, Quebec, Canada, H3T 1J4
Contact: Robert Durand, DMD, MS    514-343-7464    robert.durand@umontreal.ca   
Contact: Rene Voyer, BS, DMD, MS    514-343-5926    rene.voyer@umontreal.ca   
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         
Sponsors and Collaborators
Université de Montréal
Investigators
Principal Investigator: Robert Durand, DMD, MS Université de Montréal
  More Information

Additional Information:
Publications:

Responsible Party: Robert Durand, Assistant professor, Université de Montréal
ClinicalTrials.gov Identifier: NCT01851681     History of Changes
Other Study ID Numbers: 13-060-CERES-P
Study First Received: May 7, 2013
Last Updated: July 3, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Université de Montréal:
dental implants
wound healing
amoxicillin
pain

Additional relevant MeSH terms:
Amoxicillin
Anti-Bacterial Agents
Anti-Infective Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014