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

NCT01851681 | Completed Phase 1

• 1 other identifier: 13-060-CERES-P
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implants

Keywords

dental implants; wound healing; amoxicillin; pain

Outcome Measures

Primary Outcomes (1)

• Implants survival rate

  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.

  4 months and 1 year

Secondary Outcomes (3)

• Patients' pain experience

  7 days

• Patients' experience of interference with their daily activities

  7 days

• Surgeons' perception of healing

  7 days

Study Arms (2)

Amoxicillin taken 2 g preoperatively

ACTIVE COMPARATOR

2 g amoxicillin 1h preop then placebo tid x 7 days

Drug: Amoxicillin

Amoxicillin 2g taken preoperatively and 500mg tid x 7 days

ACTIVE COMPARATOR

2g amoxicillin 1h preop then tid x 7 days

Drug: Amoxicillin

Interventions

Amoxicillin DRUG

Amoxicillin 2g taken preoperatively and 500mg tid x 7 days; Amoxicillin taken 2 g preoperatively

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Université de Montréal: lead

Study Sites (1)

Université de Montréal - Faculty of Dentistry - Dental clinics

Montreal, Quebec, H3T 1J4, Canada

Location

Related Publications (22)

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Related Links

• University of Montreal institutional website

MeSH Terms

Conditions

Pain

Interventions

Amoxicillin

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Robert Durand, DMD, MS

  Université de Montréal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: May 7, 2013
• First Posted: May 10, 2013
• Study Start: July 1, 2014
• Primary Completion: May 1, 2017
• Study Completion: May 1, 2017
• Last Updated: May 4, 2017

Record last verified: 2017-05

Locations

CA (1)