Low Level Laser (LED) Use to Increase Dental Implant Stability and Post Operative Analgesia

Sponsor
Mount Sinai Hospital, Canada (Other)
Overall Status
Unknown status
CT.gov ID
NCT01097499
Collaborator
(none)
60
1
2
6
10

Study Details

Study Description

Brief Summary

Study hypothesis: Low level laser (LED) will reduce initial bone resorption and improve primary stability of dental implant. It will also reduces post operative pain compared to patient without treatment

Implant osseointegration depends on many factors including biocompatibility of implant materials, design, surface, surgical access, patient conditions, biomechanical status, and lack of primary stability.

Several in vivo and in vitro studies showed the healing effect of low level laser therapy (LLLT) on bone by decreasing the initial bone resorption postoperatively and increasing the primary stability of the implant. It has also shown to have an analgesic effect intraorally when used post intraoral surgical procedures. The exact mechanism is unclear despite the fact that many hypothesis has been proposed.

In our study, our goal is to present, in a randomized standardized clinical trial, the effect of LLLT on post operative implant stability assessed by resonance frequency analysis (RFA). We will assess the subjective measures of postoperative pain using visual analog scale (VAS).

Condition or Disease Intervention/Treatment Phase
  • Device: OsseoPulse device (Light emitting diode technology)
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Role of Light Emitting Diode on Implant Stability, Bone Resorption and Analgesia Post Dental Implant Placement
Study Start Date :
Apr 1, 2010
Anticipated Primary Completion Date :
Aug 1, 2010
Anticipated Study Completion Date :
Oct 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: LED application

Patients in this group will be given the LED device and will be instructed on how and when to use it. They will receive LED treatment to the surgical site preoperatively by the surgeon for 20 minutes. Then, patients in this group will apply LED at home to the surgical site postoperatively at the day of surgery and for the following 9 postoperative days.

Device: OsseoPulse device (Light emitting diode technology)
Patients in this group will be given the LED device and will be instructed on how and when to use it. They will receive LED treatment to the surgical site preoperatively by the surgeon for 20 minutes. Then, patients in this group will apply LED at home to the surgical site postoperatively at the day of surgery and for the following 9 postoperative days.
Other Names:
  • Device by Biolux Lic# 77929 (Approved by Health Canada)
  • No Intervention: No LED application

    These patients will receive conventional dental implant treatment without the application of the LED therapy.

    Outcome Measures

    Primary Outcome Measures

    1. Implant stability [Immediately post-op, 1, 2, 4, and 8 weeks]

      Implant stability and bone quality will be assessed via RFA technology using Ostelle device (Resonance Frequency Analysis technology)

    Secondary Outcome Measures

    1. Post-op analgesics [Every 3 hours the day of the surgery post-op, then every morning, and at bed time for the following 7 days]

      Analgesia will be assessed using a combination of VAS and categorical scale. Patient will fill a pre-printed form with the modified VAS every 3 hours at the day of surgery, and every morning and at night for 7 days. Pt. will also reports the time and the dose of analgesics they are taking post operatively to control pain in that form. Patients will submit all the data to the surgeons at the 1-week follow-up appointment

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
      1. English speaking
    Exclusion Criteria:
      1. Systemic factors: Diabetes, systemic immune disease, smoking (non-smoking is not absolute, but preferable.)
      1. Local factors: No immediate implants, No grafting to the site, No other implants at separate location in the mouth around the same treatment period.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mount Sinai Hospital Toronto Ontario Canada M5G 1X5

    Sponsors and Collaborators

    • Mount Sinai Hospital, Canada

    Investigators

    • Study Director: Cameron Clokie, DDS, FRCS, University of Toronto/Mount Sinai Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01097499
    Other Study ID Numbers:
    • MSH-Biolux2010
    First Posted:
    Apr 1, 2010
    Last Update Posted:
    Apr 1, 2010
    Last Verified:
    Mar 1, 2010

    Study Results

    No Results Posted as of Apr 1, 2010