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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Mount Sinai Hospital, Canada.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier:
NCT01097499
First received: March 31, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  Purpose

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 Intervention
Implant
Analgesia
Device: OsseoPulse device (Light emitting diode technology)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Role of Light Emitting Diode on Implant Stability, Bone Resorption and Analgesia Post Dental Implant Placement

Further study details as provided by Mount Sinai Hospital, Canada:

Primary Outcome Measures:
  • Implant stability [ Time Frame: Immediately post-op, 1, 2, 4, and 8 weeks ] [ Designated as safety issue: No ]
    Implant stability and bone quality will be assessed via RFA technology using Ostelle device (Resonance Frequency Analysis technology)


Secondary Outcome Measures:
  • Post-op analgesics [ Time Frame: Every 3 hours the day of the surgery post-op, then every morning, and at bed time for the following 7 days ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 60
Study Start Date: April 2010
Estimated Study Completion Date: October 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 1) English speaking

Exclusion Criteria:

  • 1) Systemic factors: Diabetes, systemic immune disease, smoking (non-smoking is not absolute, but preferable.)
  • 2) 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
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: NCT01097499

Contacts
Contact: Mahdi Ghuloom, DDS +14169958897 mahdidds@gmail.com

Locations
Canada, Ontario
Mount Sinai Hospital Not yet recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Mahdi Ghuloom, DDS    +14169958897    mahdidds@gmail.com   
Principal Investigator: Cameron Clokie, DDS, FRCS         
Sub-Investigator: Mahdi Ghuloom, DDS         
Sponsors and Collaborators
Mount Sinai Hospital, Canada
Investigators
Study Director: Cameron Clokie, DDS, FRCS University of Toronto/Mount Sinai Hospital
  More Information

No publications provided

Responsible Party: Dr. Mahdi Ghuloom, University of Toronto
ClinicalTrials.gov Identifier: NCT01097499     History of Changes
Other Study ID Numbers: MSH-Biolux2010
Study First Received: March 31, 2010
Last Updated: March 31, 2010
Health Authority: Canada: Health Canada
Canada: Ethics Review Committee

Keywords provided by Mount Sinai Hospital, Canada:
Dental implant initial stability
Initial bone resorption post implant placement
Analgesia effect of LED intervention

Additional relevant MeSH terms:
Bone Resorption
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on July 22, 2014