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

Role of Light Emitting Diode on Implant Stability, Bone Resorption and Analgesia Post Dental Implant Placement

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).

Study Overview

• Status: Unknown
• Conditions: Analgesia; Implant
• Intervention / Treatment: Device: OsseoPulse device (Light emitting diode technology)

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X5
      • Mount Sinai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Implant stability	Implant stability and bone quality will be assessed via RFA technology using Ostelle device (Resonance Frequency Analysis technology)	Immediately post-op, 1, 2, 4, and 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-op analgesics	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	Every 3 hours the day of the surgery post-op, then every morning, and at bed time for the following 7 days

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Anticipated): August 1, 2010
• Study Completion (Anticipated): October 1, 2010

Study Registration Dates

• First Submitted: March 31, 2010
• First Submitted That Met QC Criteria: March 31, 2010
• First Posted (Estimate): April 1, 2010

Study Record Updates

• Last Update Posted (Estimate): April 1, 2010
• Last Update Submitted That Met QC Criteria: March 31, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: Dental implant initial stability; Initial bone resorption post implant placement; Analgesia effect of LED intervention
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Musculoskeletal Diseases; Bone Diseases; Perceptual Disorders; Bone Resorption; Agnosia
• Other Study ID Numbers: MSH-Biolux2010