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

NCT01097499 | Unknown DMC

• 1 other identifier: MSH-Biolux2010
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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).

Conditions

Implant; Analgesia

Keywords

Dental implant initial stability; Initial bone resorption post implant placement; Analgesia effect of LED intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (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

Study Arms (2)

LED application

ACTIVE COMPARATOR

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)

No LED application

NO INTERVENTION

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

Interventions

OsseoPulse device (Light emitting diode technology) DEVICE

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.

Also known as: Device by Biolux Lic# 77929 (Approved by Health Canada)

LED application

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \) English speaking

You may not qualify if:

• \) Systemic factors: Diabetes, systemic immune disease, smoking (non-smoking is not absolute, but preferable.)
• \) Local factors: No immediate implants, No grafting to the site, No other implants at separate location in the mouth around the same treatment period.

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Cameron Clokie, DDS, FRCS

  University of Toronto/Mount Sinai Hospital

  STUDY DIRECTOR

Central Study Contacts

Mahdi Ghuloom, DDS

CONTACT

+14169958897; mahdidds@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 31, 2010
• First Posted: April 1, 2010
• Study Start: April 1, 2010
• Primary Completion: August 1, 2010
• Study Completion: October 1, 2010
• Last Updated: April 1, 2010

Record last verified: 2010-03

Locations

CA (1)