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

Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01097499
• Other study ID #: MSH-Biolux2010
• Status: Not yet recruiting
• Phase: N/A
• First received: March 31, 2010
• Last updated: March 31, 2010
• Start date: April 2010
• Est. completion date: October 2010

Study information

• Verified date: March 2010
• Source: Mount Sinai Hospital, Canada
• Contact: Mahdi Ghuloom, DDS
• Phone: +14169958897
• Email: mahdidds[@]gmail.com
• Is FDA regulated: No
• Health authority: Canada: Health CanadaCanada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: October 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Analgesia
• Bone Resorption
• Implant

Intervention

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.

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Mount Sinai Hospital, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No