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

Not Applicable

• Conditions: Implant; Analgesia
• Interventions: Device: OsseoPulse device (Light emitting diode technology)

• Registration Number: NCT01097499
• Lead Sponsor: Mount Sinai Hospital, Canada

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2010-03
• Study First Submitted: 2010-03-31
• Study First Submitted QC: 2010-03-31
• Last Update Submitted: 2010-03-31
• Study Start: 2010-04
• Study First Posted: 2010-04-01
• Last Update Posted: 2010-04-01
• Primary Completion: 2010-08
• Study Completion: 2010-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LED application	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada