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

Study Overview
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Brief Summary
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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).

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

Conditions
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Implant, Analgesia

Intervention / Treatment
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* Device: OsseoPulse device (Light emitting diode technology)


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LED application<br>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)<br>* 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.<br>* Other names: Device by Biolux Lic# 77929 (Approved by Health Canada);|
| No Intervention: No LED application<br>These patients will receive conventional dental implant treatment without the application of the LED therapy. | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental implant initial stability, Initial bone resorption post implant placement, Analgesia effect of LED intervention