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

NCT ID: NCT01097499

Last Updated: 2010-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2010-10-31

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).

Detailed Description

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Conditions

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Implant Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

OsseoPulse device (Light emitting diode technology)

Intervention Type 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.

No LED application

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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Device by Biolux Lic# 77929 (Approved by Health Canada)

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mount Sinai Hospital, Canada

OTHER

Sponsor Role lead

Responsible Party

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University of Toronto

Principal Investigators

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Cameron Clokie, DDS, FRCS

Role: STUDY_DIRECTOR

University of Toronto/Mount Sinai Hospital

Locations

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Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Central Contacts

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Mahdi Ghuloom, DDS

Role: CONTACT

+14169958897

Facility Contacts

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Mahdi Ghuloom, DDS

Role: primary

+14169958897

Other Identifiers

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MSH-Biolux2010

Identifier Type: -

Identifier Source: org_study_id

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