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

Primary Purpose

Implant, Analgesia

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
OsseoPulse device (Light emitting diode technology)
Sponsored by
Mount Sinai Hospital, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Implant focused on measuring Dental implant initial stability, Initial bone resorption post implant placement, Analgesia effect of LED intervention

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Mount Sinai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

LED application

No LED application

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Implant stability
Implant stability and bone quality will be assessed via RFA technology using Ostelle device (Resonance Frequency Analysis technology)

Secondary Outcome Measures

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

Full Information

First Posted
March 31, 2010
Last Updated
March 31, 2010
Sponsor
Mount Sinai Hospital, Canada
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1. Study Identification

Unique Protocol Identification Number
NCT01097499
Brief Title
Low Level Laser (LED) Use to Increase Dental Implant Stability and Post Operative Analgesia
Official Title
Role of Light Emitting Diode on Implant Stability, Bone Resorption and Analgesia Post Dental Implant Placement
Study Type
Interventional

2. Study Status

Record Verification Date
March 2010
Overall Recruitment Status
Unknown status
Study Start Date
April 2010 (undefined)
Primary Completion Date
August 2010 (Anticipated)
Study Completion Date
October 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Mount Sinai Hospital, Canada

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Implant, Analgesia
Keywords
Dental implant initial stability, Initial bone resorption post implant placement, Analgesia effect of LED intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LED application
Arm Type
Active Comparator
Arm Description
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.
Arm Title
No LED application
Arm Type
No Intervention
Arm Description
These patients will receive conventional dental implant treatment without the application of the LED therapy.
Intervention Type
Device
Intervention Name(s)
OsseoPulse device (Light emitting diode technology)
Other Intervention Name(s)
Device by Biolux Lic# 77929 (Approved by Health Canada)
Intervention Description
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 Measure Information:
Title
Implant stability
Description
Implant stability and bone quality will be assessed via RFA technology using Ostelle device (Resonance Frequency Analysis technology)
Time Frame
Immediately post-op, 1, 2, 4, and 8 weeks
Secondary Outcome Measure Information:
Title
Post-op analgesics
Description
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
Time Frame
Every 3 hours the day of the surgery post-op, then every morning, and at bed time for the following 7 days

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mahdi Ghuloom, DDS
Phone
+14169958897
Email
mahdidds@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cameron Clokie, DDS, FRCS
Organizational Affiliation
University of Toronto/Mount Sinai Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Mount Sinai Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahdi Ghuloom, DDS
Phone
+14169958897
Email
mahdidds@gmail.com
First Name & Middle Initial & Last Name & Degree
Cameron Clokie, DDS, FRCS
First Name & Middle Initial & Last Name & Degree
Mahdi Ghuloom, DDS

12. IPD Sharing Statement

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

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