ImplantNCT01097499
Low Level Laser (LED) Use to Increase Dental Implant Stability and Post Operative Analgesia
A study testing OsseoPulse device (Light emitting diode technology) in people with Implant and Analgesia, run by Mount Sinai Hospital, Canada at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- What is being tested?
- OsseoPulse device (Light emitting diode technology)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2010to Oct 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 1) English speaking
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
Mahdi Ghuloom, DDS, +14169958897, mahdidds@gmail.com
Cameron Clokie, DDS, FRCS
About this study
Official title: Role of Light Emitting Diode on Implant Stability, Bone Resorption and Analgesia Post Dental Implant Placement
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.
Read more
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).
- Being tested
- OsseoPulse device (Light emitting diode technology)
- Keywords
- Dental implant initial stability, Initial bone resorption post implant placement, Analgesia effect of LED intervention
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OsseoPulse device (Light emitting diode technology)Device
Also called Device by Biolux Lic# 77929 (Approved by Health Canada)
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.
| Study group | Role | What they receive |
|---|---|---|
| LED application | Active comparator | 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. Receives: Device: OsseoPulse device (Light emitting diode technology) |
| No LED application | No intervention | These patients will receive conventional dental implant treatment without the application of the LED therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant stability
Implant stability and bone quality will be assessed via RFA technology using Ostelle device (Resonance Frequency Analysis technology)
Measured: Immediately post-op, 1, 2, 4, and 8 weeks
Secondary outcomes (1)
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
Measured: Every 3 hours the day of the surgery post-op, then every morning, and at bed time for the following 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionAug 2010 (estimated)
- Study completionOct 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ImplantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Investigators
- Cameron Clokie, DDS, FRCS, Study director, University of Toronto/Mount Sinai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01097499
- Sponsor's protocol ID
- MSH-Biolux2010
- Status last verified
- Mar 2010
- First submitted
- 31 Mar 2010
- Last updated
- 1 Apr 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Light Emitting Diode on Implant Stability, Bone Resorption and Analgesia Post Dental Implant Placement
- ClinicalTrials.gov ID
- NCT01097499
- Acronym / sponsor ID
- MSH-Biolux2010
- Keywords
- Dental implant initial stability, Initial bone resorption post implant placement, Analgesia effect of LED intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Aug 2010 (estimated)
- Study completion
- Oct 2010 (estimated)
- First posted
- 1 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LED application | Active comparator | 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. |
| No LED application | No intervention | –These patients will receive conventional dental implant treatment without the application of the LED therapy. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 1) English speaking
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OsseoPulse device (Light emitting diode technology)Also: Device by Biolux Lic# 77929 (Approved by Health Canada)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 | LED application |
Primary outcome
Implant stability
Time frame: 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)
1 secondary outcome
Post-op analgesics
Time frame: Every 3 hours the day of the surgery post-op, then every morning, and at bed time for the following 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cameron Clokie, DDS, FRCS study director
University of Toronto/Mount Sinai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OsseoPulse device (Light emitting diode technology) in people with Implant and Analgesia, run by Mount Sinai Hospital, Canada at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Apr 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahdi Ghuloom, DDS (+14169958897, mahdidds@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant stability (time frame: Immediately post-op, 1, 2, 4, and 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2010.