Dental Implant HealingNCT03362307
Can Combination of Low-Level Laser and Light-Emitting Diodes Enhance Stability of Dental Implants?
A study testing Low-Level Laser and Light-Emitting Diodes and Dental implant placement in people with Dental Implant Healing, run by Shiraz University of Medical Sciences.
Trial summary
Subjects were assigned in two groups: In group 1, subjects received LLL and LED 20 min/day for 10 days after implant insertion, subjects in group 2did not undergo LLL and LED. implant stability quotients(ISQs) were measured in 0,10,21,42 and 63 days after implant placement. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Implant Healing
- What is being tested?
- Low-Level Laser and Light-Emitting Diodes and Dental implant placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 30 Sep 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- subjects eligible for study inclusion had an edentulous area at the first molar of the mandible and needed a dental implant
Who cannot join
- . Subjects were excluded from study enrollment if they had any diseases that affect bone, smoking, insufficient bone in the edentulous area which needs bone augmentation, failed to return for follow-up, or refused study enrollment.
About this study
Official title: Use Low-Level Laser and Light-Emitting Diodes in Dental Implants
Subjects were assigned in two groups: In group 1, subjects received LLL and LED 20 min/day for 10 days after implant insertion, subjects in group 2did not undergo LLL and LED. implant stability quotients(ISQs) were measured in 0,10,21,42 and 63 days after implant placement.
Read the detailed description
Subjects eligible for study inclusion had an edentulous area at the first molar of the mandible and needed a dental implant. Subjects were excluded from study enrollment if they had any diseases that affect bone, smoking, insufficient bone in the edentulous area which needs bone augmentation, failed to return for follow-up, or refused study enrollment.
All implants were placed at least 3 months after tooth removal. The size of implants was 4.8X 10 mm (Zimmer, USA) Subjects were aligned based on computer randomization in two groups: In group 1(intervention), subjects received LLL and LED after implant placement and in group 2 (control) the same device was used while device was off.
A portable device was applied for irradiation of the intervention group with combination of 810nm laser and 632nm LED.
Subjects in group 1 underwent LLL 15 mw/cm2 and LED 10 mw/cm2 20 min every day for 10 days.
The mesiodistal and buccolingual directions were measured and the mean implant stability quotients (ISQs) were determined. The RFA measurements were performed in immediate after insertion (time0) 10 days (time1), 3 weeks (time2), 6 weeks(time3) and 9(time 4) weeks after implant placement.
- Conditions
- Dental Implant Healing
- Being tested
- Low-Level Laser and Light-Emitting Diodes, Dental implant placement
- Keywords
- Low-Level Light Therapy, Osseointegration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Level Laser and Light-Emitting DiodesDevice
Combination of Low-Level Laser and Light-Emitting Diodes were used after dental implant placement for enhancement of stability
Dental implant placementDevice
A dental implant with 4.8X 10 mm (Zimmer, USA) size was placed at the posterior of the mandible
| Study group | Role | What they receive |
|---|---|---|
| Laser Emitting group | Active comparator | subjects received Low-Level Laser and Light-Emitting Diodes after implant placement Receives: Device: Low-Level Laser and Light-Emitting Diodes; Device: Dental implant placement |
| Non Emitting group | Placebo comparator | In laser emitiiing group, subjects received Low-Level Laser and Light-Emitting Diodes after implant placement and in Non-emitting group,the same device was used while device was off. Receives: Device: Low-Level Laser and Light-Emitting Diodes; Device: Dental implant placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resonance frequency analysis
The stability of the implants was evaluated with resonance frequency analysis by the Osstell device
Measured: Immidate after implant placement (time 0)
Resonance frequency analysis
The stability of the implants was evaluated with resonance frequency analysis by the Osstell device
Measured: 10 days (time1) after implant placement
Resonance frequency analysis
The stability of the implants was evaluated with resonance frequency analysis by the Osstell device
Measured: Three weeks after implant placement (time 2)
Resonance frequency analysis
The stability of the implants was evaluated with resonance frequency analysis by the Osstell device
Measured: Six weeks after implant placement (time 3)
Resonance frequency analysis
The stability of the implants was evaluated with resonance frequency analysis by the Osstell device
Measured: Nine weeks after implant placement(time 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2017
- Study start1 Jan 2014
- Primary completion1 Jan 2015
- Study completion30 Sep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental Implant HealingStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects were aligned based on computer randomization in two groups: In group 1(intervention), subjects received LLL and LED after implant placement and in group 2 (control) the same device was used while device was off.
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Shahid Beheshti University of Medical Sciences
- Responsible party
- Principal investigator, Reza Tabrizi, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03362307
- Sponsor's protocol ID
- Fr1396
- Status last verified
- Dec 2017
- First submitted
- 28 Nov 2017
- Last updated
- 5 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use Low-Level Laser and Light-Emitting Diodes in Dental Implants
- ClinicalTrials.gov ID
- NCT03362307
- Acronym / sponsor ID
- Fr1396
- Conditions
- Dental Implant Healing
- Keywords
- Low-Level Light Therapy, Osseointegration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Collaborators
- Shahid Beheshti University of Medical Sciences
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 1 Jan 2015 (actual)
- Study completion
- 30 Sep 2015 (actual)
- First posted
- 5 Dec 2017 (actual)
- 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.
Subjects were assigned in two groups: In group 1, subjects received LLL and LED 20 min/day for 10 days after implant insertion, subjects in group 2did not undergo LLL and LED. implant stability quotients(ISQs) were measured in 0,10,21,42 and 63 days after implant placement.
Detailed description
Subjects eligible for study inclusion had an edentulous area at the first molar of the mandible and needed a dental implant. Subjects were excluded from study enrollment if they had any diseases that affect bone, smoking, insufficient bone in the edentulous area which needs bone augmentation, failed to return for follow-up, or refused study enrollment.
All implants were placed at least 3 months after tooth removal. The size of implants was 4.8X 10 mm (Zimmer, USA) Subjects were aligned based on computer randomization in two groups: In group 1(intervention), subjects received LLL and LED after implant placement and in group 2 (control) the same device was used while device was off.
A portable device was applied for irradiation of the intervention group with combination of 810nm laser and 632nm LED.
Subjects in group 1 underwent LLL 15 mw/cm2 and LED 10 mw/cm2 20 min every day for 10 days.
The mesiodistal and buccolingual directions were measured and the mean implant stability quotients (ISQs) were determined. The RFA measurements were performed in immediate after insertion (time0) 10 days (time1), 3 weeks (time2), 6 weeks(time3) and 9(time 4) weeks after implant placement.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Subjects were aligned based on computer randomization in two groups: In group 1(intervention), subjects received LLL and LED after implant placement and in group 2 (control) the same device was used while device was off.
| Arm | Type | Receives |
|---|---|---|
| Laser Emitting group | Active comparator | Device: Low-Level Laser and Light-Emitting Diodes, Device: Dental implant placementsubjects received Low-Level Laser and Light-Emitting Diodes after implant placement |
| Non Emitting group | Placebo comparator | Device: Low-Level Laser and Light-Emitting Diodes, Device: Dental implant placementIn laser emitiiing group, subjects received Low-Level Laser and Light-Emitting Diodes after implant placement and in Non-emitting group,the same device was used while device was off. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- subjects eligible for study inclusion had an edentulous area at the first molar of the mandible and needed a dental implant
Key exclusion criteria (1 listed)
- . Subjects were excluded from study enrollment if they had any diseases that affect bone, smoking, insufficient bone in the edentulous area which needs bone augmentation, failed to return for follow-up, or refused study enrollment.
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 |
|---|---|---|
| Low-Level Laser and Light-Emitting DiodesCombination of Low-Level Laser and Light-Emitting Diodes were used after dental implant placement for enhancement of stability | Device | Laser Emitting group, Non Emitting group |
| Dental implant placementA dental implant with 4.8X 10 mm (Zimmer, USA) size was placed at the posterior of the mandible | Device | Laser Emitting group, Non Emitting group |
Primary outcome
Resonance frequency analysis
Time frame: Immidate after implant placement (time 0)
The stability of the implants was evaluated with resonance frequency analysis by the Osstell device
Resonance frequency analysis
Time frame: 10 days (time1) after implant placement
The stability of the implants was evaluated with resonance frequency analysis by the Osstell device
Resonance frequency analysis
Time frame: Three weeks after implant placement (time 2)
The stability of the implants was evaluated with resonance frequency analysis by the Osstell device
Resonance frequency analysis
Time frame: Six weeks after implant placement (time 3)
The stability of the implants was evaluated with resonance frequency analysis by the Osstell device
Resonance frequency analysis
Time frame: Nine weeks after implant placement(time 4)
The stability of the implants was evaluated with resonance frequency analysis by the Osstell device
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2017.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Low-Level Laser and Light-Emitting Diodes and Dental implant placement in people with Dental Implant Healing, run by Shiraz University of Medical Sciences.
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 1 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: finished, as of the sponsor's last update on 5 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Resonance frequency analysis (time frame: Immidate after implant placement (time 0)). The study lists 5 primary outcomes in all. 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 5 Dec 2017.