Can Combination of Low-Level Laser and Light-Emitting Diodes Enhance Stability of Dental Implants?

December 3, 2017 updated by: Reza Tabrizi, Shiraz University of Medical Sciences

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • subjects eligible for study inclusion had an edentulous area at the first molar of the mandible and needed a dental implant

Exclusion Criteria:

  • . 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: Laser Emitting group
subjects received Low-Level Laser and Light-Emitting Diodes after implant placement
Device: Low-Level Laser and Light-Emitting Diodes
Combination of Low-Level Laser and Light-Emitting Diodes were used after dental implant placement for enhancement of stability
Device: Dental implant placement
A dental implant with 4.8X 10 mm (Zimmer, USA) size was placed at the posterior of the mandible
PLACEBO_COMPARATOR: Non Emitting group
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.
Device: Low-Level Laser and Light-Emitting Diodes
Combination of Low-Level Laser and Light-Emitting Diodes were used after dental implant placement for enhancement of stability
Device: Dental implant placement
A dental implant with 4.8X 10 mm (Zimmer, USA) size was placed at the posterior of the mandible

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Immidate after implant placement (time 0)
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
10 days (time1) after implant placement
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
Three weeks after implant placement (time 2)
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
Six weeks after implant placement (time 3)
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
Nine weeks after implant placement(time 4)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shiraz University of Medical Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Shahid Beheshti University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2014

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2015

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 28, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 5, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 5, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Fr1396

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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