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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03362307
Recruitment Status : Completed
First Posted : December 5, 2017
Last Update Posted : December 5, 2017
Sponsor:
Collaborator:
Shahid Beheshti University of Medical Sciences
Information provided by (Responsible Party):
Reza Tabrizi, Shiraz University of Medical Sciences

Brief 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.

Condition or disease Intervention/treatment Phase
Dental Implant Healing Device: Low-Level Laser and Light-Emitting Diodes Device: Dental implant placement Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Other
Official Title: Use Low-Level Laser and Light-Emitting Diodes in Dental Implants
Actual Study Start Date : January 1, 2014
Actual Primary Completion Date : January 1, 2015
Actual Study Completion Date : September 30, 2015

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
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Responsible Party: Reza Tabrizi, associate Professor, Shiraz University of Medical Sciences
ClinicalTrials.gov Identifier: NCT03362307    
Other Study ID Numbers: Fr1396
First Posted: December 5, 2017    Key Record Dates
Last Update Posted: December 5, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Reza Tabrizi, Shiraz University of Medical Sciences:
Low-Level Light Therapy, Osseointegration