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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

Tracking Information
First Submitted Date  ICMJE November 28, 2017
First Posted Date  ICMJE December 5, 2017
Last Update Posted Date December 5, 2017
Actual Study Start Date  ICMJE January 1, 2014
Actual Primary Completion Date January 1, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 3, 2017)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Can Combination of Low-Level Laser and Light-Emitting Diodes Enhance Stability of Dental Implants?
Official Title  ICMJE Use Low-Level Laser and Light-Emitting Diodes in Dental Implants
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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Dental Implant Healing
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Active Comparator: Laser Emitting group
    subjects received Low-Level Laser and Light-Emitting Diodes after implant placement
    Interventions:
    • Device: Low-Level Laser and Light-Emitting Diodes
    • Device: Dental implant placement
  • 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.
    Interventions:
    • Device: Low-Level Laser and Light-Emitting Diodes
    • Device: Dental implant placement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 3, 2017)
28
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 30, 2015
Actual Primary Completion Date January 1, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03362307
Other Study ID Numbers  ICMJE Fr1396
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Reza Tabrizi, Shiraz University of Medical Sciences
Study Sponsor  ICMJE Shiraz University of Medical Sciences
Collaborators  ICMJE Shahid Beheshti University of Medical Sciences
Investigators  ICMJE Not Provided
PRS Account Shiraz University of Medical Sciences
Verification Date December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP