NCT03362307

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2014

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2015

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 5, 2017

Completed
Last Updated

December 5, 2017

Status Verified

December 1, 2017

Enrollment Period

1 year

First QC Date

November 28, 2017

Last Update Submit

December 3, 2017

Conditions

Keywords

Low-Level Light Therapy, Osseointegration

Outcome Measures

Primary Outcomes (5)

  • Resonance frequency analysis

    The stability of the implants was evaluated with resonance frequency analysis by the Osstell device

    Immidate after implant placement (time 0)

  • Resonance frequency analysis

    The stability of the implants was evaluated with resonance frequency analysis by the Osstell device

    10 days (time1) after implant placement

  • Resonance frequency analysis

    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

    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

    The stability of the implants was evaluated with resonance frequency analysis by the Osstell device

    Nine weeks after implant placement(time 4)

Study Arms (2)

Laser Emitting group

ACTIVE COMPARATOR

subjects received Low-Level Laser and Light-Emitting Diodes after implant placement

Device: Low-Level Laser and Light-Emitting DiodesDevice: 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.

Device: Low-Level Laser and Light-Emitting DiodesDevice: Dental implant placement

Interventions

Combination of Low-Level Laser and Light-Emitting Diodes were used after dental implant placement for enhancement of stability

Laser Emitting groupNon Emitting group

A dental implant with 4.8X 10 mm (Zimmer, USA) size was placed at the posterior of the mandible

Laser Emitting groupNon Emitting group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate Professor

Study Record Dates

First Submitted

November 28, 2017

First Posted

December 5, 2017

Study Start

January 1, 2014

Primary Completion

January 1, 2015

Study Completion

September 30, 2015

Last Updated

December 5, 2017

Record last verified: 2017-12