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

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: Completed
• Conditions: Dental Implant Healing
• Intervention / Treatment: Device: Low-Level Laser and Light-Emitting Diodes; Device: Dental 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: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: Shiraz University of Medical Sciences
• Collaborators: Shahid Beheshti University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2014
• Primary Completion (ACTUAL): January 1, 2015
• Study Completion (ACTUAL): September 30, 2015

Study Registration Dates

• First Submitted: November 28, 2017
• First Submitted That Met QC Criteria: December 3, 2017
• First Posted (ACTUAL): December 5, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 5, 2017
• Last Update Submitted That Met QC Criteria: December 3, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Low-Level Light Therapy, Osseointegration
• Other Study ID 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