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

NCT ID: NCT03362307

Last Updated: 2017-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-01

Study Completion Date

2015-09-30

Brief Summary

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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

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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.

Conditions

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Dental Implant Healing

Keywords

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Low-Level Light Therapy, Osseointegration

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Laser Emitting group

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

Group Type ACTIVE_COMPARATOR

Low-Level Laser and Light-Emitting Diodes

Intervention Type DEVICE

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

Dental implant placement

Intervention Type DEVICE

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

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.

Group Type PLACEBO_COMPARATOR

Low-Level Laser and Light-Emitting Diodes

Intervention Type DEVICE

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

Dental implant placement

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Dental implant placement

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role collaborator

Shiraz University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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Reza Tabrizi

associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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Fr1396

Identifier Type: -

Identifier Source: org_study_id