Clinical trial NCT03362307: Can Combination of Low-Level Laser and Light-Emitting Diodes Enhance Stability of Dental Implants?
Official title: Use Low-Level Laser and Light-Emitting Diodes in Dental Implants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dental Implant Healing
Keywords: Low-Level Light Therapy, Osseointegration
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
Collaborators: name: Shahid Beheshti University of Medical Sciences
First posted: 2017-12-05
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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.

Eligibility 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.

Primary outcomes:
measure: Resonance frequency analysis
timeFrame: Immidate after implant placement (time 0)
measure: Resonance frequency analysis
timeFrame: 10 days (time1) after implant placement
measure: Resonance frequency analysis
timeFrame: Three weeks after implant placement (time 2)
measure: Resonance frequency analysis
timeFrame: Six weeks after implant placement (time 3)
measure: Resonance frequency analysis
timeFrame: Nine weeks after implant placement(time 4)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: