Back to resultsLow-level Laser Therapy With a 635nm Diode Laser on Orthodontic Mini-implants Stability.
Primary Purpose
Malocclusion, Angle Class II
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Irradiation of implants with 635nm laser
Sponsored by
About this trial
This is an interventional treatment trial for Malocclusion, Angle Class II focused on measuring ATP, biostimulation, micro-screw, Periotest, semiconductor laser
Eligibility Criteria
Inclusion Criteria:
- patients with class II malocclusion defect requiring lateral maxillary teeth distillation based on the use of orthodontic mini-implant;
- the patients were treated first time using fixed orthodontic appliance;
- no systemic diseases;
- were not using anti-inflammatory drugs;
Exclusion Criteria:
- had used antibiotics in the previous 24 months;
- smokers;
- had history of radiotherapy,
- taking bisphosphonate medication
Sites / Locations
- Private Dental Healtcare
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Right side of the maxilla
Left side of the maxilla
Arm Description
The 635-nm laser parameters; dose: 10J per point (20J/cm2), time: 100 sec per point, 2 points (irradiation on a buccal, and a palatal side of the alveolus/implant), the total energy per session 20J.
Outcomes
Primary Outcome Measures
stability of orthodontic mini-implants
The mini-implants stability was estimated employing a Periotest device (Medzintechnik Gulden e K, Modautal, Germany). The Periotest measurement system includes the sound formed from contact between an object and a metallic tapping bar in a handpiece, which is electromagnetically driven and electronically verified. The Periotest response detection is analyzed through a fast Fourier transform (FFT) algorithm. Simply put, the Periotest answer to tapping is estimated by an accelerometer and then analyzed. The signal generated by tapping is then transformed to a value called the Periotest value (PTV), which depends on the damping characteristics of the peri-implant tissue. [27] The Periotest Test values (PTVs) are based on a numerical scale ranging from -8 to +50, defined by mathematical computation. The lower Periotest values indicate higher implant stability and thereupon the higher absorption effect of the target objects.
Secondary Outcome Measures
Pain level
Immediately after the mini-implants placement, each patient received a questionnaire for individual pain assessment (the numeric rating scale, NRS-11, grade level 0-10). The maximum pain level was measured at both sides of the maxilla during the first day after the treatment. The NRS-11 scale consists of a conscious, subjective assessment of the pain experienced; therefore, it is used in the case of patients over ten years old. A rating of 0 signifies no pain, 1-3 represents mild pain, 4-6 moderate pain, and 7-10 severe pain.
mini-implants loss
Full Information
NCT ID
NCT04175405
First Posted
November 21, 2019
Last Updated
November 21, 2019
Sponsor
Wroclaw Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04175405
Brief Title
Low-level Laser Therapy With a 635nm Diode Laser on Orthodontic Mini-implants Stability.
Official Title
Low-level Laser Therapy With a 635nm Diode Laser Affects Orthodontic Mini-implants Stability. A Randomized Clinical Split-Mouth Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
March 6, 2019 (Actual)
Primary Completion Date
June 2, 2019 (Actual)
Study Completion Date
October 24, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Wroclaw Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study aimed to clinically estimate an influence of a 635nm diode laser on the primary and secondary stability of orthodontic mini-implants placed in a maxilla, to assess mini-implants failure rate (mini-implant loss) and to evaluate a pain level after the treatment. The randomized clinical split-mouth trial included 15 subjects, 30 implants (Dual Top Anchor System, Seoul, Korea) with a diameter 1.4mm and length of 10mm. Mini-implants were placed in the area of the attached gingiva between the second premolar and first molar teeth 2 mm below the mucogingival junction of both sides of the maxilla in 20 patients (13 women and 7 men; age: 32.5 ± 6.1 years).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Angle Class II
Keywords
ATP, biostimulation, micro-screw, Periotest, semiconductor laser
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Right side of the maxilla
Arm Type
Experimental
Arm Description
The 635-nm laser parameters; dose: 10J per point (20J/cm2), time: 100 sec per point, 2 points (irradiation on a buccal, and a palatal side of the alveolus/implant), the total energy per session 20J.
Arm Title
Left side of the maxilla
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Irradiation of implants with 635nm laser
Intervention Description
Irradiation of implants with 635nm laser with a dose of 10J
Primary Outcome Measure Information:
Title
stability of orthodontic mini-implants
Description
The mini-implants stability was estimated employing a Periotest device (Medzintechnik Gulden e K, Modautal, Germany). The Periotest measurement system includes the sound formed from contact between an object and a metallic tapping bar in a handpiece, which is electromagnetically driven and electronically verified. The Periotest response detection is analyzed through a fast Fourier transform (FFT) algorithm. Simply put, the Periotest answer to tapping is estimated by an accelerometer and then analyzed. The signal generated by tapping is then transformed to a value called the Periotest value (PTV), which depends on the damping characteristics of the peri-implant tissue. [27] The Periotest Test values (PTVs) are based on a numerical scale ranging from -8 to +50, defined by mathematical computation. The lower Periotest values indicate higher implant stability and thereupon the higher absorption effect of the target objects.
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Pain level
Description
Immediately after the mini-implants placement, each patient received a questionnaire for individual pain assessment (the numeric rating scale, NRS-11, grade level 0-10). The maximum pain level was measured at both sides of the maxilla during the first day after the treatment. The NRS-11 scale consists of a conscious, subjective assessment of the pain experienced; therefore, it is used in the case of patients over ten years old. A rating of 0 signifies no pain, 1-3 represents mild pain, 4-6 moderate pain, and 7-10 severe pain.
Time Frame
24 hours
Title
mini-implants loss
Time Frame
60 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
patients with class II malocclusion defect requiring lateral maxillary teeth distillation based on the use of orthodontic mini-implant;
the patients were treated first time using fixed orthodontic appliance;
no systemic diseases;
were not using anti-inflammatory drugs;
Exclusion Criteria:
had used antibiotics in the previous 24 months;
smokers;
had history of radiotherapy,
taking bisphosphonate medication
Facility Information:
Facility Name
Private Dental Healtcare
City
Wschowa
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
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Low-level Laser Therapy With a 635nm Diode Laser on Orthodontic Mini-implants Stability.
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