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Photobiomodulation of Orthodontic Mini-implants by a 635nm Diode Laser

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
Wroclaw Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 right side of the maxilla

left side of the maxilla

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

Full Information

First Posted
November 14, 2019
Last Updated
November 17, 2019
Sponsor
Wroclaw Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04170127
Brief Title
Photobiomodulation of Orthodontic Mini-implants by a 635nm Diode Laser
Official Title
Photobiomodulation of Orthodontic Mini-implants by a 635nm Diode Laser: Primary and Secondary 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
February 2, 2019 (Actual)
Primary Completion Date
May 12, 2019 (Actual)
Study Completion Date
August 2, 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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study aimed to estimate clinically an influence of 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 15 patients.

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
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Right side of the maxilla
Arm Type
Experimental
Arm Description
the right side of the maxilla
Arm Title
Left side of the maxilla
Arm Type
No Intervention
Arm Description
left side of the maxilla
Intervention Type
Procedure
Intervention Name(s)
Irradiation of implants with 635nm laser
Intervention Description
Irradiation of implants with 635nm laser
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
Other Pre-specified Outcome Measures:
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
Gender Based
Yes
Gender Eligibility Description
10 women and 5 man
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

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Photobiomodulation of Orthodontic Mini-implants by a 635nm Diode Laser

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