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Effect of Photobiomodulation by 808nm Diode Laser on the Stability of Orthodontic Mini-implants.

Primary Purpose

Malocclusion, Angle Class II

Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Irradiation of implants with 808nm 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

Eligibility Criteria

18 Years - 60 Years (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

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. 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 (NRS scale)
Each patient received a questionnaire for individual pain assessment (the numeric rating scale, NRS-11, grade level 0-10) immediately following placement of mini-implants. 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. 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain.
mini-implants loss
Mini-implants survival rate was assessed during 60 days observation period.

Full Information

First Posted
February 14, 2020
Last Updated
February 17, 2020
Sponsor
Wroclaw Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04276402
Brief Title
Effect of Photobiomodulation by 808nm Diode Laser on the Stability of Orthodontic Mini-implants.
Official Title
Effect of Photobiomodulation by 808nm Diode Laser on the Stability of Orthodontic Mini-implants: A Randomized Clinical Split-Mouth Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
July 5, 2019 (Actual)
Primary Completion Date
October 12, 2019 (Actual)
Study Completion Date
November 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

5. Study Description

Brief Summary
The study aimed to evaluate the influence of a 635nm diode laser on the stability of orthodontic mini-implants in vitro, as well as mini-implants failure rate (mini-implant loss) and patients pain level after the treatment. A randomized clinical split-mouth trial was concluded with 22 subjects (14 women, 8 men), 44 orthodontic mini-implants with a diameter 1.4mm and length of 10mm. Mini-implants were placed between teeth 3 and 4; and 13 and 14 (Universal Numbering System), in the area of the attached gingiva, 2 mm below mucogingival junction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malocclusion, Angle Class II

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Right side of the maxilla
Arm Type
Experimental
Arm Title
Left side of the maxilla
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Irradiation of implants with 808nm laser
Intervention Description
Irradiation of implants with 808nm 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. 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 (NRS scale)
Description
Each patient received a questionnaire for individual pain assessment (the numeric rating scale, NRS-11, grade level 0-10) immediately following placement of mini-implants. 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. 0 = no pain, 1-3 = mild pain, 4-6 = moderate pain, 7-10 = severe pain.
Time Frame
24 hours
Title
mini-implants loss
Description
Mini-implants survival rate was assessed during 60 days observation period.
Time Frame
60 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
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
Kościan
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of Photobiomodulation by 808nm Diode Laser on the Stability of Orthodontic Mini-implants.

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