Skip to main content
OpenTrials
Completed

NCT Number: NCT04276402

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Malocclusion, Angle Class II Malocclusion Stomatognathic Diseases Tooth Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Private Dental Healtcare

Kościan, Poland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Irradiation of implants with 808nm laser

Procedure

Irradiation of implants with 808nm laser

Primary outcomes

  1. stability of orthodontic mini-implants

    Time frame: 60 days

    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 outcomes

  1. Pain level (NRS scale)

    Time frame: 24 hours

    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.

  2. mini-implants loss

    Time frame: 60 days

    Mini-implants survival rate was assessed during 60 days observation period.

Sponsors and collaborators

Lead sponsor

Wroclaw Medical University

Other

Registry information

Official study title

Effect of Photobiomodulation by 808nm Diode Laser on the Stability of Orthodontic Mini-implants: A Randomized Clinical Split-Mouth Trial.

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 19, 2020
Registry last updated
Feb 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.