Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04175405
Other study ID # WroclawMU2212
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 6, 2019
Est. completion date October 24, 2019

Study information

Verified date November 2019
Source Wroclaw Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date October 24, 2019
Est. primary completion date June 2, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Irradiation of implants with 635nm laser
Irradiation of implants with 635nm laser with a dose of 10J

Locations

Country Name City State
Poland Private Dental Healtcare Wschowa

Sponsors (1)

Lead Sponsor Collaborator
Wroclaw Medical University

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 60 days
Secondary 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. 24 hours
Secondary mini-implants loss 60 days
See also
  Status Clinical Trial Phase
Recruiting NCT06297109 - Maxillary Patient Specific Implants in Bimaxillary Orthognathic Surgery N/A
Recruiting NCT05227469 - Myofunctional Therapy Twin Block N/A
Completed NCT05356780 - Predictability of Orthodontic Tooth Movement With Invisalign Aligners
Not yet recruiting NCT05467579 - Mandibular Advancement Clear Aligner Treatment in Juvenile Idiopathic Arthritis Subjects N/A
Completed NCT01530516 - Crossbow Versus Forsus Springs in Mild to Moderate Class II Malocclusion Cases N/A
Recruiting NCT04875104 - Upper Sequential Distalization With TADs and Aligners N/A
Not yet recruiting NCT05853211 - Therapeutic Effects of Class II Elastics on Aligners in Different Vertical Skelettal Patterns
Completed NCT02456220 - Dentoskeletal Changes Associated With Herbst Appliance Therapy N/A
Recruiting NCT05950581 - Treatment of Skeletal Class II Malocclusion With Modified Twin-Block Appliance With Clear Plates N/A
Completed NCT03645343 - The Effect of Functional Treatment of Patients With Backward Positioned Chins on the Jaw Joint and Movements N/A
Completed NCT04276402 - Effect of Photobiomodulation by 808nm Diode Laser on the Stability of Orthodontic Mini-implants. N/A
Completed NCT03239912 - Treatment of Class II Malocclusion Combined With Low-level Laser N/A
Recruiting NCT03773783 - Study to Compare Two Functional Appliances for Class II Malocclusions N/A
Recruiting NCT05499221 - Bone Anchored Carriere Motion Appliance N/A
Completed NCT03159962 - Mandibular Response After Maxillary Orthopedic Expansion in Class II Growing Subjects N/A
Active, not recruiting NCT02010346 - The Effect of Timing on Orthodontic Treatment N/A
Completed NCT06240923 - "Three Dimensional Assessment of Maxillary Molars Following Distalization Using Two Different Approaches" N/A
Completed NCT05298280 - Vertical Effects in Class II Patients Treated With Distalization N/A
Completed NCT04556448 - RCT Comparing Invisalign and Traditional Orthodontic Treatment N/A
Completed NCT03455634 - Predictors Associated With Seeking Orthodontic Treatment, Compliance and Treatment Success N/A