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Photobiomodulation

PBM Ortho Active device for Orthodontics

N/A

Recruiting

Research Sponsored by PBM Healing International Limited

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Systemically healthy male and female patients (age 20 to 65), i.e., do not suffer from systemic illness nor require medication during the saliva collection period.

No sign of periodontal disease.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 7

Awards & highlights

Study Summary

This trial will test whether a photobiomodulation device can reduce pain in people undergoing clear aligners orthodontic treatment.

Who is the study for?

Adults aged 20-65 with misaligned teeth who are getting clear aligners and have good oral health can join this trial. They must not smoke, have no cavities or gum disease, and cannot be on medications that might affect saliva during the study.Check my eligibility

What is being tested?

The trial is testing PBM Ortho, a light therapy device, to see if it reduces pain associated with orthodontic treatment using clear aligners. Pain levels will be measured by what patients report and through saliva samples before and after aligner placement.See study design

What are the potential side effects?

Since PBM Ortho uses light without drugs or surgery, side effects are expected to be minimal. However, specific side effect information isn't provided in the given details.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 20 and 65 years old and do not have any chronic illnesses or need medication.

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I do not have gum disease.

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I do not have any cavities.

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I am undergoing orthodontic treatment with clear aligners without tooth removal.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 7

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 7

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 7 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Visual analog scale

Secondary outcome measures

Saliva

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: PBM Ortho Active deviceActive Control1 Intervention

PBM Ortho Active group will be given an active device.

Group II: PBM Ortho ShamPlacebo Group1 Intervention

PBM Ortho Sham device group will be given a non-active device that will not emits light.

0 / 4Eligibility criteria met

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Who is running the clinical trial?

PBM Healing International LimitedLead Sponsor

1 Previous Clinical Trials

32 Total Patients Enrolled

1 Trials studying Orthodontics

32 Patients Enrolled for Orthodontics

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research experiment currently enrolling participants?

"According to information presented on clinicaltrials.gov, this medical study is not currently admitting candidates for participation. Initially posted in January of 2023 and last updated on September 28th 2022, the trial has entered a period of dormancy; however, there are 48 other active trials that require volunteers."

Answered by AI

Does this experiment accommodate participants who are over thirty years of age?

"This medical trial mandates that participants are aged between 20 and 65."

Answered by AI

Do I meet the criteria to participate in this medical research?

"This clinical trial is presently recruiting 50 individuals (males and females aged 20 to 65) presenting with crossbite. Subsequently, these potential participants must meet the following criteria: no systemic illness nor need for medication during study period; permanent dentition with Little's Irregularity Index of 2mm or greater in upper and lower arch; orthodontic treatment using clear aligners without extraction therapy available; willing and able to comply with protocol requirements; non-smoker/chewing tobacco abstainer; good oral hygiene status free from caries & periodontal disease."

Answered by AI

Recent research and studies

International Journal of Oral ScienceJournal

Current Advances in Orthodontic Pain

Long, Hu, Yan Wang, Fan Jian, Li-Na Liao, Xin Yang, and Wen-Li Lai. 2016. “Current Advances in Orthodontic Pain”. International Journal of Oral Science. Springer Science and Business Media LLC. doi:10.1038/ijos.2016.24.

European Journal of Oral SciencesJournal

Cytokines in Crevicular Fluid and Orthodontic Tooth Movement

Ren, Yijin, and Arjan Vissink. 2008. “Cytokines in Crevicular Fluid and Orthodontic Tooth Movement”. European Journal of Oral Sciences. Wiley. doi:10.1111/j.1600-0722.2007.00511.x.

International Journal of Oral ScienceJournal

Effect of Low-level Laser Therapy on Tooth-related Pain and Somatosensory Function Evoked by Orthodontic Treatment

Wu, Song, Yinan Chen, Jinglu Zhang, Wenjing Chen, Sheng Shao, Huijie Shen, Ling Zhu, Ping Ye, Peter Svensson, and Kelun Wang. 2018. “Effect of Low-level Laser Therapy on Tooth-related Pain and Somatosensory Function Evoked by Orthodontic Treatment”. International Journal of Oral Science. Springer Science and Business Media LLC. doi:10.1038/s41368-018-0023-0.

The Angle OrthodontistJournal