- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05739838
Low-Level Laser Effects on Orthodontic Tooth Movement of Periodontally Compromised Patients.
February 23, 2023 updated by: Faculty of Dental Medicine for Girls
Low-Level Laser Effects on Orthodontic Tooth Movement of Periodontally Compromised Patients. Clinical and Biochemical Study
To investigate the effect of Low Level Laser therapy on orthodontic tooth movement of periodontally compromised patients by evaluating the rate of orthodontic tooth movement and the level of Osteocalcin in the gingival crevicular fluid.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Detailed Description
Low-Level laser therapy has been reported as an effective adjunct to non surgical periodontal treatment for inflammation control and tissue reparation in patients with periodontitis.
Previous studies have shown that application of low-level laser therapy reduced pocket depth and decreased the inflammatory process through regulatory control of inflammatory cytokines level, therefore this study will investigate the effect of low-level laser on the periodontal tissue .Accelerating orthodontic tooth movement is one of the primary demand in orthodontics to prevent side effects as root resorption, caries and decreased patient compliance .
Numerous researchers have also studied the use of LLLT in accelerating orthodontic tooth movement and have considered the laser to be effective while others achieved the opposite .
Hence, This study is aiming to investigate the effects of LLLT in accelerating tooth movement.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Cairo, Egypt, 002
- Faculty of dental medicine for Girls, AL Azhar University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- No systemic disease.
- No history medication (antibiotics and/or anti inflammatory) in the previous 4 months.
- Self motivated patients with acceptable oral hygien.
Exclusion Criteria:
- Previous orthodontic treatment
- Aggressive periodontitis
- Smokers
- pregnant patients
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Periodontally compromised patients subjected to low level laser therapy
periodontally compromised patients with pocket depth of more than 5 mm before receiving nonsurgical periodontal treatment treatment or/and pocket depth of less than 4 mm with periodontal status identified as stable for at least 3 month after nonsurgical periodontal treatment subjected to low-level laser of 940 nm will be applied at day one after start of treatment , weekly during the first month, then monthly.
|
Low Level laser ,940 nm
Other Names:
|
|
No Intervention: Periodontally compromised patients
periodontally compromised patients with pocket depth of more than 5 mm before receiving nonsurgical periodontal treatment treatment or/and pocket depth of less than 4 mm with periodontal status identified as stable for at least 3 month after nonsurgical periodontal treatment.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Rate of orthodontic tooth movement
Time Frame: 6 months
|
Rate of mandibular canine retraction
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Osteocalcin level in GCF
Time Frame: 6 months
|
Gingival Crevicular Fluid samples will be collected from al target teeth in both groups to detect osteocalcin level after start of orthodontic treatment and at the end of the study
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Mohsena A Abdelrazek, Lecturer, Lecturer of Orthodontic department faculty of Dental medicine for Girls AL-azhar University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2021
Primary Completion (Anticipated)
April 1, 2023
Study Completion (Anticipated)
May 1, 2023
Study Registration Dates
First Submitted
February 13, 2023
First Submitted That Met QC Criteria
February 13, 2023
First Posted (Actual)
February 22, 2023
Study Record Updates
Last Update Posted (Actual)
February 24, 2023
Last Update Submitted That Met QC Criteria
February 23, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ORTHO-108-6-J
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Investigate the effect of low level laser on orthodontic tooth movement of periodontally compromised patients, by evaluating the rate of orthodontic tooth movement and the level of osteocalcin in Gingival crevicular fluid
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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