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Low-Level Laser Effects on Orthodontic Tooth Movement of Periodontally Compromised Patients.

Sponsor
Faculty of Dental Medicine for Girls (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05739838
Collaborator
(none)
20
Enrollment
1
Location
2
Arms
25
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Biolase ;Low Level Laser
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
ten patients with periodontally affected teeth subjected to low level laser therapyten patients with periodontally affected teeth subjected to low level laser therapy
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Low-Level Laser Effects on Orthodontic Tooth Movement of Periodontally Compromised Patients. Clinical and Biochemical Study
Actual Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
May 1, 2023

Arms and Interventions

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.

Device: Biolase ;Low Level Laser
Low Level laser ,940 nm
Other Names:
  • Biolase

    		•
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Rate of orthodontic tooth movement [6 months]

      Rate of mandibular canine retraction

    Secondary Outcome Measures

    1. Osteocalcin level in GCF [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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 35 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of dental medicine for Girls, AL Azhar University Cairo Egypt 002

    Sponsors and Collaborators

    • Faculty of Dental Medicine for Girls

    Investigators

    • Study Director: Mohsena A Abdelrazek, Lecturer, Lecturer of Orthodontic department faculty of Dental medicine for Girls AL-azhar University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Faculty of Dental Medicine for Girls
    ClinicalTrials.gov Identifier:
    NCT05739838
    Other Study ID Numbers:
    • ORTHO-108-6-J
    First Posted:
    Feb 22, 2023
    Last Update Posted:
    Feb 24, 2023
    Last Verified:
    Feb 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Faculty of Dental Medicine for Girls
    Rate of orthodontic tooth movement
    Osteiocalsine
    Additional relevant MeSH terms:
    Periodontal Diseases

    Study Results

    No Results Posted as of Feb 24, 2023