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

Primary Purpose

Periodontal Diseases, Cancer Metastatic, Orthodontic Tooth Movement

Status
Active
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Biolase ;Low Level Laser
Sponsored by
Faculty of Dental Medicine for Girls
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Periodontal Diseases focused on measuring Rate of orthodontic tooth movement, Osteiocalsine

Eligibility Criteria

25 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Faculty of dental medicine for Girls, AL Azhar University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Periodontally compromised patients subjected to low level laser therapy

Periodontally compromised patients

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Rate of orthodontic tooth movement
Rate of mandibular canine retraction

Secondary Outcome Measures

Osteocalcin level in GCF
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

Full Information

First Posted
February 13, 2023
Last Updated
February 23, 2023
Sponsor
Faculty of Dental Medicine for Girls
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1. Study Identification

Unique Protocol Identification Number
NCT05739838
Brief Title
Low-Level Laser Effects on Orthodontic Tooth Movement of Periodontally Compromised Patients.
Official Title
Low-Level Laser Effects on Orthodontic Tooth Movement of Periodontally Compromised Patients. Clinical and Biochemical Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Faculty of Dental Medicine for Girls

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases, Cancer Metastatic, Orthodontic Tooth Movement
Keywords
Rate of orthodontic tooth movement, Osteiocalsine

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
ten patients with periodontally affected teeth subjected to low level laser therapy
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Periodontally compromised patients subjected to low level laser therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Periodontally compromised patients
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Biolase ;Low Level Laser
Other Intervention Name(s)
Biolase
Intervention Description
Low Level laser ,940 nm
Primary Outcome Measure Information:
Title
Rate of orthodontic tooth movement
Description
Rate of mandibular canine retraction
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Osteocalcin level in GCF
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mohsena A Abdelrazek, Lecturer
Organizational Affiliation
Lecturer of Orthodontic department faculty of Dental medicine for Girls AL-azhar University
Official's Role
Study Director
Facility Information:
Facility Name
Faculty of dental medicine for Girls, AL Azhar University
City
Cairo
ZIP/Postal Code
002
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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
Citations:
PubMed Identifier
31833004
Citation
Ren C, McGrath C, Gu M, Jin L, Zhang C, Sum FHKMH, Wong KWF, Chau ACM, Yang Y. Low-level laser-aided orthodontic treatment of periodontally compromised patients: a randomised controlled trial. Lasers Med Sci. 2020 Apr;35(3):729-739. doi: 10.1007/s10103-019-02923-0. Epub 2019 Dec 12.
Results Reference
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Low-Level Laser Effects on Orthodontic Tooth Movement of Periodontally Compromised Patients.

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