NCT05739838

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2021

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 13, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 22, 2023

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2023

Completed
Last Updated

February 24, 2023

Status Verified

February 1, 2023

Enrollment Period

2 years

First QC Date

February 13, 2023

Last Update Submit

February 23, 2023

Conditions

Keywords

Rate of orthodontic tooth movementOsteiocalsine

Outcome Measures

Primary Outcomes (1)

  • Rate of orthodontic tooth movement

    Rate of mandibular canine retraction

    6 months

Secondary Outcomes (1)

  • Osteocalcin level in GCF

    6 months

Study Arms (2)

Periodontally compromised patients subjected to low level laser therapy

EXPERIMENTAL

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

Periodontally compromised patients

NO INTERVENTION

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.

Interventions

Low Level laser ,940 nm

Also known as: Biolase
Periodontally compromised patients subjected to low level laser therapy

Eligibility Criteria

Age25 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • No systemic disease.
  • No history medication (antibiotics and/or anti inflammatory) in the previous 4 months.
  • Self motivated patients with acceptable oral hygien.

You may not qualify if:

  • Previous orthodontic treatment
  • Aggressive periodontitis
  • Smokers
  • pregnant patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of dental medicine for Girls, AL Azhar University

Cairo, 002, Egypt

Location

Related Publications (1)

  • 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.

    PMID: 31833004BACKGROUND

MeSH Terms

Conditions

Periodontal DiseasesNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesNeoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mohsena A Abdelrazek, Lecturer

    Lecturer of Orthodontic department faculty of Dental medicine for Girls AL-azhar University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: ten patients with periodontally affected teeth subjected to low level laser therapy
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2023

First Posted

February 22, 2023

Study Start

April 1, 2021

Primary Completion

April 1, 2023

Study Completion

May 1, 2023

Last Updated

February 24, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

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

Locations