Periodontal DiseasesNCT05739838
Low-Level Laser Effects on Orthodontic Tooth Movement of Periodontally Compromised Patients.
A study testing Biolase ;Low Level Laser in people with Periodontal Diseases and Cancer Metastatic, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases, Cancer Metastatic, Orthodontic Tooth Movement
- What is being tested?
- Biolase ;Low Level Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2021to May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- No systemic disease.
- No history medication (antibiotics and/or anti inflammatory) in the previous 4 months.
- Self motivated patients with acceptable oral hygien.
Who cannot join
- Previous orthodontic treatment
- Aggressive periodontitis
- Smokers
- pregnant patients
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of dental medicine for Girls, AL Azhar University
Cairo, 002
About this study
Official title: 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.
Read the 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.
- Being tested
- Biolase ;Low Level Laser
- Keywords
- Rate of orthodontic tooth movement, Osteiocalsine
- Medical subject headings
- Periodontal Diseases, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biolase ;Low Level LaserDevice
Also called Biolase
Low Level laser ,940 nm
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of orthodontic tooth movement
Rate of mandibular canine retraction
Measured: 6 months
Secondary outcomes (1)
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2023
- Study start1 Apr 2021
- Primary completionApr 2023 (estimated)
- Study completionMay 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- ten patients with periodontally affected teeth subjected to low level laser therapy
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Faculty of Dental Medicine for Girls
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Mohsena A Abdelrazek, Lecturer, Study director, Lecturer of Orthodontic department faculty of Dental medicine for Girls AL-azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05739838
- Sponsor's protocol ID
- ORTHO-108-6-J
- Status last verified
- Feb 2023
- First submitted
- 13 Feb 2023
- Last updated
- 24 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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
Publications
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.
PubMed 31833004
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Level Laser Effects on Orthodontic Tooth Movement of Periodontally Compromised Patients. Clinical and Biochemical Study
- ClinicalTrials.gov ID
- NCT05739838
- Acronym / sponsor ID
- ORTHO-108-6-J
- Keywords
- Rate of orthodontic tooth movement, Osteiocalsine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Faculty of Dental Medicine for GirlsOther government
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 22 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- ten patients with periodontally affected teeth subjected to low level laser therapy
| Arm | Type | Receives |
|---|---|---|
| Periodontally compromised patients subjected to low level laser therapy | Experimental | Device: Biolase ;Low Level Laserperiodontally 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 | 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. |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- No systemic disease.
- No history medication (antibiotics and/or anti inflammatory) in the previous 4 months.
- Self motivated patients with acceptable oral hygien.
Key exclusion criteria (4 listed)
- Previous orthodontic treatment
- Aggressive periodontitis
- Smokers
- pregnant patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biolase ;Low Level LaserAlso: BiolaseLow Level laser ,940 nm | Device | Periodontally compromised patients subjected to low level laser therapy |
Primary outcome
Rate of orthodontic tooth movement
Time frame: 6 months
Rate of mandibular canine retraction
1 secondary outcome
Osteocalcin level in GCF
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2023.
- Background: PubMed 31833004Ren 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.
- Individual participant dataSharing planned: No. 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohsena A Abdelrazek, Lecturer study director
Lecturer of Orthodontic department faculty of Dental medicine for Girls AL-azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biolase ;Low Level Laser in people with Periodontal Diseases and Cancer Metastatic, run by Faculty of Dental Medicine for Girls at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of orthodontic tooth movement (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05739838, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2023.