MalocclusionNCT04926389
Two Low-level Laser Irradiation Protocols on the Rate of Canine Retraction
A study testing low-level laser therapy applied on days 0, 3,7,14 & every 2 weeks and low-level laser therapy applied every 3 weeks in people with Malocclusion, run by Hams Hamed Abdelrahman at 1 site in Egypt.
Trial summary
Several methods aiming at the acceleration of orthodontic tooth movement have been proposed, including low-level laser therapy (LLLT), which showed promising results. However, the frequency of patient recall has been one of its major drawbacks. Read more about this study
- Who is it for?
- Ages 15 to 25 years
- Conditions the study is for
- Malocclusion
- What is being tested?
- low-level laser therapy applied on days 0, 3,7,14 & every 2 weeks and low-level laser therapy applied every 3 weeks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 15 Jun 2021
- 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 15 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Malocclusion requires at least the extraction of maxillary first premolars, followed by canine retraction into the extraction site.
- Normal shape and structure of the maxillary canines, with no history of root canal treatment.
- Patients with good oral hygiene, and a healthy periodontal condition.
Who cannot join
- Patients who underwent previous orthodontic treatment.
- Patients currently receiving drug therapy that may affect orthodontic tooth movement, e.g. hormonal therapy and corticosteroids.
- Patients with chronic diseases that may affect the rate of tooth movement.
- Pregnancy and lactation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Two Low-level Laser Irradiation Protocols on the Rate of Canine Retraction (a Randomized Controlled Clinical Trial)
Several methods aiming at the acceleration of orthodontic tooth movement have been proposed, including low-level laser therapy (LLLT), which showed promising results. However, the frequency of patient recall has been one of its major drawbacks.
Read the detailed description
A randomized controlled clinical trial will be conducted to address the aim of the study. Sixteen patients will be recruited, requiring the therapeutic extraction of the maxillary 1st premolars, with subsequent canine retraction into the extraction space. The sample will be randomly divided into 2 equal groups, each including 8 subjects.
In Group A, one side of the maxillary arch will randomly receive LLLT on days 0, 3, 7, 14, and every 2 weeks thereafter, while in Group B, one side will also be randomly chosen to receive LLLT every 3 weeks. The contralateral sides of both groups will serve as the controls. The LLLT applied will be Diode laser emitting infrared radiation at wavelength of 980 nm, in a continuous mode.
Canine retraction in both groups will be carried out bilaterally using nickel-titanium closed-coil spring, delivering 150 grams of force, and the rate of tooth movement will be checked every 3 weeks, over a period of 3 months. Other variables will be also examined including, interleukin-1β level in the gingival crevicular fluid, root resorption, and molar anchorage loss.
- Conditions
- Malocclusion
- Being tested
- low-level laser therapy applied on days 0, 3,7,14 & every 2 weeks, low-level laser therapy applied every 3 weeks
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low-level laser therapy applied on days 0, 3,7,14 & every 2 weeksOther
one side of the maxillary arch will randomly receive LLLT on days 0, 3, 7, 14, and every 2 weeks thereafter and the contralateral side will serve as the controls.
low-level laser therapy applied every 3 weeksOther
one side will also be randomly chosen to receive LLLT every 3 weeks and the contralateral side will serve as the controls.
| Study group | Role | What they receive |
|---|---|---|
| low-level laser therapy applied on days 0, 3,7,14 & every 2 weeks | Experimental | Not described Receives: Other: low-level laser therapy applied on days 0, 3,7,14 & every 2 weeks |
| low-level laser therapy applied every 3 weeks | Active comparator | Not described Receives: Other: low-level laser therapy applied every 3 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in rate of canine retraction
Several landmarks will be identified on the dental cast, including the mid-palatal raphe, the most medial points on the third right and left rugae, and the cusp tips of the right and left maxillary canines. Perpendicular lines will be drawn from the medial points of the right and left third rugae, and the cusp tips of the right and left maxillary canines to the mid-palatal raphe. The antero-posterior measurements will be carried out between the canine lines and the third rugae lines bilaterally, to assess the rate of canine retraction.
Measured: at baseline and every 3 weeks for 3 months
change in IL-1β level in the Ginigval Crevicular Fluid
Samples from the GCF will be collected at baseline (before the first canine retraction), in addition to days 7, 14, and 21. GCF samples will be collected from the distal crevices of the canines, in Groups A and B, on both the experimental and control sides. Measurement of IL-1β level in the GCF will be performed using an ELISA kit.
Measured: at baseline, 7th, 17th and 21st day
Secondary outcomes (2)
change canine root resorption:
Root resorption of the maxillary canines will be evaluated and measured on the acquired pre-retraction and post-retraction CBCT scans.
Measured: at baseline and 3 months
Change molar anchorage loss
Perpendicular lines will be drawn from the central fossae of both maxillary right and left first molars to the mid-palatal raphe. Consequently, molar anchorage loss will be calculated by measuring the distance between those lines, and the lines representing the third rugae as previously mentioned.
Measured: at baseline and every 3 weeks for 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2021
- Study start1 Jan 2020
- Primary completion15 Jun 2021 (estimated)
- Study completion15 Jun 2021 (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 MalocclusionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hams Hamed Abdelrahman
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hams Hamed Abdelrahman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04926389
- Sponsor's protocol ID
- Canine retraction 2020
- Status last verified
- Jun 2021
- First submitted
- 3 Jun 2021
- Last updated
- 15 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Eid FY, El-Kenany WA, Mowafy MI, El-Kalza AR. The influence of two photobiomodulation protocols on orthodontically induced inflammatory root resorption (a randomized controlled clinical trial). BMC Oral Health. 2022 Jun 5;22(1):221. doi: 10.1186/s12903-022-02251-w.
PubMed 35659655
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Two Low-level Laser Irradiation Protocols on the Rate of Canine Retraction (a Randomized Controlled Clinical Trial)
- ClinicalTrials.gov ID
- NCT04926389
- Acronym / sponsor ID
- Canine retraction 2020
- Conditions
- Malocclusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Hams Hamed AbdelrahmanUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 15 Jun 2021 (estimated)
- Study completion
- 15 Jun 2021 (estimated)
- First posted
- 15 Jun 2021 (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.
Several methods aiming at the acceleration of orthodontic tooth movement have been proposed, including low-level laser therapy (LLLT), which showed promising results. However, the frequency of patient recall has been one of its major drawbacks.
Detailed description
A randomized controlled clinical trial will be conducted to address the aim of the study. Sixteen patients will be recruited, requiring the therapeutic extraction of the maxillary 1st premolars, with subsequent canine retraction into the extraction space. The sample will be randomly divided into 2 equal groups, each including 8 subjects.
In Group A, one side of the maxillary arch will randomly receive LLLT on days 0, 3, 7, 14, and every 2 weeks thereafter, while in Group B, one side will also be randomly chosen to receive LLLT every 3 weeks. The contralateral sides of both groups will serve as the controls. The LLLT applied will be Diode laser emitting infrared radiation at wavelength of 980 nm, in a continuous mode.
Canine retraction in both groups will be carried out bilaterally using nickel-titanium closed-coil spring, delivering 150 grams of force, and the rate of tooth movement will be checked every 3 weeks, over a period of 3 months. Other variables will be also examined including, interleukin-1β level in the gingival crevicular fluid, root resorption, and molar anchorage loss.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low-level laser therapy applied on days 0, 3,7,14 & every 2 weeks | Experimental | Other: low-level laser therapy applied on days 0, 3,7,14 & every 2 weeks |
| low-level laser therapy applied every 3 weeks | Active comparator | Other: low-level laser therapy applied every 3 weeks |
Who may qualify
- Ages
- 15 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Malocclusion requires at least the extraction of maxillary first premolars, followed by canine retraction into the extraction site.
- Normal shape and structure of the maxillary canines, with no history of root canal treatment.
- Patients with good oral hygiene, and a healthy periodontal condition.
Key exclusion criteria (4 listed)
- Patients who underwent previous orthodontic treatment.
- Patients currently receiving drug therapy that may affect orthodontic tooth movement, e.g. hormonal therapy and corticosteroids.
- Patients with chronic diseases that may affect the rate of tooth movement.
- Pregnancy and lactation
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 |
|---|---|---|
| low-level laser therapy applied on days 0, 3,7,14 & every 2 weeksone side of the maxillary arch will randomly receive LLLT on days 0, 3, 7, 14, and every 2 weeks thereafter and the contralateral side will serve as the controls. | Other | low-level laser therapy applied on days 0, 3,7,14 & every 2 weeks |
| low-level laser therapy applied every 3 weeksone side will also be randomly chosen to receive LLLT every 3 weeks and the contralateral side will serve as the controls. | Other | low-level laser therapy applied every 3 weeks |
Primary outcome
Change in rate of canine retraction
Time frame: at baseline and every 3 weeks for 3 months
Several landmarks will be identified on the dental cast, including the mid-palatal raphe, the most medial points on the third right and left rugae, and the cusp tips of the right and left maxillary canines. Perpendicular lines will be drawn from the medial points of the right and left third rugae, and the cusp tips of the right and left maxillary canines to the mid-palatal raphe. The antero-posterior measurements will be carried out between the canine lines and the third rugae lines bilaterally, to assess the rate of canine retraction.
change in IL-1β level in the Ginigval Crevicular Fluid
Time frame: at baseline, 7th, 17th and 21st day
Samples from the GCF will be collected at baseline (before the first canine retraction), in addition to days 7, 14, and 21. GCF samples will be collected from the distal crevices of the canines, in Groups A and B, on both the experimental and control sides. Measurement of IL-1β level in the GCF will be performed using an ELISA kit.
2 secondary outcomes
change canine root resorption:
Time frame: at baseline and 3 months
Change molar anchorage loss
Time frame: at baseline and every 3 weeks for 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2021.
- Derived from this study: PubMed 35659655Eid FY, El-Kenany WA, Mowafy MI, El-Kalza AR. The influence of two photobiomodulation protocols on orthodontically induced inflammatory root resorption (a randomized controlled clinical trial). BMC Oral Health. 2022 Jun 5;22(1):221. doi: 10.1186/s12903-022-02251-w.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low-level laser therapy applied on days 0, 3,7,14 & every 2 weeks and low-level laser therapy applied every 3 weeks in people with Malocclusion, run by Hams Hamed Abdelrahman 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 15 Jun 2021. 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?
Change in rate of canine retraction (time frame: at baseline and every 3 weeks for 3 months). The study lists 2 primary outcomes in all. 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 NCT04926389, 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 15 Jun 2021.