Orthodontic Appliance ComplicationNCT05120102
Influence of Low Level Laser Therapy on the Rate of Orthodontic Tooth Movement and Associated Pain
A study testing Diode laser in people with Orthodontic Appliance Complication, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial summary
This is a single blind randomized controlled trial with split mouth design including 45 patients with extractions of maxillary 1st bicuspids. First leveling and alignment will take place till 17 × 25 Stainless Steel wire pass passively through all the brackets. Read more about this study
- Who is it for?
- Ages 15 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Appliance Complication
- What is being tested?
- Diode laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2019to 30 Aug 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 15 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- age between 15-30 years
- Patients having symmetric extraction of maxillary 1st bicuspids
- All dentitions till 2nd molars should be erupted in the arch
Who cannot join
- Patients with Long term medication or with a history of radiotherapy or chemotherapy.
- Patients with Parafunctional habit.
- Patients with severe tooth displacement (ectopic canine), patients with missing teeth and impacted teeth (except third molars).
- Tooth morphological anomalies especially in the maxillary canines determined clinically or on OrthoPantomoGram/periapical X-rays.
- Patients with any systemic or metabolic disorder or bone pathology.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Dow university of health sciences
Karachi, Sindh
Hafiza M Khurshid, MDS, 3432459580, mammarry21@gmail.com
About this study
This is a single blind randomized controlled trial with split mouth design including 45 patients with extractions of maxillary 1st bicuspids. First leveling and alignment will take place till 17 × 25 Stainless Steel wire pass passively through all the brackets. Canine retraction will be done through elastomeric ligatures maintaining force of 150gm on both sides. One of side of maxillary arch will be irradiated by diode laser (aluminum-gallium-arsenide) of 980nm on cervical, middle, and apical third on buccal and palatal surface of cuspid and the other side will act as placebo. Laser irradiation will be done at baseline and then for 3 more consecutive visits. Measurements will be recorded from maxillary canine hook to maxillary 1st molar hook at 3 weeks interval till complete canine retraction will be achieved. Patients will be given a questionnaires supported numeric scale to record their pain score for a week.
Read the detailed description
First ethical approval for the study is going to be taken from the scientific committee and then Institutional Review Board of Dow University of Health Sciences. After getting informed consent from the chosen study participants, banding and bonding of the maxillary arch are going to be done through conventional fixed appliance Edgewise brackets. Initial leveling and alignment are going to be achieved by using nickel titanium and round stainless-steel wires until 0.017x0.025-inch stainless-steel wire passes passively through all fixed appliance. Anchorage is going to be implemented by skeletal anchorage through mini implants and molar stops on 0.017×0.025-inch stainless-steel wire just mesial to upper 1st molar band slot. As this study features a split mouth design so, every study subject will receive Gallium-Aluminum-Arsenic diode laser with a wavelength of 980nm ± 10nm on one maxillary canine and a placebo effect on the other maxillary canine. The side receiving laser irradiation is going to be alternated with every consecutive patient. To prevent from chauffeuring effect, a plastic shield will be used. The patient will be given questionnaire based scale to record pain score for a week.
Distalization of the canines is going to be accomplished by elastomeric chain (Medium span, Ortho Organizer) which can begin instantly after extraction of first premolars. There is no distinction between retraction rate of canines using either elastomeric chain or Nickel Titanium springs.
All study measurements will be taken using 0.01mm with digital Vernier caliper considering hook of maxillary cuspid teeth and hook of maxillary 1st molar teeth as reference points. Measurements will be recorded thrice in a single visit and mean is taken to avoid bias. Readings will be recorded after every three-weeks interval until one of the canines is completely retracted. Arch length will be measured on the cast as inter molar width. Patients will be given a questionnaire supported numeric scale to record their pain score for a week.
- Conditions
- Orthodontic Appliance Complication
- Being tested
- Diode laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diode laserDevice
K2 diode laser of 980nm wavelength
| Study group | Role | What they receive |
|---|---|---|
| Experimental side of the arch | Experimental | The right or left side of the patients maxillary arch selected by randomization Receives: Device: Diode laser |
| Placebo side of the arch | No intervention | The right or left side of the patients maxillary arch selected by randomization |
What is being measured
The primary outcome is the main question the study is designed to answer.
orthodontic tooth movement
tooth movement measured in millimeters
Measured: 6months
Secondary outcomes (1)
orthodontic pain
pain score through visual analogue scale having a score zero means no pain to score 5 means worst
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start1 Aug 2019
- Primary completion1 Dec 2022 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Orthodontic Appliance ComplicationStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Imtiaz Dr Ahmed, FCPS, Study director, Supervisor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120102
- Sponsor's protocol ID
- DuhsDikiohs
- Status last verified
- Nov 2021
- First submitted
- 14 Oct 2021
- Last updated
- 22 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Visit duhs web page
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Low Level Laser Therapy on the Rate of Orthodontic Tooth Movement and Associated Pain
- ClinicalTrials.gov ID
- NCT05120102
- Acronym / sponsor ID
- DuhsDikiohs
- Conditions
- Orthodontic Appliance Complication
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Dec 2022 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 15 Nov 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.
This is a single blind randomized controlled trial with split mouth design including 45 patients with extractions of maxillary 1st bicuspids. First leveling and alignment will take place till 17 × 25 Stainless Steel wire pass passively through all the brackets. Canine retraction will be done through elastomeric ligatures maintaining force of 150gm on both sides. One of side of maxillary arch will be irradiated by diode laser (aluminum-gallium-arsenide) of 980nm on cervical, middle, and apical third on buccal and palatal surface of cuspid and the other side will act as placebo. Laser irradiation will be done at baseline and then for 3 more consecutive visits. Measurements will be recorded from maxillary canine hook to maxillary 1st molar hook at 3 weeks interval till complete canine retraction will be achieved. Patients will be given a questionnaires supported numeric scale to record their pain score for a week.
Detailed description
First ethical approval for the study is going to be taken from the scientific committee and then Institutional Review Board of Dow University of Health Sciences. After getting informed consent from the chosen study participants, banding and bonding of the maxillary arch are going to be done through conventional fixed appliance Edgewise brackets. Initial leveling and alignment are going to be achieved by using nickel titanium and round stainless-steel wires until 0.017x0.025-inch stainless-steel wire passes passively through all fixed appliance. Anchorage is going to be implemented by skeletal anchorage through mini implants and molar stops on 0.017×0.025-inch stainless-steel wire just mesial to upper 1st molar band slot. As this study features a split mouth design so, every study subject will receive Gallium-Aluminum-Arsenic diode laser with a wavelength of 980nm ± 10nm on one maxillary canine and a placebo effect on the other maxillary canine. The side receiving laser irradiation is going to be alternated with every consecutive patient. To prevent from chauffeuring effect, a plastic shield will be used. The patient will be given questionnaire based scale to record pain score for a week.
Distalization of the canines is going to be accomplished by elastomeric chain (Medium span, Ortho Organizer) which can begin instantly after extraction of first premolars. There is no distinction between retraction rate of canines using either elastomeric chain or Nickel Titanium springs.
All study measurements will be taken using 0.01mm with digital Vernier caliper considering hook of maxillary cuspid teeth and hook of maxillary 1st molar teeth as reference points. Measurements will be recorded thrice in a single visit and mean is taken to avoid bias. Readings will be recorded after every three-weeks interval until one of the canines is completely retracted. Arch length will be measured on the cast as inter molar width. Patients will be given a questionnaire supported numeric scale to record their pain score for a week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental side of the arch | Experimental | Device: Diode laserThe right or left side of the patients maxillary arch selected by randomization |
| Placebo side of the arch | No intervention | –The right or left side of the patients maxillary arch selected by randomization |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- age between 15-30 years
- Patients having symmetric extraction of maxillary 1st bicuspids
- All dentitions till 2nd molars should be erupted in the arch
Key exclusion criteria (5 listed)
- Patients with Long term medication or with a history of radiotherapy or chemotherapy.
- Patients with Parafunctional habit.
- Patients with severe tooth displacement (ectopic canine), patients with missing teeth and impacted teeth (except third molars).
- Tooth morphological anomalies especially in the maxillary canines determined clinically or on OrthoPantomoGram/periapical X-rays.
- Patients with any systemic or metabolic disorder or bone pathology.
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 |
|---|---|---|
| Diode laserK2 diode laser of 980nm wavelength | Device | Experimental side of the arch |
Primary outcome
orthodontic tooth movement
Time frame: 6months
tooth movement measured in millimeters
1 secondary outcome
orthodontic pain
Time frame: 6months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2021.
- Individual participant dataSharing planned: Yes. Visit duhs web page
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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.
Imtiaz Dr Ahmed, FCPS study director
Supervisor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diode laser in people with Orthodontic Appliance Complication, run by Dow University of Health Sciences at 1 site in Pakistan.
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 5 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 22 Nov 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 Pakistan. 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?
Contact Hafiza M Khurshid, MDS (03432459580, mammarry21@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
orthodontic tooth movement (time frame: 6months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Nov 2021.