An interventional study of Micro-osteoperforation (MOP) and Photobiomodulation Therapy using 976 nm Diode Laser in Malocclusion, Orthodontic Tooth Movement and Maxillary Canine Retraction, sponsored by Kufa University. Not yet recruiting at 1 site in Iraq. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-18.
Sponsored by Kufa University · Not applicable, Interventional, and Treatment
Orthodontic treatment often requires moving the upper canine teeth (the pointed teeth) into the spaces left after removing premolar teeth. This process is usually slow and can take many months, making the total treatment time longer.This study will compare two techniques that may speed up this tooth movement:
Micro-osteoperforation (MOP): A minimally invasive procedure in which a small device is used to create tiny holes in the jawbone near the canine tooth under local anesthesia. These micro-perforations stimulate the bone to remodel faster, which allows the tooth to move more quickly.
Photobiomodulation therapy (PBMT) / Low-Level Laser Therapy (LLLT): A painless, non-invasive technique that uses a low-power laser light applied to the gum tissue near the canine tooth. The laser energy stimulates cells in the bone and supporting tissues to accelerate tooth movement without any cutting or drilling.
This trial will randomly assign eligible patients into one of three groups: MOP, LLLT, or a control group receiving standard orthodontic treatment only. Each group will contain 25 participants (75 total). The main goal is to measure and compare how fast the upper canine tooth moves in each group over the first month and until the space is fully closed. The study will also measure the effect of age and sex on the results. The findings will help orthodontists choose the best, fastest, and most comfortable method for each patient to shorten overall treatment time
Background:
Maxillary canine retraction following first premolar extraction represents the most time-consuming phase of fixed orthodontic therapy, often requiring five to eight months under conventional mechanics. Prolonged treatment duration is associated with increased risks of root resorption, periodontal deterioration, white spot lesions, and reduced patient compliance. Several adjunctive techniques have been proposed to accelerate orthodontic tooth movement (OTM), of which micro-osteoperforation (MOP) and photobiomodulation therapy (PBMT) have demonstrated the most consistent clinical evidence. However, no randomized controlled trial has directly compared these two modalities against each other and against a conventional control under standardized conditions.
Rationale for study design:
A three-arm parallel-group randomized controlled clinical trial (RCT) design was selected in preference to a split-mouth design. Although split-mouth designs offer statistical efficiency, the comparison of MOP and PBMT in a split-mouth model is methodologically inappropriate due to: (1) the risk of contralateral biological cross-contamination from the Regional Acceleratory Phenomenon (RAP) induced by MOP; (2) the potential for sub-therapeutic photon scatter from LLLT irradiation reaching contralateral tissues; and (3) the ethical concern of exposing individual patients to two mechanistically distinct and invasive/non-invasive interventions simultaneously. A parallel-arm design with a true control group eliminates these confounders and allows independent evaluation of each intervention's efficacy.
Objectives:
Primary: To compare the rate of maxillary canine retraction (mm/month) at one month and among patients receiving MOP, PBMT/LLLT, or conventional orthodontic treatment alone.
Secondary: To compare total space-closure duration (months)
Participants:
Seventy-five systemically healthy adults (aged 18-40 years) requiring bilateral maxillary first premolar extraction and fixed orthodontic therapy will be recruited from the Department of Orthodontics. Participants will be equally randomized to one of three groups (n = 25 each) using a computer-generated randomization sequence stratified by age (≤25 / >25 years) and sex.
Interventions:
Group A - MOP: Micro-osteoperforations will be performed under local anesthesia using a PROPEL device (or equivalent). Three perforations of 3 mm depth will be placed mesial and three distal to each maxillary canine (six total per side) at baseline and repeated every four weeks until space closure.
Group B - PBMT/LLLT: A 976 nm diode laser (Woodpecker LX16 Plus or equivalent) will be applied at 8 J/cm², 0.13 W, continuous-wave mode at six mucosal sites per canine (three buccal, three palatal) on days 0, 3, 7, and 14, then every two weeks until space closure.
Group C - Control: Standard orthodontic canine retraction using identical elastomeric power chain force (150 g) without any adjunctive intervention.
All groups will use standardized elastomeric power chain force of 150 g, recalibrated at each monthly visit. Teeth will be retracted on 0.019 × 0.025-inch stainless steel archwires with maximum anchorage (skeletal anchorage via miniscrews or equivalent).
Outcome measurement:
The primary outcome (canine movement in mm) will be measured by a single blinded examiner using a digital Vernier caliper (±0.01 mm precision) on dental study models obtained at baseline, one month, and at space-closure completion.
Sample size:
Based on a weighted mean difference of 0.40 mm in canine movement between MOP/LLLT and control groups, a pooled standard deviation of 0.50 mm, α = 0.05, and 80% power for a one-way ANOVA comparison, 21 participants per group are required. Rounding up to 25 per group accommodates a 20% dropout rate, giving a total sample of 75 participants.
Statistical analysis:
One-way ANOVA with post-hoc Tukey's test for continuous normally distributed outcomes; Kruskal-Wallis test for non-normal outcomes; repeated-measures ANOVA for time-dependent data; Pearson or Spearman correlation for age and sex analyses. Significance set at p ≤ 0.05. Intention-to-treat analysis will be the primary analysis, with per-protocol analysis as a sensitivity check.
Ethics and registration:
Ethical approval obtained from the Institutional Review Board before recruitment. Written informed consent will be obtained from all participants. The trial is prospectively registered on ClinicalTrials.gov prior to enrollment of the first participant, in compliance with ICMJE guidelines and publication requirements.
323 studies on the registry are indexed under Malocclusion; 85 are open to participants now.
This study's planned enrollment of 75 is above the median of 37 across 242 interventional studies indexed under Malocclusion.
Browse Malocclusion studies →Kufa University is the lead sponsor of 14 studies on the registry; 3 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive bilateral maxillary canine retraction using a standardized elastomeric power chain force of 150 g on 0.019×0.025-inch stainless steel archwires. Micro-osteoperforations are performed under local anesthesia using a PROPEL device (or equivalent). Six perforations of 3 mm depth are placed per canine (3 mesial, 3 distal) at baseline and repeated every 4 weeks until complete space closure.
Procedure: Micro-osteoperforation (MOP)
Participants receive bilateral maxillary canine retraction using identical mechanics to the MOP group. A 976 nm diode laser (Woodpecker LX16 Plus or equivalent) is applied at 8 J/cm², 0.13 W, continuous-wave mode at 6 mucosal sites per canine (3 buccal, 3 palatal) on days 0, 3, 7, and 14, then every 2 weeks until complete space closure. No anesthesia is required.
Device: Photobiomodulation Therapy using 976 nm Diode Laser
Participants receive standard bilateral maxillary canine retraction using a standardized elastomeric power chain force of 150 g on 0.019×0.025-inch stainless steel archwires. No adjunctive intervention is applied. This group serves as the comparator to quantify the absolute acceleration produced by MOP and LLLT.
Other: Conventional orthodontic canine retraction
Six micro-osteoperforations of 3 mm depth are created under local anesthesia (2% lidocaine with 1:100,000 epinephrine) using a PROPEL device or equivalent, with 3 perforations placed mesial and 3 distal to each maxillary canine on the buccal attached gingiva. The procedure is performed at baseline and repeated every 4 weeks until complete extraction space closure. All participants also receive standardized canine retraction using 150 g elastomeric power chain force on 0.019×0.025-inch stainless steel archwires
A 976 nm diode laser (Woodpecker LX16 Plus or equivalent) is applied in continuous-wave mode at a power of 0.13 W and energy density of 8 J/cm² per point. Irradiation is delivered at 6 mucosal sites per canine (3 buccal, 3 palatal) with the laser tip held perpendicular to the tissue surface at each point. Sessions are performed on days 0, 3, 7, and 14 after each activation, then every 2 weeks until complete extraction space closure. No anesthesia is required. All participants also receive standardized canine retraction using 150 g elastomeric power chain force on 0.019×0.025-inch stainless steel archwires
Standard bilateral maxillary canine retraction is performed using a standardized elastomeric power chain force of 150 g on 0.019×0.025-inch stainless steel archwires. Force is recalibrated at each monthly appointment. No adjunctive biological or physical intervention is applied. This arm serves as the active comparator to quantify the absolute acceleration produced by MOP and LLLT relative to conventional mechanics alone.
Rate of maxillary canine retraction
The amount of maxillary canine distal movement (mm) measured from the CUSP TIP of the canine to the distal contact point of the lateral incisor using a digital Vernier caliper with 0.01 mm precision. Measurements are performed by a single blinded examiner at baseline and one month after initiation of canine retraction.
Time frame: 12 months
Total space-closure duration
ription: The total time in months from the start of canine retraction until complete closure of the extraction space, confirmed clinically by the blinded examiner.
Time frame: 12 months
Influence of sex on rate of canine retraction
Independent-samples t-test comparison between male and female participants for two outcome measures: (1) the amount of canine distal movement (mm) at one month, and (2) the total space-closure duration (months). This analysis determines whether biological sex significantly modifies the response to micro-osteoperforation or photobiomodulation therapy during orthodontic canine retraction.
Time frame: 12 months
Maxillary canine distal movement
Distance of canine movement measured in millimeters from study models/digital scans.
Time frame: 12 months
Space closure duration
Time required to achieve complete extraction space closure measured in months.
Time frame: 12 months
Plan to share: No — Individual participant data (IPD) will not be shared publicly due to institutional data privacy regulations and patient confidentiality requirements in accordance with the ethical approval conditions granted by the Institutional Review Board. Aggregate summary data and statistical results will be made available through peer-reviewed publication of the study findings. Researchers wishing to access de-identified data for collaborative purposes may submit a formal written request to the corresponding author, subject to approval by the institutional ethics committee and execution of a data sharing agreement.
Start is estimated for Jul 2026; primary completion for Mar 2027, 8 months later.
Of 153 non-industry interventional studies with no phase under Malocclusion, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 30. This study's planned 8 months is below that.
Counting every sponsor, half of 163 studies reached it within 19 months; a quarter within 10 and three quarters within 32.
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