Micro-osteoperforation Versus Photobiomodulation Therapy for Accelerating Maxillary Canine Retraction

NCT07658235 | Not Yet Recruiting DMC

• 1 other identifier: KU-IRB-2026-5-2
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Malocclusion; Orthodontic Tooth Movement; Maxillary Canine Retraction

Keywords

Micro-osteoperforation; Photobiomodulation therapy; low-level laser therapy; acceleration of tooth movement

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (4)

• Total space-closure duration

  12 months

• Influence of sex on rate of canine retraction

  12 months

• Maxillary canine distal movement

  12 months

• Space closure duration

  12 months

Study Arms (3)

Micro-Osteoperforation (MOP)

EXPERIMENTAL

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)

Photobiomodulation Therapy / LLLT (976 nm)

EXPERIMENTAL

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

Control (Conventional Orthodontic Retraction)

EXPERIMENTAL

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

Interventions

Micro-osteoperforation (MOP) PROCEDURE

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

Micro-Osteoperforation (MOP)

Photobiomodulation Therapy using 976 nm Diode Laser DEVICE

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

Photobiomodulation Therapy / LLLT (976 nm)

Conventional orthodontic canine retraction OTHER

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.

Control (Conventional Orthodontic Retraction)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Age 18 to 40 years at the time of enrollment
• Systemically healthy with no chronic medical conditions affecting bone metabolism or wound healing
• Requiring bilateral maxillary first premolar extraction as part of a comprehensive fixed orthodontic treatment plan
• Class I or mild Class II malocclusion requiring maximum anchorage canine retraction
• Fully erupted maxillary permanent dentition with no missing teeth other than planned extraction teeth
• Good oral hygiene (Plaque Index ≤ 1) and healthy periodontal status (probing depth ≤ 3 mm, no bleeding on probing)
• No previous orthodontic treatment
• Willing to attend all scheduled appointments and comply with study protocol
• Able to provide written informed consent

You may not qualify if:

• Systemic diseases affecting bone metabolism including osteoporosis, osteopenia, diabetes mellitus, thyroid disorders, or autoimmune conditions
• Current use of medications affecting bone remodeling including corticosteroids, bisphosphonates, non-steroidal anti-inflammatory drugs (NSAIDs), or vitamin D supplements
• Current or recent smokers (within the past 6 months)
• Pregnant or breastfeeding women
• History of head and neck radiation therapy
• Periodontal disease or active dental infection at the time of enrollment
• Skeletal Class III malocclusion or severe Class II requiring surgical intervention
• Previous orthodontic treatment or orthognathic surgery
• Craniofacial syndromes or cleft lip and palate
• Photosensitivity disorders or use of photosensitizing medications (relevant to LLLT group)
• Coagulation disorders or anticoagulant therapy (relevant to MOP group)
• Uncooperative patients or those unable to maintain adequate oral hygiene throughout treatment
• Parafunctional habits such as severe bruxism or tongue thrusting'

Sponsors & Collaborators

• Kufa University: lead

Study Sites (1)

University of Kufa College of Dentistry

Najaf, Kufa, 54001, Iraq

Location

Related Publications (5)

• Alhumadi A. Gender-related response to different wavelength low-level laser therapy in orthodontic mandibular canine movement: a split mouth study. 2026. [In press]

  BACKGROUND

• Goncalves A, Monteiro F, Brantuas S, Basset P, Estevez A, Silva FS, Pinho T. Clinical and preclinical evidence on the bioeffects and movement-related implications of photobiomodulation in the orthodontic tooth movement: A systematic review. Orthod Craniofac Res. 2025 Feb;28(1):12-53. doi: 10.1111/ocr.12841. Epub 2024 Aug 2.

  PMID: 39096021 BACKGROUND

• Wazwaz F, Seehra J, Carpenter GH, Papageorgiou SN, Cobourne MT. Duration of canine retraction with fixed appliances: A systematic review and meta-analysis. Am J Orthod Dentofacial Orthop. 2023 Feb;163(2):154-172. doi: 10.1016/j.ajodo.2022.08.009. Epub 2022 Dec 1.

  PMID: 36464569 BACKGROUND

• Hashem BA, El-Hassanein EH, El-Awady AA, Mohamed AA, Hashem MI, Alsarani MM, Hussein FA. Clinical Evaluation of Single Versus Repeated Micro-Osteoperforations During Orthodontic Canine Retraction: A Randomized Clinical Trial. Cureus. 2024 Jan 10;16(1):e52026. doi: 10.7759/cureus.52026. eCollection 2024 Jan.

  PMID: 38344550 BACKGROUND

• Alikhani M, Raptis M, Zoldan B, Sangsuwon C, Lee YB, Alyami B, Corpodian C, Barrera LM, Alansari S, Khoo E, Teixeira C. Effect of micro-osteoperforations on the rate of tooth movement. Am J Orthod Dentofacial Orthop. 2013 Nov;144(5):639-48. doi: 10.1016/j.ajodo.2013.06.017.

  PMID: 24182579 BACKGROUND

MeSH Terms

Conditions

Malocclusion

Interventions

Lasers, Semiconductor

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Central Study Contacts

Almustafa wisam Ahumadi, master

CONTACT

009647821630001; almusafaw.alhumadi@uokufa.edu.iq

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The participant cannot be blinded - they know whether they received drilling (MOP) or laser (LLLT) The operator cannot be blinded - they perform the procedure The outcomes assessor (who measures canine movement on study models) can and must be blinded - this is your main protection against measurement bias
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: A three-arm parallel-group randomized controlled clinical trial in which participants are randomly assigned in a 1:1:1 ratio to one of three groups: (A) micro-osteoperforation (MOP), (B) photobiomodulation therapy using a 976 nm diode laser (PBMT/LLLT), or (C) conventional orthodontic canine retraction without adjunctive intervention (control).

Study Record Dates

• First Submitted: June 6, 2026
• First Posted: June 18, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): March 28, 2027
• Study Completion (Estimated): May 28, 2027
• Last Updated: June 18, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)