Orthodontic Tooth MovementNCT07626580
Comparison of Rate of Tooth Movement Between MOPs vs MOPs & LLLT Combined
A study testing Micro-osteoperforation and Low Level Laser Therapy and Micro-osteoperforations Combined in people with Orthodontic Tooth Movement and Low Level Laser Therapy, run by Riphah International University at 1 site in Pakistan.
Trial summary
Orthodontic treatment is often prolonged, requiring years to achieve desirable outcomes. The prolonged duration of treatment increases the risk of complications such as root resorption, periodontal damage, and patient non-compliance. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Orthodontic Tooth Movement, Low Level Laser Therapy, Canine Retraction
- What is being tested?
- Micro-osteoperforation and Low Level Laser Therapy and Micro-osteoperforations Combined
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 sitePakistan
- Study dates
- Jun 2026to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Patients aged 12-30 years requiring fixed orthodontic treatment.
- Patients with Class I or mild-to-moderate Class II malocclusion requiring canine retraction.
- No history of previous orthodontic treatment.
- Patients with indications for the extraction of the first premolars on both sides of the maxilla.
Who cannot join
- • Patients with systemic conditions affecting bone metabolism (e.g., osteoporosis, diabetes).
- Smokers and individuals with poor oral hygiene.
- Pregnant or lactating women.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Islamic International Dental Hospital
Islamabad, Punjab Province
Ulfat Bashir, FCPS, MPH, +923335118561, ulfat.bashir@riphah.edu.pk
Nauman Arshad, MDS
About this study
Official title: Comparison of Rate of Tooth Movement Between Micro-osteoperforations Versus Micro-osteoperforations and Low Level Laser Therapy Combined
Orthodontic treatment is often prolonged, requiring years to achieve desirable outcomes. The prolonged duration of treatment increases the risk of complications such as root resorption, periodontal damage, and patient non-compliance.
To address these concerns, various methods have been explored to accelerate orthodontic tooth movement, including pharmacological agents, mechanical vibration, corticotomies, and minimally invasive techniques like Micro-Osteoperforations (MOPs) and Low-Level Laser Therapy (LLLT). Micro-Osteoperforations (MOPs) have gained popularity as a minimally invasive technique that enhances bone remodeling by inducing a localized inflammatory response, thereby accelerating tooth movement.
Read more
Studies have shown that MOPs can effectively stimulate the expression of cytokines, increasing osteoclastic activity and facilitating rapid orthodontic tooth movement. However, the extent of its effectiveness varies among individuals, necessitating additional interventions to maximize efficiency. Low-Level Laser Therapy (LLLT), also known as photobiomodulation, is another promising adjunct in orthodontics. LLLT has been reported to enhance cellular activity, promote osteoblastic and osteoclastic function, and improve tissue healing, leading to accelerated tooth movement. Several studies suggest that LLLT alone can expedite orthodontic treatment, but its combination with MOPs has not been extensively explored.
This study aims to compare the rate of orthodontic tooth movement between MOPs alone and MOPs combined with LLLT. By evaluating these two techniques, this research seeks to determine whether LLLT enhances the effectiveness of MOPs in accelerating tooth movement. The findings of this study could provide valuable insights into optimizing orthodontic treatment duration while minimizing potential risks and discomfort for patients.
Read the detailed description
INTRODUCTION
Orthodontic treatment is often prolonged, requiring years to achieve desirable outcomes. The prolonged duration of treatment increases the risk of complications such as root resorption, periodontal damage, and patient non-compliance.
To address these concerns, various methods have been explored to accelerate orthodontic tooth movement, including pharmacological agents, mechanical vibration, corticotomies, and minimally invasive techniques like Micro-Osteoperforations (MOPs) and Low-Level Laser Therapy (LLLT). Micro-Osteoperforations (MOPs) have gained popularity as a minimally invasive technique that enhances bone remodeling by inducing a localized inflammatory response, thereby accelerating tooth movement.
Studies have shown that MOPs can effectively stimulate the expression of cytokines, increasing osteoclastic activity and facilitating rapid orthodontic tooth movement. However, the extent of its effectiveness varies among individuals, necessitating additional interventions to maximize efficiency. Low-Level Laser Therapy (LLLT), also known as photobiomodulation, is another promising adjunct in orthodontics. LLLT has been reported to enhance cellular activity, promote osteoblastic and osteoclastic function, and improve tissue healing, leading to accelerated tooth movement. Several studies suggest that LLLT alone can expedite orthodontic treatment, but its combination with MOPs has not been extensively explored.
This study aims to compare the rate of orthodontic tooth movement between MOPs alone and MOPs combined with LLLT. By evaluating these two techniques, this research seeks to determine whether LLLT enhances the effectiveness of MOPs in accelerating tooth movement. The findings of this study could provide valuable insights into optimizing orthodontic treatment duration while minimizing potential risks and discomfort for patients.
OBJECTIVE: To compare the rate of orthodontic tooth movement between MOPs alone and MOPs combined with LLLT.
HYPOTHESIS:
Null Hypothesis (H₀):
There is no significant difference in the rate of tooth movement between patients who undergo Micro-Osteoperforations (MOPs) alone and those who undergo Micro-Osteoperforations combined with Low-Level Laser Therapy (LLLT).
Alternative Hypothesis (H₁):
The rate of tooth movement is significantly higher in patients who undergo Micro-Osteoperforations combined with Low-Level Laser Therapy (LLLT) compared to those who undergo Micro-Osteoperforations (MOPs) alone.
OPERATIONAL DEFINITIONS:
- Rate of Tooth Movement: The rate of tooth movement refers to the measurable change in the position of a tooth over a specific period of time, expressed in millimeters per month. This measurement is typically taken at regular intervals using clinical assessments, such as digital calipers or radiographs (e.g., periapical radiographs or CBCT scans) to accurately track the movement of the tooth. The rate of tooth movement is calculated by dividing the total distance moved by the number of months it takes to achieve that movement.
- Visual Analog Scale (VAS): The Visual Analog Scale (VAS) is a simple and widely used scale that provides a continuous measure of intensity along a straight line, typically 10 cm long. One end of the line represents no pain (usually labeled as "0"), and the other end represents the worst possible pain (labeled as "10").
- Root resorption: It is measured as the loss of root structure, quantified by the degree of reduction in root length or volume. It will be assessed using Cone Beam Computed Tomography (CBCT) or periapical radiographs, where the degree of resorption is categorized into different levels based on observable changes in the root morphology:
- None: No evidence of root resorption.
- Mild: Minimal loss of root structure, less than 10% of the root length or volume affected.
- Moderate: Moderate loss of root structure, between 10-30% of the root length or volume affected.
- Severe: Significant loss of root structure, greater than 30% of the root length or volume affected.
MATERIAL \& METHOD:
Study Design: Split mouth Randomized controlled trial (One side of each patient's mouth will be designated as Group A, while the other side will be assigned to Group B)
SELECTION CRITERIA:
Inclusion Criteria:
- Patients aged 12-30 years requiring fixed orthodontic treatment.
- Patients with Class I or mild-to-moderate Class II malocclusion requiring canine retraction.
- No history of previous orthodontic treatment.
- Patients with indications for the extraction of the first premolars on both sides of the maxilla.
Exclusion criteria:
- Patients with systemic conditions affecting bone metabolism (e.g., osteoporosis, diabetes).
- Smokers and individuals with poor oral hygiene.
- Pregnant or lactating women.
Sample Size:
It will be a randomized controlled trial. Each patient would receive MOP on one side and MOP + Laser on the other side, randomly assigned.
33 subjects, for a total sample size of 66. n = 2(1.96 + 0.84)2 (0.48)2 / (0.53)2 = 32.4
Materials:
Diode Laser: Woodpecker LX16 Plus Diode Laser (976± 20nm) Micro-osteoperforations: GNI Mini Screws dimensions 1.8mm to 8mm
Methodology:
After the approval of ethical committee of Riphah International University, Islamabad, Pakistan, patients fulfill the selection criteria will be enrolled. A written informed consent will be taken from patients. A total of 66 participants will be enrolled in the study. One side of each patient's mouth will be designated as Group A, while the other side will be assigned to Group B using the block randomization method. Group A will undergo micro-osteoperforations at designated sites along the extraction space, while Group B will receive micro-osteoperforations in combination with Low-Level Laser Therapy at specified intervals. The intervention protocol consists of two approaches: Micro-Osteoperforations (MOPs) alone and Micro-Osteoperforations combined with Low-Level Laser Therapy (LLLT). MOPs will be performed using a sterile surgical instrument under local anesthesia, ensuring patient comfort during the procedure. Small perforations will be created in the alveolar bone adjacent to the tooth undergoing orthodontic movement. These perforations are intended to stimulate localized bone remodeling by enhancing osteoclastic activity, thereby facilitating a faster rate of tooth movement. For patients in the LLLT group, a diode laser with a wavelength of 600-1000 nm will be applied at predetermined power settings and specific time intervals following the MOPs procedure. The application of LLLT is expected to enhance cellular activity, promote osteoblastic and osteoclastic function, and accelerate tooth movement while potentially reducing post-procedural discomfort and inflammation. The primary outcome measure of this study will be the rate of orthodontic tooth movement, quantified in millimeters per month to determine the efficacy of each intervention. Secondary outcome measures will include pain levels, assessed using the Visual Analog Scale (VAS) to evaluate patient discomfort; root resorption, measured through Cone Beam Computed Tomography (CBCT) or periapical radiographs to assess any structural changes in dental roots; and patient compliance and satisfaction, which will be recorded through self-reported feedback and adherence to treatment protocols. A predesign structured questionere will be used to collect data.
DATA ANALYSIS PROCEDURE: Gathered data will be entered and analyzed by the computer software Statistical Package for Social Sciences (SPSS) Version 25. The results for all Quantitative variables: age, Rate of tooth movement, Pain levels and Root resorption will be expressed as mean ± SD. Frequency and percentages will be calculated for categorical variables such as gender, different levels of pain (e.g., no pain, mild pain, moderate pain, severe pain), Root resorption e.g., none, mild, moderate, severe and Patient compliance and satisfaction. Effect modifier such as age, gender, will be addressed through post stratification. Post stratification chi square test or Fisher's exact test will be applied in which p value of < 0.05 will be significant.
- Being tested
- Micro-osteoperforation, Low Level Laser Therapy and Micro-osteoperforations Combined
- Keywords
- Low Level Laser Therapy, LLLT, Micro-Osteoperforations, Canine Retraction, Maxillary Scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Micro-osteoperforationOther
MOPs will be performed using a sterile surgical instrument under local anesthesia, ensuring patient comfort during the procedure. Small perforations will be created in the alveolar bone adjacent to the tooth undergoing orthodontic movement along the long axis of the tooth with rule of 3, 3mm difference between three sites along the distal root of Canine. The intervention was repeated after 3 weeks interval for 9 weeks. GNI Mini Screws 1.8 x 8 mm
Low Level Laser Therapy and Micro-osteoperforations CombinedDevice
Woodpecker LX16 Plus Diode Laser (976± 20nm) will be applied at 5W and Frequency of 10000 Hz for 8 seconds producing a total of 8J Energy.
MOPs will be performed using a sterile surgical instrument under local anesthesia, ensuring patient comfort during the procedure. Small perforations will be created in the alveolar bone adjacent to the tooth undergoing orthodontic movement along the long axis of the tooth with rule of 3, 3mm difference between three sites along the distal root of Canine. The intervention was repeated after 3 weeks interval for 9 weeks. GNI Mini Screws 1.8 x 8 mm
| Study group | Role | What they receive |
|---|---|---|
| Right side LLLT + MOP, Left side MOP only | Experimental | Group A will undergo micro-osteoperforations on Left side and Microosteoperforations with Low Level Laser Therapy combined on Right side of the Maxillary Arch Receives: Other: Micro-osteoperforation; Device: Low Level Laser Therapy and Micro-osteoperforations Combined |
| Right side MOP only, Left side LLLT + MOP | Experimental | Group B will undergo micro-osteoperforations on Right side and Microosteoperforations with Low Level Laser Therapy combined on Leftside of the Maxillary Arch Receives: Other: Micro-osteoperforation; Device: Low Level Laser Therapy and Micro-osteoperforations Combined |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Tooth Movement
To compare the rate of orthodontic tooth movement while retraction of Maxillary Canine in extracted first premolar sight between MOPs alone and MOPs combined with LLLT. The mesurements were done on Intraoral scan of Maxilla, before the experiment and after 9 weeks, the MOPs and LLLT were repeated after every 3 weeks.
Measured: 3 weeks
Secondary outcomes (2)
Root Resorption
: It is measured as the loss of root structure, quantified by the degree of reduction in root length or volume. It will be assessed using Cone Beam Computed Tomography (CBCT) or periapical radiographs, where the degree of resorption is categorized into different levels based on observable changes in the root morphology:
- None: No evidence of root resorption.
- Mild: Minimal loss of root structure, less than 10% of the root length or volume affected.
- Moderate: Moderate loss of root structure, between 10-30% of the root length or volume affected.
- Severe: Significant loss of root structure, greater than 30% of the root length or volume affected.
Measured: 3 weeks
Pain in each visit
To measure pain in each visit, Visual Analog Scale (VAS) is used.It is a simple and widely used scale that provides a continuous measure of intensity along a straight line, typically 10 cm long. One end of the line represents no pain (usually labeled as "0"), and the other end represents the worst possible pain (labeled as "10").
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study startJun 2026 (estimated)
- Primary completionSep 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Orthodontic Tooth MovementStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- 33 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ulfat Bashir, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07626580
- Sponsor's protocol ID
- IIDC/IRC/2025 Nauman Arshad
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Moradinejad M, Chaharmahali R, Shamohammadi M, Mir M, Rakhshan V. Low-level laser therapy, piezocision, or their combination vs. conventional treatment for orthodontic tooth movement : A hierarchical 6-arm split-mouth randomized clinical trial. J Orofac Orthop. 2024 Mar;85(2):110-122. doi: 10.1007/s00056-022-00427-1. Epub 2022 Sep 21.
PubMed 36129485Huang CY, Le HHT, Tsai HC, Tang CH, Yu JH. The effect of low-level laser therapy on osteoclast differentiation: Clinical implications for tooth movement and bone density. J Dent Sci. 2024 Jul;19(3):1452-1460. doi: 10.1016/j.jds.2024.03.023. Epub 2024 Mar 30.
PubMed 39035342Alzahrani AM, Aljibrin FJ, Alqahtani AM, Saklou R, Alhassan IA, Alamer AH, Al Ameer MH, Hatami MS, Dahhas FY. Photobiomodulation in Orthodontics: Mechanisms and Clinical Efficacy for Faster Tooth Movement. Cureus. 2024 Apr 26;16(4):e59061. doi: 10.7759/cureus.59061. eCollection 2024 Apr.
PubMed 38800347Ciobotaru CD, Festila D, Dinte E, Muntean A, Bosca BA, Ionel A, Ilea A. Enhancement of Orthodontic Tooth Movement by Local Administration of Biofunctional Molecules: A Comprehensive Systematic Review. Pharmaceutics. 2024 Jul 25;16(8):984. doi: 10.3390/pharmaceutics16080984.
PubMed 39204329Narayan H. Gandedkar, Oyku Dalci, M. Ali Darendeliler, Accelerated orthodontics (AO): The past, present and the future, Seminars in Orthodontics, Volume 30, Issue 2, 2024, Pages 172-182, ISSN 1073-8746, https://doi.org/10.1053/j.sodo.2024.01.012.
Dipalma, Gianna, Assunta Patano, Irene Ferrara, Fabio Viapiano, Anna Netti, Sabino Ceci, Daniela Azzollini, Anna Maria Ciocia, Giuseppina Malcangi, Alessio Danilo Inchingolo, and et al. 2023. "Acceleration Techniques for Teeth Movements in Extractive Orthodontic Therapy" Applied Sciences 13, no. 17: 9759. https://doi.org/10.3390/app13179759
Ramseier CA. Diagnostic measures for monitoring and follow-up in periodontology and implant dentistry. Periodontol 2000. 2024 Jun;95(1):129-155. doi: 10.1111/prd.12588. Epub 2024 Jul 1.
PubMed 38951873Pattanaik S, Veeraraghavan VP, Dasari AK, Patil SR, Alzahrani SG, Fareed M. Orthodontic treatment in adults: Challenges, outcomes, and factors affecting compliance and satisfaction. J Orthod Sci. 2024 May 8;13:14. doi: 10.4103/jos.jos_186_23. eCollection 2024.
PubMed 38784082
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Rate of Tooth Movement Between Micro-osteoperforations Versus Micro-osteoperforations and Low Level Laser Therapy Combined
- ClinicalTrials.gov ID
- NCT07626580
- Acronym / sponsor ID
- IIDC/IRC/2025 Nauman Arshad
- Keywords
- Low Level Laser Therapy, LLLT, Micro-Osteoperforations, Canine Retraction, Maxillary Scan
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 33 participants (estimated)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- Jun 2026 (estimated)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 4 Jun 2026 (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.
Orthodontic treatment is often prolonged, requiring years to achieve desirable outcomes. The prolonged duration of treatment increases the risk of complications such as root resorption, periodontal damage, and patient non-compliance.
To address these concerns, various methods have been explored to accelerate orthodontic tooth movement, including pharmacological agents, mechanical vibration, corticotomies, and minimally invasive techniques like Micro-Osteoperforations (MOPs) and Low-Level Laser Therapy (LLLT). Micro-Osteoperforations (MOPs) have gained popularity as a minimally invasive technique that enhances bone remodeling by inducing a localized inflammatory response, thereby accelerating tooth movement.
Studies have shown that MOPs can effectively stimulate the expression of cytokines, increasing osteoclastic activity and facilitating rapid orthodontic tooth movement. However, the extent of its effectiveness varies among individuals, necessitating additional interventions to maximize efficiency. Low-Level Laser Therapy (LLLT), also known as photobiomodulation, is another promising adjunct in orthodontics. LLLT has been reported to enhance cellular activity, promote osteoblastic and osteoclastic function, and improve tissue healing, leading to accelerated tooth movement. Several studies suggest that LLLT alone can expedite orthodontic treatment, but its combination with MOPs has not been extensively explored.
This study aims to compare the rate of orthodontic tooth movement between MOPs alone and MOPs combined with LLLT. By evaluating these two techniques, this research seeks to determine whether LLLT enhances the effectiveness of MOPs in accelerating tooth movement. The findings of this study could provide valuable insights into optimizing orthodontic treatment duration while minimizing potential risks and discomfort for patients.
Detailed description
INTRODUCTION
Orthodontic treatment is often prolonged, requiring years to achieve desirable outcomes. The prolonged duration of treatment increases the risk of complications such as root resorption, periodontal damage, and patient non-compliance.
To address these concerns, various methods have been explored to accelerate orthodontic tooth movement, including pharmacological agents, mechanical vibration, corticotomies, and minimally invasive techniques like Micro-Osteoperforations (MOPs) and Low-Level Laser Therapy (LLLT). Micro-Osteoperforations (MOPs) have gained popularity as a minimally invasive technique that enhances bone remodeling by inducing a localized inflammatory response, thereby accelerating tooth movement.
Studies have shown that MOPs can effectively stimulate the expression of cytokines, increasing osteoclastic activity and facilitating rapid orthodontic tooth movement. However, the extent of its effectiveness varies among individuals, necessitating additional interventions to maximize efficiency. Low-Level Laser Therapy (LLLT), also known as photobiomodulation, is another promising adjunct in orthodontics. LLLT has been reported to enhance cellular activity, promote osteoblastic and osteoclastic function, and improve tissue healing, leading to accelerated tooth movement. Several studies suggest that LLLT alone can expedite orthodontic treatment, but its combination with MOPs has not been extensively explored.
This study aims to compare the rate of orthodontic tooth movement between MOPs alone and MOPs combined with LLLT. By evaluating these two techniques, this research seeks to determine whether LLLT enhances the effectiveness of MOPs in accelerating tooth movement. The findings of this study could provide valuable insights into optimizing orthodontic treatment duration while minimizing potential risks and discomfort for patients.
OBJECTIVE: To compare the rate of orthodontic tooth movement between MOPs alone and MOPs combined with LLLT.
HYPOTHESIS:
Null Hypothesis (H₀):
There is no significant difference in the rate of tooth movement between patients who undergo Micro-Osteoperforations (MOPs) alone and those who undergo Micro-Osteoperforations combined with Low-Level Laser Therapy (LLLT).
Alternative Hypothesis (H₁):
The rate of tooth movement is significantly higher in patients who undergo Micro-Osteoperforations combined with Low-Level Laser Therapy (LLLT) compared to those who undergo Micro-Osteoperforations (MOPs) alone.
OPERATIONAL DEFINITIONS:
- Rate of Tooth Movement: The rate of tooth movement refers to the measurable change in the position of a tooth over a specific period of time, expressed in millimeters per month. This measurement is typically taken at regular intervals using clinical assessments, such as digital calipers or radiographs (e.g., periapical radiographs or CBCT scans) to accurately track the movement of the tooth. The rate of tooth movement is calculated by dividing the total distance moved by the number of months it takes to achieve that movement.
- Visual Analog Scale (VAS): The Visual Analog Scale (VAS) is a simple and widely used scale that provides a continuous measure of intensity along a straight line, typically 10 cm long. One end of the line represents no pain (usually labeled as "0"), and the other end represents the worst possible pain (labeled as "10").
- Root resorption: It is measured as the loss of root structure, quantified by the degree of reduction in root length or volume. It will be assessed using Cone Beam Computed Tomography (CBCT) or periapical radiographs, where the degree of resorption is categorized into different levels based on observable changes in the root morphology:
- None: No evidence of root resorption.
- Mild: Minimal loss of root structure, less than 10% of the root length or volume affected.
- Moderate: Moderate loss of root structure, between 10-30% of the root length or volume affected.
- Severe: Significant loss of root structure, greater than 30% of the root length or volume affected.
MATERIAL \& METHOD:
Study Design: Split mouth Randomized controlled trial (One side of each patient's mouth will be designated as Group A, while the other side will be assigned to Group B)
SELECTION CRITERIA:
Inclusion Criteria:
- Patients aged 12-30 years requiring fixed orthodontic treatment.
- Patients with Class I or mild-to-moderate Class II malocclusion requiring canine retraction.
- No history of previous orthodontic treatment.
- Patients with indications for the extraction of the first premolars on both sides of the maxilla.
Exclusion criteria:
- Patients with systemic conditions affecting bone metabolism (e.g., osteoporosis, diabetes).
- Smokers and individuals with poor oral hygiene.
- Pregnant or lactating women.
Sample Size:
It will be a randomized controlled trial. Each patient would receive MOP on one side and MOP + Laser on the other side, randomly assigned.
33 subjects, for a total sample size of 66. n = 2(1.96 + 0.84)2 (0.48)2 / (0.53)2 = 32.4
Materials:
Diode Laser: Woodpecker LX16 Plus Diode Laser (976± 20nm) Micro-osteoperforations: GNI Mini Screws dimensions 1.8mm to 8mm
Methodology:
After the approval of ethical committee of Riphah International University, Islamabad, Pakistan, patients fulfill the selection criteria will be enrolled. A written informed consent will be taken from patients. A total of 66 participants will be enrolled in the study. One side of each patient's mouth will be designated as Group A, while the other side will be assigned to Group B using the block randomization method. Group A will undergo micro-osteoperforations at designated sites along the extraction space, while Group B will receive micro-osteoperforations in combination with Low-Level Laser Therapy at specified intervals. The intervention protocol consists of two approaches: Micro-Osteoperforations (MOPs) alone and Micro-Osteoperforations combined with Low-Level Laser Therapy (LLLT). MOPs will be performed using a sterile surgical instrument under local anesthesia, ensuring patient comfort during the procedure. Small perforations will be created in the alveolar bone adjacent to the tooth undergoing orthodontic movement. These perforations are intended to stimulate localized bone remodeling by enhancing osteoclastic activity, thereby facilitating a faster rate of tooth movement. For patients in the LLLT group, a diode laser with a wavelength of 600-1000 nm will be applied at predetermined power settings and specific time intervals following the MOPs procedure. The application of LLLT is expected to enhance cellular activity, promote osteoblastic and osteoclastic function, and accelerate tooth movement while potentially reducing post-procedural discomfort and inflammation. The primary outcome measure of this study will be the rate of orthodontic tooth movement, quantified in millimeters per month to determine the efficacy of each intervention. Secondary outcome measures will include pain levels, assessed using the Visual Analog Scale (VAS) to evaluate patient discomfort; root resorption, measured through Cone Beam Computed Tomography (CBCT) or periapical radiographs to assess any structural changes in dental roots; and patient compliance and satisfaction, which will be recorded through self-reported feedback and adherence to treatment protocols. A predesign structured questionere will be used to collect data.
DATA ANALYSIS PROCEDURE: Gathered data will be entered and analyzed by the computer software Statistical Package for Social Sciences (SPSS) Version 25. The results for all Quantitative variables: age, Rate of tooth movement, Pain levels and Root resorption will be expressed as mean ± SD. Frequency and percentages will be calculated for categorical variables such as gender, different levels of pain (e.g., no pain, mild pain, moderate pain, severe pain), Root resorption e.g., none, mild, moderate, severe and Patient compliance and satisfaction. Effect modifier such as age, gender, will be addressed through post stratification. Post stratification chi square test or Fisher's exact test will be applied in which p value of < 0.05 will be significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right side LLLT + MOP, Left side MOP only | Experimental | Other: Micro-osteoperforation, Device: Low Level Laser Therapy and Micro-osteoperforations CombinedGroup A will undergo micro-osteoperforations on Left side and Microosteoperforations with Low Level Laser Therapy combined on Right side of the Maxillary Arch |
| Right side MOP only, Left side LLLT + MOP | Experimental | Other: Micro-osteoperforation, Device: Low Level Laser Therapy and Micro-osteoperforations CombinedGroup B will undergo micro-osteoperforations on Right side and Microosteoperforations with Low Level Laser Therapy combined on Leftside of the Maxillary Arch |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- • Patients aged 12-30 years requiring fixed orthodontic treatment.
Key exclusion criteria (3 listed)
- • Patients with systemic conditions affecting bone metabolism (e.g., osteoporosis, diabetes).
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 |
|---|---|---|
| Micro-osteoperforationMOPs will be performed using a sterile surgical instrument under local anesthesia, ensuring patient comfort during the procedure. Small perforations will be created in the alveolar bone adjacent to the tooth undergoing orthodontic movement along the long axis of the tooth with rule of 3, 3mm difference between three sites along the distal root of Canine. The intervention was repeated after 3 weeks interval for 9 weeks. GNI Mini Screws 1.8 x 8 mm | Other | Right side LLLT + MOP, Left side MOP only, Right side MOP only, Left side LLLT + MOP |
| Low Level Laser Therapy and Micro-osteoperforations CombinedWoodpecker LX16 Plus Diode Laser (976± 20nm) will be applied at 5W and Frequency of 10000 Hz for 8 seconds producing a total of 8J Energy. MOPs will be performed using a sterile surgical instrument under local anesthesia, ensuring patient comfort during the procedure. Small perforations will be created in the alveolar bone adjacent to the tooth undergoing orthodontic movement along the long axis of the tooth with rule of 3, 3mm difference between three sites along the distal root of Canine. The intervention was repeated after 3 weeks interval for 9 weeks. GNI Mini Screws 1.8 x 8 mm | Device | Right side LLLT + MOP, Left side MOP only, Right side MOP only, Left side LLLT + MOP |
Primary outcome
Rate of Tooth Movement
Time frame: 3 weeks
To compare the rate of orthodontic tooth movement while retraction of Maxillary Canine in extracted first premolar sight between MOPs alone and MOPs combined with LLLT. The mesurements were done on Intraoral scan of Maxilla, before the experiment and after 9 weeks, the MOPs and LLLT were repeated after every 3 weeks.
2 secondary outcomes
Root Resorption
Time frame: 3 weeks
Pain in each visit
Time frame: 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Background: PubMed 36129485Moradinejad M, Chaharmahali R, Shamohammadi M, Mir M, Rakhshan V. Low-level laser therapy, piezocision, or their combination vs. conventional treatment for orthodontic tooth movement : A hierarchical 6-arm split-mouth randomized clinical trial. J Orofac Orthop. 2024 Mar;85(2):110-122. doi: 10.1007/s00056-022-00427-1. Epub 2022 Sep 21.
- Background: PubMed 39035342Huang CY, Le HHT, Tsai HC, Tang CH, Yu JH. The effect of low-level laser therapy on osteoclast differentiation: Clinical implications for tooth movement and bone density. J Dent Sci. 2024 Jul;19(3):1452-1460. doi: 10.1016/j.jds.2024.03.023. Epub 2024 Mar 30.
- Background: PubMed 38800347Alzahrani AM, Aljibrin FJ, Alqahtani AM, Saklou R, Alhassan IA, Alamer AH, Al Ameer MH, Hatami MS, Dahhas FY. Photobiomodulation in Orthodontics: Mechanisms and Clinical Efficacy for Faster Tooth Movement. Cureus. 2024 Apr 26;16(4):e59061. doi: 10.7759/cureus.59061. eCollection 2024 Apr.
- Background: PubMed 39204329Ciobotaru CD, Festila D, Dinte E, Muntean A, Bosca BA, Ionel A, Ilea A. Enhancement of Orthodontic Tooth Movement by Local Administration of Biofunctional Molecules: A Comprehensive Systematic Review. Pharmaceutics. 2024 Jul 25;16(8):984. doi: 10.3390/pharmaceutics16080984.
- BackgroundNarayan H. Gandedkar, Oyku Dalci, M. Ali Darendeliler, Accelerated orthodontics (AO): The past, present and the future, Seminars in Orthodontics, Volume 30, Issue 2, 2024, Pages 172-182, ISSN 1073-8746, https://doi.org/10.1053/j.sodo.2024.01.012.
- BackgroundDipalma, Gianna, Assunta Patano, Irene Ferrara, Fabio Viapiano, Anna Netti, Sabino Ceci, Daniela Azzollini, Anna Maria Ciocia, Giuseppina Malcangi, Alessio Danilo Inchingolo, and et al. 2023. "Acceleration Techniques for Teeth Movements in Extractive Orthodontic Therapy" Applied Sciences 13, no. 17: 9759. https://doi.org/10.3390/app13179759
- Background: PubMed 38951873Ramseier CA. Diagnostic measures for monitoring and follow-up in periodontology and implant dentistry. Periodontol 2000. 2024 Jun;95(1):129-155. doi: 10.1111/prd.12588. Epub 2024 Jul 1.
- Background: PubMed 38784082Pattanaik S, Veeraraghavan VP, Dasari AK, Patil SR, Alzahrani SG, Fareed M. Orthodontic treatment in adults: Challenges, outcomes, and factors affecting compliance and satisfaction. J Orthod Sci. 2024 May 8;13:14. doi: 10.4103/jos.jos_186_23. eCollection 2024.
- Individual participant dataSharing planned: No
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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.
Ulfat Bashir principal investigator
Riphah International 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 Micro-osteoperforation and Low Level Laser Therapy and Micro-osteoperforations Combined in people with Orthodontic Tooth Movement and Low Level Laser Therapy, run by Riphah International University 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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 4 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Imran Amjad, Phd (+923324390125, imran.amjad@riphah.edu.pk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Tooth Movement (time frame: 3 weeks). 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 NCT07626580, which also lists 8 linked publications.
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 4 Jun 2026.