Islamic International Dental Hospital
Islamabad, Punjab Province, Pakistan
Location contact
Nauman Arshad, MDS
PRINCIPAL_INVESTIGATOR
Ulfat Bashir, FCPS, MPH
CONTACT
Ulfat Bashir, FCPS, MPH
SUB_INVESTIGATOR
NCT Number: NCT07626580
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.
Trial opening soon.
Get Notified18 year–30 year
All sexes
Interventional
Not applicable
Islamabad, Punjab Province, Pakistan
Nauman Arshad, MDS
PRINCIPAL_INVESTIGATOR
Ulfat Bashir, FCPS, MPH
CONTACT
Ulfat Bashir, FCPS, MPH
SUB_INVESTIGATOR
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:
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
Exclusion criteria
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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.
Time frame: 3 weeks
: 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:
Time frame: 3 weeks
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").
Contact information is provided by the study sponsor or research team.
Riphah International University
Other
Comparison of Rate of Tooth Movement Between Micro-osteoperforations Versus Micro-osteoperforations and Low Level Laser Therapy Combined
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