- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07626580
Comparison of Rate of Tooth Movement Between MOPs vs MOPs & LLLT Combined
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.
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.
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Imran Amjad, Phd
- Telefonní číslo: +923324390125
- E-mail: imran.amjad@riphah.edu.pk
Studijní místa
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Punjab Province
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Islamabad, Punjab Province, Pákistán
- Islamic International Dental Hospital
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Kontakt:
- Ulfat Bashir, FCPS, MPH
- Telefonní číslo: +923335118561
- E-mail: ulfat.bashir@riphah.edu.pk
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Vrchní vyšetřovatel:
- Nauman Arshad, MDS
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Dílčí vyšetřovatel:
- Ulfat Bashir, FCPS, MPH
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: Right side LLLT + MOP, Left side MOP only
Group A will undergo micro-osteoperforations on Left side and Microosteoperforations with Low Level Laser Therapy combined on Right side of the Maxillary Arch
|
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 |
|
Experimentální: Right side MOP only, Left side LLLT + MOP
Group B will undergo micro-osteoperforations on Right side and Microosteoperforations with Low Level Laser Therapy combined on Leftside of the Maxillary Arch
|
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 |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Rate of Tooth Movement
Časové okno: 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.
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3 weeks
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Root Resorption
Časové okno: 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:
|
3 weeks
|
|
Pain in each visit
Časové okno: 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").
|
3 weeks
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Ulfat Bashir, Riphah International University
Publikace a užitečné odkazy
Obecné publikace
- 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.
- Huang 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.
- Alzahrani 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.
- Ciobotaru 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.
- Narayan 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.
- Pattanaik 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
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