- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02568436
Effect of Low Level Laser Therapy in Accelerating Tooth Movement For Dental Crowding Cases
Evaluation of Low-Level Laser Therapy (LLLT) Effectiveness in Accelerating Orthodontic Tooth Movement For Dental Crowding Cases: A Randomized Controlled Clinial Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The long time needed for orthodontic treatment is considered one of the biggest obstacles which make patients refuse to undergo treatment. It also has many disadvantages including higher caries rates, gingivitis, and root resorption. It also combined commonly with pain, which reducing patient acceptance and cooperation with treatment.
Low level laser therapy in orthodontic has shown pain-reducing effects with an effect in biomodulation which lead to increased orthodontic tooth movement rate and reducing risk of root resorption.
A recent systematic review states that low level laser therapy has shown efficiency in accelerating orthodontic tooth movement, but there is a need for more studies to determine the best protocols regarding energy and frequency. A review of the literature shows that there is no randomized controlled trails evaluating its efficiency in accelerating orthodontic tooth movement in regard of dental crowding cases, which is the main purpose of this study.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Damascus, Syrian Arab Republic, DM20AM18
- Department of Orthodontics, University of Damascus Dental School
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients aged between (16 - 24) years.
- Moderate crowding (3 - 5) mm in the anterior region of the maxillary dental arch with an irregularity index of (7 mm or more) mm according to Little Index with an indication to extract upper two premolars.
- All upper teeth are existed (except for third molars).
- Patients have not undergone previous orthodontic treatment.
- Patients have not undergone any medical treatment that interfere with orthodontic tooth movement (Cortisone, NSAIDs, …).
- Patient with good oral hygiene (Plaque Index less than 1).
Exclusion Criteria:
- Any medical condition affecting orthodontic tooth movement.
- Bad oral hygiene (Plaque Index greater than 1).
- Any peri-apical lesions developed during treatment.
- Patient lack of commitment toward follow-up appointments.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Conventional Decrowding
Crowded upper incisors will be treated in the conventional manner with a fake irradiation without using low level laser therapy.
|
|
Experimental: Low Level Laser Therapy
Each maxillary incisor will be subjected to low level laser therapy at specific times in order to accelerate tooth movement
|
low level laser therapy is intended to accelerate tooth movement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Overall Leveling and Alignment Time (OLAT)
Time Frame: This will be measured once the leveling and alignment stage of the orthodontic treatment is finished. This will be measured in days from the commencement of treatment till the final day of leveling and alignment.
|
As mentioned above
|
This will be measured once the leveling and alignment stage of the orthodontic treatment is finished. This will be measured in days from the commencement of treatment till the final day of leveling and alignment.
|
Change in Leveling and Alignment Improvement Percentage (LAIP)
Time Frame: this outcome will be measured after one month (T1) and two months (T2) of treatment commencement (T0), and at the end of leveling and alignment stage (T3) using Little irregularity index (LII)
|
LAIP will be measured by dividing the amount of change in LII value at a specific time intervals (i.e.
T3-T0, T2-T0, T1-T0; calculated by subtracting LII value at T1, T2 and T3 from LII value at (T0) by LII value at T0 (i.e. the beginning of treatment).
|
this outcome will be measured after one month (T1) and two months (T2) of treatment commencement (T0), and at the end of leveling and alignment stage (T3) using Little irregularity index (LII)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of levels of pain
Time Frame: Using a visual analog scale (VAS), pain will be measured after 1, 6, 24, 48, 72 hours of applying the laser therapy and at 7 days of follow-up.
|
Using a visual analog scale, each patient will indicate the severity of his/her perceived pain.
|
Using a visual analog scale (VAS), pain will be measured after 1, 6, 24, 48, 72 hours of applying the laser therapy and at 7 days of follow-up.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mohammad Moaffak Al-Sayed Hasan, DDS, MSc student at the Orthodontic Department, University of Damascus Dental School
- Study Director: Kinda Sultan, DDS MSc PhD, Senior Lecturer in Orthodontics, University of Damascus Dental School, SYRIA
- Study Director: Omar Hamadah, DDS MSc PhD, Senior Lecturer, Oral Medicine Department, University of Damascus Dental School, Damascus, Syria
Publications and helpful links
General Publications
- Kau CH, Kantarci A, Shaughnessy T, Vachiramon A, Santiwong P, de la Fuente A, Skrenes D, Ma D, Brawn P. Photobiomodulation accelerates orthodontic alignment in the early phase of treatment. Prog Orthod. 2013 Sep 19;14:30. doi: 10.1186/2196-1042-14-30.
- Doshi-Mehta G, Bhad-Patil WA. Efficacy of low-intensity laser therapy in reducing treatment time and orthodontic pain: a clinical investigation. Am J Orthod Dentofacial Orthop. 2012 Mar;141(3):289-297. doi: 10.1016/j.ajodo.2011.09.009.
- Cruz DR, Kohara EK, Ribeiro MS, Wetter NU. Effects of low-intensity laser therapy on the orthodontic movement velocity of human teeth: a preliminary study. Lasers Surg Med. 2004;35(2):117-20. doi: 10.1002/lsm.20076.
- Heravi F, Moradi A, Ahrari F. The effect of low level laser therapy on the rate of tooth movement and pain perception during canine retraction. Oral Health Dent Manag. 2014 Jun;13(2):183-8.
- Nobrega C, da Silva EM, de Macedo CR. Low-level laser therapy for treatment of pain associated with orthodontic elastomeric separator placement: a placebo-controlled randomized double-blind clinical trial. Photomed Laser Surg. 2013 Jan;31(1):10-6. doi: 10.1089/pho.2012.3338. Epub 2012 Nov 15.
- Tortamano A, Lenzi DC, Haddad AC, Bottino MC, Dominguez GC, Vigorito JW. Low-level laser therapy for pain caused by placement of the first orthodontic archwire: a randomized clinical trial. Am J Orthod Dentofacial Orthop. 2009 Nov;136(5):662-7. doi: 10.1016/j.ajodo.2008.06.028.
- AlSayed Hasan MMA, Sultan K, Ajaj M, Voborna I, Hamadah O. Low-level laser therapy effectiveness in reducing initial orthodontic archwire placement pain in premolars extraction cases: a single-blind, placebo-controlled, randomized clinical trial. BMC Oral Health. 2020 Jul 20;20(1):209. doi: 10.1186/s12903-020-01191-7.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- UDDS-Ortho-02-2015
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Maxillary Crowded Teeth
-
Damascus UniversityCompletedCrowded Teeth | Malocclusion, Angle Class ISyrian Arab Republic
-
Al-Azhar UniversityActive, not recruitingCrowding of Anterior Maxillary TeethEgypt
-
Damascus UniversityCompletedCrowding of Anterior Maxillary TeethSyrian Arab Republic
-
Cairo UniversityTerminatedBadly Decayed Anterior Maxillary TeethEgypt
-
Cairo UniversityUnknown
-
Cairo UniversityCompletedJumping Gap Dimension at Maxillary TeethEgypt
-
Taibah UniversityCompletedDental Extraction | Overcoming the Failure of Anaesthesia | Maxillary TeethSaudi Arabia
-
Cairo UniversityUnknownMissing Maxillary Anterior TeethEgypt
-
Damascus UniversityCompletedMalocclusion | Surgical Incision | Crowded TeethSyrian Arab Republic
-
Region Örebro CountyRecruitingCrowding of Anterior Maxillary Teeth | Orthodontics, Interceptive | Orthodontics, Corrective, Palatal Expansion TechniqueItaly, Sweden
Clinical Trials on low level laser therapy
-
Universidade Federal de Sao CarlosConselho Nacional de Desenvolvimento Científico e TecnológicoCompleted
-
University of Nove de JulhoSimone Aparecida Penimpedo Calamita; Fabiana Sarilho de Mendonça; Daniela Aparecida... and other collaboratorsCompleted
-
St. Elisabethen Krankenhaus Frankfurt GmbHRecruitingSurgical Scar Tissue of Cesarean Section or Vaginal Tear or EpisiotomyGermany
-
University of BergenCompleted
-
University of BergenNorwegian Fund for Postgraduate Training in PhysiotherapyCompleted
-
Universidade Federal de Sao CarlosFundação de Amparo à Pesquisa do Estado de São Paulo; Faculty of Medicine of... and other collaboratorsCompleted
-
University of OttawaBioFlexTM Laser TherapyCompletedProvoked VestibulodyniaCanada
-
NYU Langone HealthCompleted
-
Universidade do Vale do SapucaiCompletedBreast Neoplasms | Radiotherapy; Adverse Effect, Dermatitis or EczemaBrazil
-
University of Nove de JulhoConselho Nacional de Desenvolvimento Científico e TecnológicoNot yet recruitingPain, Postoperative | Endodontically Treated Teeth