Tooth Migration clinical trials

Effects Of Low Level Laser Therapy On Tooth Movement,Treatment Related Complications Of Gingivitis,Periodontitis And Pain In Fixed Orthodontic Patients

INTRODUCTION Orthodontic treatment objectives are achieved through the movement of teeth with the application of an external physical force. It takes around 2 to 3 years to finish the treatment.The most common complications associated with orthodontic treatment are 1. Pain 2. Prolonged duration 3. Gingival and Periodontal complications So orthodontists, clinicians and researchers are always looking for some non-invasive and reliable techniques to minimize the possibility of occurrence of these complications. General objective The prime aim of this research is to study the effect of LLLT on tooth movement,pain, gingival and periodontal complications associated with tooth movement in initial phase of orthodontic treatment. Design of study This will be an experimental; case controlled study utilizing Low Level Laser Therapy in arch form of application.Anterior teeth segment of the maxillary jaw will be treated with LLLT in one group and other group of patients considered as control. Study population and samples This research will be conducted among Pakistani subjects who will be going for fix orthodontic treatment. Research subjects will be gathered from Aga Khan Hospital for Women Karimabad A secondary hospital of Aga Khan University Hospital of Karachi Pakistan. The duration of the study will be six months in which each patient will avail their regular follow up orthodontic treatment visits at every three weeks LLLT will be applied at every visit i.e. 0, 1, 2, 3, 4, 5 and 6th visits on anterior segment of the maxillary jaw in one group of patients, while the other group of patients will be controlled. The clinical parameters gingival index (GI), Bleeding on Probing (BOP), Probing Depth (PD) and clinical attachment loss (CAL) for the research will be recorded at 0, first, third and sixth visit. Study models to determine tooth movement will be taken in all visits from 0 to 6th visit. A Per forma to record the level of pain has been designed which will be given to all the patients at 0 to sixth all visits to record the pain intensity. Data will be recorded simultaneously. Sample frame The sample frame of patient recruitment for this research will be consisting of patients who will sign consent for this research and fulfill the inclusion and exclusion criteria. Sample size will be comprised of 88 pre-orthodontic patients, with an age range of 18 to 30 years. Sample size calculation Sample size will be determined by using PS software (version 3.1.2). To avoid individual variations, the patients will be divided into two groups randomly, using computer generated random numbers. Microsoft Excel 2013 will be used for group randomization. Group A and B will comprise of 36 patients (18 males and 18 females in each group) respectively and only Group A will receive LLLT on anterior segment of the maxillary jaw. However 20% drop out is considered which makes the sample size of 44 in each group at the beginning of study. Research tool The duration of the study will be 6 months in which each patient will visit on their regular follow up orthodontic treatment visits at every 3 weeks. LLLT will be applied at every visit i.e. 0, 1, 2, 3, 4, 5 and 6 months in patients of Group A. The clinical parameters Gingival Index, Bleeding on Probing (BOP), Probing Depth (PD) and Clinical Attachment Loss (CAL) for the research will be as recorded at 0, first, third and sixth visit of all patients of both groups. Conclusion The benefits of adopting LLLT (Low Level Laser Therapy) in an arch form in a routine orthodontic practice may enhance the rate of tooth movement, may be helpful to control orthodontic treatment related complications like pain, gingivitis and periodontitis with comfort and without disturbing patient regular recall visits.