Effect Of Low Level Laser Therapy on Tooth Movement,Gingival,Periodontal Tissue And Pain In Fixed Orthodontic Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Pain associated with tooth movement: numerical rating scale
研究概览
简要总结
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
- Pain
- Prolonged duration
- 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.
详细描述
INTRODUCTION Background Orthodontic treatment should be based on potential risks and benefit ,pledges appropriate positioning of teeth, corrects jaws and occlusal relationship that enhances mastication, speech, facial aesthetics and also promotes oral and general health which in its turn improves self-confidence of patient, thus bettering quality of life.
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. However, long duration of treatment and presence of orthodontic appliances is also associated with some risks and complications.
For above mentioned reasons, orthodontists and clinicians have been searching for effective methods to reduce patient discomfort, pain, longest duration of treatment and overcome treatment related gingival and periodontal issues that are not associated with undesirable effects over the course of treatment and on patient health.
For several years, research in laser endorses its use in the treatments involving clinical dentistry and is progressing gradually. Many practitioners have an association of love/hate relationship with bleaching lights and lasers. Laser phototherapy is non- invasive, non- pharmacological, has very rare adverse effects, is pain free and adores a high acceptance from clinicians and also patients.
Justification of the study orthodontic treatment is associated with some complications, particularly its long duration of treatment, and possibility of some adverse effects of treatment like pain, gingivitis and periodontitis, which are extremely bothersome for patients as well as practitioners.The use of LLLT is promising due to it's a non-invasive technique and has been reported with positive results for orthodontic tooth movements, pain and also in cases of gingival and periodontal complications by a number of previous studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Selected patients will be Pakistani ethnic background.
- •Age 18 to 30 years.
- •Patients with class 1 with mild crowding (severity of malocclusion) according to little irregularity index to avoid individual variations. (Little, 1975)
- •Patient with healthy periodontium with no any sign of gingival inflamation.
- •Patients who indicated for orthodontic treatment with fixed appliances started with the conventional ligated brackets.
- •Patients who will sign consent for participation in research and use of collected specimen/data for future reference.
- •Patients who are able to read and understand English language because consent forms available only in language of English.
- •Patients with ovoid arch form to compact with laser assisted tray.
排除标准
- •Patients on medications which alter the gingival health e.g. Phenytoin (Dilantin), Cyclosporine A (Sandimmun), Nifedipine (Adalat), Corticosteroids, contraceptive pills.
- •Patients on those medications which alter the bone metabolism or tooth movement e.g. NSAIDs, Corticosteroids, Bisphosphonates etc.
- •Patients with following disorder: Diabetes Type 1 and 2, Osteoporosis, Platelet disorders, Vitamin C deficiency, vascular conditions, Leukemia, HIV infection, crohn's disease.
- •Patients with pregnancy.
- •Patients with parafunctional habits, TMJ dysfunction, craniofacial malformation, multiple missing teeth, impacted teeth except third molars, or periodontally compromised patients will be excluded from the study.
研究组 & 干预措施
applied group
low level laser therapy applied in one group
干预措施: low level laser therapy (Device)
controlled group
other group will be controlled in which low level laser will not be applied
结局指标
主要结局
Pain associated with tooth movement: numerical rating scale
时间窗: A Performa to record the level of pain will be given to participants and advised to record the pain intensity for 7 days, experienced 2 hours after force application,as a primary outcome participants in experimental group may feel lesser pain.
To study the analgesic effect of Low- Level Laser Therapy, numerical rating scale (NRS) will be used (Bertl, 2012). This scale ranges from 0 to 10 where 0 denotes no pain and 10 signify unbearable pain. NRS scale is valid, reliable and easier to be used by patients as compared to other similar scales like VAS (visual analogue scale) (Brunelli, 2010).
次要结局
- Gingival index(To take examinations on each orthodontic treatment visit after every three weeks till six months of all participants of both groups,may show improvement in experimental group)
- Bleeding on Probing(To take examinations on each orthodontic treatment visit after every three weeks till six months)
- Clinical Attachment Loss(To take examinations on each orthodontic treatment visit after every three weeks till six months)
- Gingival index(To take examinations on each orthodontic treatment visit after every three weeks till six months of all participants of both groups,may show improvement in experimental group)
- Bleeding on Probing(To take examinations on each orthodontic treatment visit after every three weeks till six months)
- Clinical Attachment Loss(To take examinations on each orthodontic treatment visit after every three weeks till six months)
- Probing Depth(To take examinations on each orthodontic treatment visit after every three weeks till six months)
- Rate of tooth movement:(To study the effect of Low- Level Laser Therapy on tooth movement the study models to access tooth movement will be taken in all visits from 0 to 6th visit.)
研究者
kishore kumar
Consultant
Aga Khan University