Pain Clinical Trial
Official title:
Effect Of Low Level Laser Therapy on Tooth Movement,Gingival,Periodontal Tissue And Pain In Fixed Orthodontic Treatment
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.
Status | Not yet recruiting |
Enrollment | 88 |
Est. completion date | December 31, 2021 |
Est. primary completion date | November 30, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 30 Years |
Eligibility | Inclusion Criteria: 1. Selected patients will be Pakistani ethnic background. 2. Age 18 to 30 years. 3. Patients with class 1 with mild crowding (severity of malocclusion) according to little irregularity index to avoid individual variations. (Little, 1975) 4. Patient with healthy periodontium with no any sign of gingival inflamation. 5. Patients who indicated for orthodontic treatment with fixed appliances started with the conventional ligated brackets. 6. Patients who will sign consent for participation in research and use of collected specimen/data for future reference. 7. Patients who are able to read and understand English language because consent forms available only in language of English. 8. Patients with ovoid arch form to compact with laser assisted tray. Exclusion Criteria: 1. Patients on medications which alter the gingival health e.g. Phenytoin (Dilantin), Cyclosporine A (Sandimmun), Nifedipine (Adalat), Corticosteroids, contraceptive pills. 2. Patients on those medications which alter the bone metabolism or tooth movement e.g. NSAIDs, Corticosteroids, Bisphosphonates etc. 3. Patients with following disorder: Diabetes Type 1 and 2, Osteoporosis, Platelet disorders, Vitamin C deficiency, vascular conditions, Leukemia, HIV infection, crohn's disease. 4. Patients with pregnancy. 5. 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. - |
Country | Name | City | State |
---|---|---|---|
Pakistan | Aga Khan Hospital for Women Karimabad A secondary Hospital ofAga khan university Hospital | Karachi | Sindh Pakistan |
Lead Sponsor | Collaborator |
---|---|
Aga Khan University |
Pakistan,
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Hamdan AM. The relationship between patient, parent and clinician perceived need and normative orthodontic treatment need. Eur J Orthod. 2004 Jun;26(3):265-71. — View Citation
Jones ML, Chan C. Pain in the early stages of orthodontic treatment. J Clin Orthod. 1992 May;26(5):311-3. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pain associated with tooth movement: numerical rating scale | 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). | 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. | |
Secondary | Gingival index | The examination was performed by using a blunt probe (Löe, 1963).Measurement Zero healthy condition and rating at 3 shows severity of disease Score Criteria 0.No inflammation
Mild inflammation, slight change in color, slight edema, no bleeding on probing (Mild Gingivitis) Moderate inflammation, moderate glazing, redness, bleeding on probing (Moderate Gingivitis). Severe inflammation, marked redness and hypertrophy, ulceration, tendency to spontaneous bleeding (Severe Gingivitis) |
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 | |
Secondary | Bleeding on Probing | BOP tendency will be registered 20 seconds after probing. The following are the codes which will form the basis of the assessment for BOP (Lang, 1990) 0. Absent (on probing there is no bleeding)
1. Present (Bleeding after 20s of probing) |
To take examinations on each orthodontic treatment visit after every three weeks till six months | |
Secondary | Clinical Attachment Loss | It is measured by the distance between the cemento-enamel junction (CEJ) and thegingival margin (GM). (Armitage, 2004) Following is the classification of CAL Slight = 1-2 mm, Moderate = 3-4 mm, Severe = = 5mm) | To take examinations on each orthodontic treatment visit after every three weeks till six months | |
Secondary | Probing Depth | The PD will be measured to the nearest millimeter on the scale of the periodontal probe (Badersten, 1990). WHO Probe (CPITN Probe): The tip of the probe has a 0.5 mm ball at the tip and millimeter marking at 3.5, 8.5 and 11.5 mm and the color coding are 3.5 to 5.5 mm. | To take examinations on each orthodontic treatment visit after every three weeks till six months | |
Secondary | Rate of tooth movement: | The impressions for study models for measurement of tooth movement will be obtained from both groups consisted of Class I malocclusion with mild crowding patients treated orthodontically without extractions and patients with moderate irregularity scale of the index will be 2-4 according to Little's Irregularity Index. | 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. |
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