None listed
Conditions
Brief summary
The purpose of this study is to investigate the effectiveness of low-level laser therapy in the management of orthodontic pain during orthodontic therapy and to see if it affects root resorption of teeth. The findings from this study will be compared to other related studies performed previously. By applying pain-free laser therapy on one side next to a tooth we hope to examine its effect on root resorption. This will increase our quality of care and help prevent this damage to patients’ teeth during treatment.
Interventions
Non-invasive low-level laser therapy using 808nm diode laser, energy per point 0.8J total power: 0.18W.
Participants will have partial braces placed on their upper back teeth, and they will attend the clinic 7 times during a 4 week study period for the laser to be applied, then on the 8th visit (day 28) the braces are removed and the upper first premolars will be extracted.
The study will end here and the patient will then continue normal orthodontic as needed.
Which will include full upper
Non-invasive low-level laser therapy using 808nm diode laser, energy per point 0.8J total power: 0.18W. Participants will have partial braces placed on their upper back teeth, and they will attend the clinic 7 times during a 4 week study period for the laser to be applied, then on the 8th visit (day 28) the braces are removed and the upper first premolars will be extracted. The study will end here and the patient will then continue normal orthodontic as needed. Which will include full upper and lower braces and the patient will continue with comprehensive orthodontic treatment- alignment, levelling, space closure and detailing. The duration of orthodontic treatment is dependent on each patients individual need. They are no longer enrolled in the study at this point. The study period is only 28 days. The low level laser therapy (LLLT) and sham laser is applied daily for the first 4 days of the study period, then weekly for 3 weeks. Laser and sham are applied on Day 0, 1, 2, 3, 7, 14, 21. The first appointment (day 0) takes 30 mins to place the braces and administer the laser (40s per side (total 80s) and visual analogue scale (VAS) to assess the pain. Then each subsequent laser session takes 40s per side (total 80s) each appointment is 5 minutes long to check on the braces and administer the laser and VAS. A qualified laser dentist administers the laser treatment The laser (for photobiomodulation) to accelerate orthodontic tooth movement is applied after the braces are placed and during buccal tipping of the upper first premolar. Laser therapy ceases 1 week prior to tooth extraction The laser is applied along the first premolar root, at 4 points along the premolar root (mesial and distal of the crystal, mid root and apex) - in a shape of a mercedes sign. The laser is applied on both the buccal and palatal surfaces i.e. 8 exposure per tooth 28 days after the braces are placed, they are removed and the premolar tooth is extracted. Adherence is strictly monitored, each patient is given a timetable prior to starting the trial to ensure they can attend all 8 sessions, and register of attendance is always taken. If a patient misses one appointment they are excluded from the study, although their orthodontic treatment will continue as per normal.
Sponsors
Doreen Ng
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
13 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Patient in permanent dentition must not have had any previous orthodontic treatment but requires orthodontic treatment now, They must have no pain/no orthodontic treatment at the beginning of the study. They must need bilateral maxillary first premolar extractions for orthodontic purposes to be included in the study. Apexification completed, Similar degree of minimal crowding on each side of the maxillary arch;
Exclusion criteria
No previous orthodontic or orthopaedic treatment; No craniofacial anomaly present; No previous reported or observed dental treatment of the maxillary canines; No history of trauma, bruxism or parafunction; No past and present signs and symptoms of periodontal disease; No significant medical history or medication that would adversely affect the development or structure of the teeth and jaws and any subsequent tooth movement.
Outcome results
None listed